To evaluate the effectiveness of low-dose gabapentin combined with imipramine, in treating cancer-related neuropathic pain

Patients were allocated to four groups. Group 1, consisting of 14 patients, received gabapentin 200 mg and imipramine 10 mg orally every 12 hours; Group 2, consisting of 14 patients, received gabapentin 200 mg orally every 12 hours; Group 3, consisting of 12 patients, received gabapentin 400 mg orally every 12 hours; and Group 4, consisting of 12 patients, received imipramine 10 mg orally every 12 hours. The average intensity of total pain over the past 12 hours was assessed, and the number of paroxysmal pain episodes in the past 24 hours were recorded. Pain was assessed at the first visit and seven days after the beginning of the regimen. Opioid rescue doses were available if needed.

• The sample consisted of 52 patients with solid tumors and neuropathic pain from nerve compression or spinal cord invasion.
• The mean age across groups was 65–69 years, range was 58–79 years.
• Men outnumbered women, 65% to 35%.

• Single-site outpatient setting
• Japan

Randomized, controlled trial

Pain was measured on a numeric scale, 1–10.

The total pain scores and daily paroxysmal pain episodes of the patients taking the low-dose gabapentin-imipramine combination (Group 1) decreased significantly (p < 0.05). The combination significantly decreased the previous 24-hour opioid rescue dose. Researchers observed mild adverse symptoms in all four groups. Symptoms included drowsiness, dizziness, and nausea. Note: Three patients dropped out of Group 3 because of adverse effects.

The combination of gabapentin and imipramine in low doses offers a means of successfully treating neuropathic pain, with minimal side effects.

• The small total sample size (< 100 participants) and the use of a single pain measurement scale are limitations.
• The results may not be reproduceable.
• Generalizing results to chemotherapy-induced neuropathic pain may be inappropriate.

The gabapentin-imipramine combination is effective in treating neuropathic pain caused by nerve compression or invasion of the spinal cord.

To evaluate the efficacy of the psychoeducational program in alleviating cancer-related fatigue and mood symptoms, and improving quality of life among breast cancer survivors

• N = 40 for the intervention group, 40 for the control group (waiting control)   
• AGE = 42.1 years (9.7) for the intervention, 41.8 years (10.3) for the control group
• FEMALES: 100%
• CURRENT TREATMENT: Radiation 
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Nonmetastatic breast cancer, stages 1 and 2, Karnofsky Performance Scale (KPS) scores of 70 and more

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: At the outpatient clinic in the Department of Clinical Oncology in the Faculty of Medicine, Cairo University, Egypt

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Palliative care 

Case control study

• Multidimensional Fatigue Inventory SF-36 (MFI SF-36) 
• Hospital Anxiety and Depression Scale (HADS)

The four-week psychoeducational program improved fatigue and quality of life after radiation therapy in patients with breast cancer.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Selective outcomes reporting
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity

The intervention may be taught by trained nurses and can be part of a routine supportive care at very low additional costs for healthcare systems.

To evaluate the effects of oral zinc sulfate on prevention of mucositis, xerostomia, and pain induced by chemotherapy.

Patients were divided by block randomization into two groups of zinc sulfate and placebo. Patients were informed about oral hygiene and associated care. Patients in the intervention group took three 220 mg zinc sulfate capsules daily until the end of chemotherapy treatment. The placebo group took three placebo capsules that were similar in shape, taste, and color to the zinc sulfate capsules. Randomized divisions and zinc sulfate drug prescription of patients were carried out by patients’ oncologists. Patients' mucous and salivary health was checked by an oral medicine specialist and dental student prior to the initiation of chemotherapy, two weeks after initiation of chemotherapy, and every two weeks until the end of chemotherapy. The specialist and dental student were blinded to the randomization and treatment.

The study was comprised of 50 adult patients over the age of 18.

MALES 52%, FEMALES 48%

OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria were chemotherapy treatment by a regimen with the same mucositis probability, including cyclophosphamide, doxorubicin, dacarbazine, gemcitabine, methotrexate, and 5-fluorouracil. Exclusion criteria included previous or simultaneous radiotherapy in the head and neck region, including the nasopharynx, oropharynx, and larynx, previous head and neck surgery due to malignancy, use of dentures, pregnancy, and infection.  

 

SITE: Single site

LOCATION: Oncology Department at Zahedan Imam Ali Hospital, Zahedan, Iran

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Late effects and survivorship elderly care, end-of-life and palliative care
 

A double-blind, randomized study where subjects were divided by block randomization into two groups of zinc sulfate and placebo.

• Oral mucositis was graded from 0 to 4, using World Health Organization (WHO) criteria.  
• Xerostomia was diagnosed from 1 to 4 using the LENT SOMA scale.  
• The degree of pain was evaluated based on a visual analog scale.
• For quality of life, patients individually met with the dental student at each follow-up, and the student completed the EORTC LQ-OES18.
   

Xerostomia: Baseline of all patient’s salivary flows were within normal range, p = 0.13. At the first visit (during the second week of chemo), no significant differences in xerostomia were seen between groups p = 0.019. At the second visit (during the fourth week of chemo), the intensity of xerostomia in the drug group was less than the placebo, p < 0.005, and this trend continued in the 8th and 16th weeks of treatment. At the beginning of the study, none of the patients had symptoms of mucositis. During the frst, second, and third visits, there were no significant differences in mucositis intensity between groups. At weeks 8, 12, and 16 of chemo, there were significant differences between both groups. The intervention group had less intensity than the placebo group, p < 0.005. Regarding pain intensity from the third visit (wk 6 chemo) until the 10th visit (wk 20), there were significant differences between groups, indicating that pain intensity in the drug groups was less than in the placebo groups, p < 0.005.

Recovery: Mucosiits recovery period is the time interval between appearance of mucositis s/s and complete resolution. The recovery period was seven weeks and three days for the zinc treatment group and eight weeks for the placebo group, p = 0.13.

Xerostomia recovery period for xerostomia was from the time of appearance of the s/s and the complete resolution. Seven weeks in the placebo groups versus six weeks and five days in the zinc group, no significant difference was noted between the groups, p = 0.23.
 

The use of zinc sulfate was able to decrease the intensity of xerostomia, mucositis, and pain in patients that develop chemotherapy induced mucositis. There was no difference between the incidence of mucositis or delay in developing mucositis between the zinc sulfate and placebo group. The recovery period for xerostomia to complete resolution was not statistically significant between groups.

• Small sample <100
• It is not clear whether the 50 initial participants were all studied for the entire duration. There is no mention of dropouts. No information is available on patient adherence to doses and oral care plan.
   

The use of zinc sulfate might decrease the intensity of mucositis, which could help with patient compliance with treatment, affect weight loss from poor nutrition, and decrease the need for hydration.

To evaluate the use of silver leaf nylon dressings as a prophylactic measure to reduce inframammary fold radiation therapy (RT)–induced dermatitis in women receiving adjuvant whole-breast RT compared with standard skin care. The secondary objective was to evaluate if the dressing influenced breast skin–related pain, itching, and burning resulting from whole-breast RT.

Patients were randomized during their first week of RT using a random numbers table after stratification for prior anthracycline-based chemotherapy and duration of RT:  short course (42.5 Gy/16 fractions) or extended course (45-50 Gy/25-28 fractions).

Control Arm (n = 103):  Standard skin care recommendations included avoiding skin irritants, promoting clean skin using nonalkaline, unscented soap and water and patting skin dry, and maintaining skin hydration with twice daily (BID) application of moisturizing cream (patients chose which brand of cream they used). Pruritis or brisk erythema was managed with topical steroids. Moist desquamation was treated with BID saline compresses and hydrogel or silvadene cream.

Experimental Arm (n = 93):  Patients were supplied with dressings, sterile water, a cotton bra in the correct size, gauze, hypoallergenic tape, printed instructions, and teaching performed by RT therapists to show patients how to wear the dressing before day six of RT. Sterile water was used to moisten the dressing before applying it to the inframammary fold with gauze to cover it. This was held in place with the cotton bra and was to be worn 24 hours per day but removed for RT and bathing. The dressing was worn from day 6 of RT until 14 days after completion of whole-breast RT. Women in this arm also received standard skin care instruction. Patients were assessed one week before the last treatment, on the final day of treatment, and one week posttreatment (the time period when RT-induced dermatitis was likely to have appeared in the inframammary fold). Subjective and objective assessments of radiodermatitis in the inframammary fold were performed at these time points.

• The sample was comprised of 196 patients (100% female) with breast cancer.
• Mean age was 56 years in the control group and 58 years for silver leaf dressing group.
• Patients were undergoing whole-breast RT for in-situ or invasive breast cancer after breast-conserving surgery.
• Patients were excluded if they had an allergy to silver, significant connective tissue disease, known RT hypersensitivity syndrome, or significant wound complication (infection or dehiscence).

Canada:  The British Columbia Cancer Agency

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

• Digital photographs    
• Radiation Therapy Oncology Group (RTOG) visual score to grade acute toxicity of RT-induced skin erythema
• Breast questionnaires specifically developed for the study

• Objective data assessment:  RTOG scores showed no significant difference in the presence of or maximum area of moist desquamation, erythema, or RTOG skin toxicity between study arms.
• Subjective data assessment:  Symptoms of pain, burning, and itching increased during RT. Two weeks after completion of whole-breast RT, these symptoms had not returned to baseline. There was no difference between the study arms in patients reporting symptoms of pain or burning. In the last week of RT and one week post completion of RT, patient reports of itching decreased in the experimental arm (p = 0.013 and .019, respectively). Patients using Glaxal Base cream reported worse burning one week before RT finished (p = 0.02), and those who used aloe vera reported worse pain and burning (p = 0.006 and p = 0.003, respectively). Patients who had not used moisturizing cream reported less pain (p = 0.02).

The use of silver leaf nylon dressings as a prophylactic measure did not show benefit in reducing the degree of acute inframammary fold radiodermatitis in women receiving adjuvant whole-breast RT.

• Not applicable
• The authors identified potential reasons for negative outcomes:  weakness in study design/implementation or that the silver leaf dressing had no effect in preventing inframammary radiodermatitis.  

The prophylactic use of silver leaf nylon dressings decreased the patient-reported symptom of itching on the last day of RT and one week after completion of whole-breast RT. Dressings can provide patient comfort, and the use of dressings is supported perhaps on a more individual per-case basis; however, the results did not demonstrate a significant benefit for prophylactic silver leaf dressing use.

To evaluate a group-based mind-body medicine (MBM) program for its impact on fatigue persisting at least six months beyond completion of adjuvant radiation or chemotherapy treatment among breast cancer survivors.

A 10-week multimodal intervention was developed and pilot tested to address the needs of patients with breast cancer. Ten 1.5- to 2-hour weekly group sessions were held, with five to 10 breast cancer survivors per group. Techniques for cognitive restructuring, exercise, positive psychology and spirituality, yoga, nutrition, and alternative or complementary therapies were introduced sequentially at weekly intervals. Fatigue and mood were measured at baseline, the end of the intervention period, and two and six months postintervention.

• The study included 68 women with stage I to III breast cancer; seven patients dropped out, which left 61 patients available for evaluation.
• Age distribution and mean were not reported in the body of the article. A mean age of 56.8 years was reported in the abstract only.
• Of the patients, 49% were Caucasian, 39% were married, and 30% had a body mass index  (BMI) greater than 30 kg/m².
• Mean time posttreatment was 2.6 years.
• Patients were included if they
  • Were women aged 18 years and older
  • Had stage I to III breast cancer diagnosed within the past five years
  • Were currently disease-free
  • Were at least six months post-adjuvant therapy, with the exception of hormone therapy with trastuzumab
  • Had moderate-to-severe fatigue (measured by Short Form 36 [SF-36] vitality and fatigue subscale).
• The Physical Activity Readiness Questionnaire (PAR-Q) screening tool was used to determine the ability of patients to participate in the exercise component; no activity restrictions were identified.

The intervention was held at two sites in Maryland:  an urban community hospital and a semi-rural county health department.

• Patients were undergoing the long-term follow-up phase of care.
• The study has clinical applicability for late effects and survivorship.

The study followed a quasiexperimental, pre-/posttest design.

• PAR-Q
• Piper Fatigue Scale (PFS)
• 10-cm visual analog scale (VAS)
• Vitality subscale of the SF-36
   

• Outcomes were assessed through self-administered questionnaires at the final session, and subsequently at two and six months following the final session. 
• Improvement was noted by all three measures; fatigue decreased and vitality and energy increased significantly from baseline to the end of the program, and additional improvement was observed at two and six months following the intervention. 
• The authors stated that “steady week-to-week improvements\" in fatigue supported that the change in fatigue was a result of the intervention; however, they did not measure fatigue on a week-to-week basis.
• Fatigue scores decreased by 40% at six months after completion of the 10-week program (p < 0.001 for both PFS and VAS). 
• SF-36 vitality subscores increased by 6% (p < 0.001). 
• Mood (VAS) improved parallel to the decrease in fatigue symptoms, with a 24% sustained improvement at six months compared to baseline scores (p < 0.004).
• Adjustments for covariates did not alter the results.

• The study had a small sample size, with less than 100 patients.
• Multimodal interventions have potential for numerous confounding variables and lack of control for variations within the intervention. 
• The question remains as to whether time is all that is required post-adjuvant treatment in the resolution of fatigue among breast cancer survivors. However, patients in this study completed adjuvant therapy an average of 2.6 years prior to the study, had persistent fatigue, and showed a marked improvement in fatigue scores (self-reported outcomes) measured over a 10-week period without additional intervention (if patients actually implemented any of the recommendations for exercise, nutrition, yoga, etc., then it was an additional intervention other than the group sessions. The authors did not measure adherence to these recommendations, which could have impacted the outcome of fatigue).
• Comparison to other studies using a similar approach is difficult given the lack of extensive evaluation of multipronged interventions.
   

Randomized, controlled studies should be conducted to confirm the efficacy of this program intervention. Nurses and interdisciplinary team members may help breast cancer survivors to reduce persistent fatigue through a multipronged programmatic approach focusing on stress reduction, cognitive-behavioral techniques to achieve positive change, nutrition, and physical activity.

A systematic review was used.

• Databases used for the literature search were PubMed, Embase, CINAHL, PsycINFO, and Cochrane Library.
• Key words were cancer caregivers, caregiver burden, and psychosocial interventions.
• Literature addressing the nonprofessional caregivers of people with illness/disease AND the psychosocial impact of the informal caregiver (IC) role AND interventions or coping mechanisms that ease negative impacts of the role was included in the search.
• Noncaregiver participants, nonpatients with cancer, and foreign language articles were excluded from the study.

• A total of 2,199 references were retrieved.
• Two authors performed an initial article title and abstract scan and narrowed the sample to 76 articles.
• Both authors reviewed each of the articles for inclusion and resolved differences of opinion through discussion.

• The review included a final number of 49 studies.   
• Sample range across studies was 8–760.
• Of the studies reviewed, 36 described in-person interventions, 3 described phone-based interventions, and 10 described combined in-person and phone-based intervention strategies.

• Multiple phases of care    
• Pediatrics; elder care; palliative care

Eight major categories of intervention were identified: psychoeducation, problem-solving/skill-building, supportive therapy, family/couples therapy, cognitive-behavioral therapy, interpersonal therapy, complementary and alternative medicine, and existential therapy.

Psychoeducation: Six of nine studies in this category focused on the educational needs of the IC (primarily spouses) at the time of cancer diagnosis or in early-stage disease. Three of nine were targeted to IC/patient dyads with advanced cancer. The IC’s knowledge and ability to provide care was improved, and some studies illustrated positive changes in psychological correlates of caregiver burden as well as level of functional support offered to the patient and marital satisfaction.

Problem-solving/skill-building: Ten studies evaluated the impact of enhancing caregiver ability and confidence to provide care. The majority of studies focused on spouses/partners, one on mothers, and two did not specify the relationship between the IC and patient. Half of the studies provided the intervention to the IC alone, the others to an IC/patient dyad. Eight studies reported significant and positive effects on the psychological correlates of caregiver burden and problem-solving skills.

Supportive therapy: Eight studies evaluated the impact of in-person group therapy (in some studies supplemented by additional phone support), five were targeted to ICs of patients with advanced disease, and three were for ICs of all-stage patients. Five studies utilized groups comprised of ICs alone, and three included IC/patient dyads. Results were generally qualitative, but in those studies where outcomes related to psychological correlates of caregiver burden were measured, one study found improvements by ICs in perceived support and knowledge, and other studies found no significant changes.

Family/couples therapy: Eleven studies focused on interventions to improve communication and psychological functioning of the “couple/family” unit. Of the seven couples-focused studies, all noted improvements by ICs and patients in relationship quality, physical and psychological functioning, communication, and sexual satisfaction. In the four family interventions, significant improvements in psychosocial distress and coping skills were observed. One family-based study, focused on newly diagnosed patients with pediatric cancer, failed to demonstrate significant improvements in anxiety or traumatic stress levels. 

Cognitive-behavioral therapy: Three studies focused on IC interventions using structured, multimodal interventions to impact sleep-wake disturbances, psychological distress, and negative reactions by ICs to patient-reported symptoms. Each study reported significantly positive outcomes postparticipation.

Interpersonal therapy: One study used a phone-based intervention to deliver interpersonal counseling to patients with breast cancer and their spouse caregivers over a six-week period. Significant improvements in depression and anxiety in both parties were reported.

Complementary and alternative medicine interventions: Two studies examined the impact of complementary and alternative medicine therapies. One studied an eight-week, nurse-delivered program of guided imagery, reflexology, and reminiscence therapy to patients and ICs, alternately in person and by phone, but the author collected no psychosocial outcome data. A second study compared massage therapy versus Healing Touch to manage anxiety, depression, fatigue, and subjective caregiver burden on ICs of patients undergoing stem cell transplantation. Significant improvements in anxiety, depression, and physical and emotional fatigue were reported in the subjects who received massage, but neither group noted improved perception of burden.

Existential therapy: One study examined the impact of participation in a theory-based, hope-focused activity on live-in ICs. Qualitative results from the small sample (n = 10) indicated perceived benefits by the participants, such as reframing goals for hope and the value of focusing and sharing their thoughts.

Of the 49 studies reviewed, 65% produced positive improvements in outcomes for ICs and patients, although specific statistical results and effect sizes were not reported. The authors noted that multiple studies did not collect outcome data sufficient to support full comparisons across all studies.

Overall, the body of these studies illustrated that a significant need exists among ICs for information on how to cope with not only their patient’s physical and psychosocial needs but their own as well. The studies that provided concrete skill-building and education (psychoeducational, problem-solving/skill-building, and cognitive-behavioral therapy) met these needs and demonstrated improved outcomes most clearly. Studies with interventions intended to manage psychosocial distress (supportive therapy, family/couples therapy, interpersonal therapy, and existential therapy) generally demonstrated qualitative data indicative of improvements in the psychological correlates of caregiver burden and improved communication, but fewer measured and reported quantitative outcome data allowing larger comparisons of short- or longer-term effectiveness.

The authors of two of the supportive therapy studies noted that during recruitment, ICs with higher baseline levels of psychosocial distress tended to decline participation; therefore, the recruited sample’s mean level of distress at study start was already low to moderate, leaving less opportunity to demonstrate statistically significant change.

A wide variety of interventions to support the educational and psychosocial needs of ICs have been explored, allowing nurses to provide or refer ICs and patients to therapies or structured programs that are best suited to their needs. Some of the interventions are within nursing scope of practice, such as massage, whereas others might require referral to a formal individual or group therapy provider. Structured intervention programs, such as those described in the cognitive-behavioral therapy studies, may be able to be replicated locally.

To assess the effects of various analgesic options, particularly transdermal buprenorphine, on cancer-related pain

This study is a multicenter trial in which participants were patients with advanced solid tumors and persistent cancer-related pain that required analgesic treatment. For one month investigators collected descriptive data, including data from screening and weekly assessments and data related to medical history, examination findings, medications, analgesic consumption, pain assessment, satisfaction with pain treatment, and patient self-reports of quality of life. Data were collected up to the final visit, at week 12. This study did not describe specific pain interventions. Data relating to various subgroups were described and analyzed.

• The sample was composed of 398 patients.
• Mean patient age was 64.4 years.
• Of all patients, 43.9% were female and 56.1% were male.
• The sample comprised a variety of cancer types.
• Of all patients, 64.6% were initially on transdermal buprenorphine at study baseline. During the study the remaining patients switched to buprenorphine from another treatment. Most patients were receiving nonsteroidal anti-inflammatory drugs, and many patients were also taking steroids.
• Of all patients, 42% had concurrent chemotherapy and bone metastasis.
• Worst average pain intensity at baseline was 2.1 among those who initially were receiving buprenorphine. Among those taking a different initial medication, the average pain intensity was 1.6.
• Of all patients, 25.9% had neuropathic pain.

• Multisite
• Multiple outpatient and inpatient settings in Italy

Nonrandomized open-label prospective, descriptive study

• Brief Pain Inventory (five items)
• Eleven-point rating scale, to measure pain
• Seven-point verbal scale, with care scale, to measure satisfaction
• Seven-point numeric rating scale, to measure quality of life
• Four-point verbal rating scale (1 = absent, 4 = very much), to measure side effects

• The most frequent side effects were constipation and sedation. Overall, transdermal buprenorphine was well tolerated.
• When compared to patients using World Health Organization (WHO) level III drugs other than buprenorphine (mean change in overall pain =  –17.7), patients using transdermal buprenorphine (mean change in overall pain = –25.8) had consistently higher levels of improvement in all pain measures and greater levels of pain relief.
• In regard to pain relief, of patients receiving buprenorphine, 19% expressed decreased or worsened satisfaction. Authors determined that approximately 30% of patients could be considered poor responders to buprenorphine.

Patients using transdermal buprenorphine tend to show more pain reduction than patients who are taking other WHO level III analgesia. The majority of patients seem to tolerate transdermal buprenorphine well. Approximately 30% of patients were unresponsive to transdermal buprenorphine.

• The study had a risk of bias due to no appropriate control group.
• Although authors provided much analytic data, they did not present statistical tests of significance of trends over time or cite differences in group outcomes,
• Given the setting of chronic cancer-related pain, observations were made over a relatively short period.

Transdermal buprenorphine may be a helpful alternative and adjunct in the management of cancer-related pain. Note that approximately one-third of patients in the study did not respond to this medication. Other studies have shown that absorption of transdermal medication varies among individuals. Findings point to the importance, in ensuring optimal pain management, of timely and consistent pain reassessment, particularly if switching from one approach to another or when adding medications to a regimen.

To study the safety and efficacy of TJ-14 in preventing or treating chemotherapy-induced mucositis versus a placebo in patients with gastric cancer

Patients who identified a Common Terminology Criteria for Adverse Events (CTCAE version 4) grade 1 or greater mucositis were randomized on a one-to-one ratio and stratified according to age, chemotherapy regimen, institution, and previous treatment for oral mucositis. Participants received either TJ-14 or a placebo beginning with their next cycle of chemotherapy. The placebo was prepared to mimic the intervention. TJ-14 and the placebo were given three times per day. Patients were instructed to dissolve 2.5 g (total daily dose 7.5 g) of either TJ-14 or the placebo in 50 mL of regular drinking water and to rinse the oral cavity for 10 seconds. Treatment began on the first day of the protocol treatment, continued till the final day, and was administered as much as possible for one course of treatment. No other mouthwash prophylactic interventions for oral mucositis were allowed during the trial period. Assessments took place during the screening cycle from the beginning of the protocol treatment or the appearance of mucositis until all symptoms disappeared.

• N = 91
• AVERAGE AGE = 68 years
• MALES: 62.2% (TJ-14); 60.9% (placebo), FEMALES: 37.8% (TJ-14); 39.1% (placebo)
• KEY DISEASE CHARACTERISTICS: Patients with gastric cancer who developed an oral mucositis score > 1 on the CTCAE scale during the screening cycle of chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: None

• SITE: Multi-institutional facilities           
• SETTING TYPE: Cancer center
• LOCATION: Japan

• PHASE OF CARE: Active treatment
• APPLICATIONS: Elder care, palliative care 

Randomized, double-blinded, controlled, phase II trial

• The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0
• Time to resolution of mucositis was defined by the authors as the time from the initiation of the protocol treatment or the first day of mucositis to the day when the patient was symptom-free.
• Patients self-reported the ability to eat solid foods.
• Physical examinations, laboratory evaluations, and the reporting of adverse events were used to evaluate safety.

In this study, 40% of patients in the intervention group and 41.3% of patients in the placebo group experienced ≥ grade 2 oral mucositis, and there was no difference between the groups (p = .588). In addition, there was no difference between the two groups concerning the duration of oral mucositis (p = .937).

This study did not demonstrate any beneficial effects of TJ-14 in reducing the incidence of chemotherapy-induced oral mucositis.

• Small sample (< 100)
• Other limitations/explanation: It is possible that dose reductions in chemotherapy affected the duration of the treatment instead of the standard treatment, which postpones chemotherapy because of mucositis.

No prophylactic or treatment-related benefits of TH-14 were evident in this study regardless of the grade of chemotherapy-induced oral mucositis. Nurses should consider other interventions for the prevention and treatment of oral mucositis.

Low-power laser therapy (LPLT) versus placebo

Only dentists knew the randomization.

Low level intensity laser: InGaAIP diode laser—660 nm, 46.7 mW

Predental care

Oral care: Extrasoft toothbrushes; dental paste with a peroxidase system after meals, and alcohol-free chlorhexidine solution until neutrophil recovery TID

Evaluations were performed daily by one dentist (not blinded) and three nurses (blinded).

Crossover allowed for control group patients who developed grade 4 oral mucositis.
 

The sample was comprised of 38 patients with HSCT.

Adults M =36.5/36.8

Women = 7/8
Men = 12/11

Autologous HSCT = 5/5

Allogenic HSCT = 14/14
 

Centro de Transplante de Medula Ossea

January 2004-May 2005

Randomized, placebo-controlled, quantity and prospective clinical trial

WHO scale

OMAS

VAS
 

All patients completed the study; none were lost to follow-up or excluded.

LPLT less intense oral mucositis
Grade 0 = 1, 63.2%, 12 of 19 versus 10.5%, 2 of 19 (p < 0.001)

6 LPLT, 31.5% WHO Grade 2

94.7% WHO 0–2

Control group was the opposite (data not provided) (p < 0.001).

Mucositis-free survival hazard ration grade 2, 3, and 4 was 0.41 (p = 0.002); the hazard ration grade for grade 3 and 4 was 0.07.

OMAS = 84.2% (16) patients receiving laser treatment stayed on a weighted average zone of 0–2.9 versus 26.3% (5) (p = 0.007).

Patients receiving laser treatment presented with small extension of ulcerous area (p = 0.003).

Control group showed mucositis earlier (D + 5) than laser group (D + 6) (p = 0.67, NS).

Longer duration 6 versus 9 (p = 0.13, NS)

Longer to heal (p = 0.15)
 

No differences in presence and intensity of pain

No differences in blood cultures

The level of agreement among evaluators was 81.7%.

Sample size

Implies difference when p value is not significant

Narrative frequently does not match p values.
 

To assess the efficacy of preventive low-laser therapy to reduce grade 3 and 4 oral mucositis (OM) in patients receiving chemoradiation

Both groups received cisplat 100 mg/m² for three cycles every three weeks, radiation 70.2 Gy (1.8 Gy per day five times per week), and the same oral hygiene. The intervention group received low-level laser therapy five times per week before every fraction of radiation. The energy and energy density were the same for each patient. A dentist applied the laser tip to the mucosa of the lips, the right and left buccal mucosa, the left and right lateral tongue border, the buccal floor, and the ventral tongue. The placebo group had the laser tip touched to the same sites, but there was no laser light.

• N = 94   
• AGE: 10–18 years
• MALES: Laser group: 89%, placebo: 85%; FEMALES: Laser group: 11%, placebo: 15%
• KEY DISEASE CHARACTERISTICS: Patients with squamous cell carcinoma of the head and neck
• OTHER KEY SAMPLE CHARACTERISTICS: Had to be ineligible for surgery, be able to tolerate chemo/radiation, have Eastern Cooperative Oncology Group status of 0 or 1, have had an intact oral mucosa at the start of the study

• SITE: Single site  
• SETTING TYPE: Outpatient   
• LOCATION: Brazilian National Cancer Institute in Rio de Janeiro

• PHASE OF CARE: Active antitumor treatment

• Prospective, randomized, double-blind, placebo-controlled, phase III trial

• World Health Organization Oral Mucositis Scale
• Oral Mucositis Assessment Scale
• Visual analog scale for pain
• The European Organization for Research and Treatment of Cancer QLQ-C30

A significant decrease was seen in the rate of grades 3 and 4 OM in the treatment group. Relative risk ratio (6.4% with laser versus 40.5% control) 0.158 (CI 95%). The treatment group reported better physical, emotional, fatigue, and pain scores and had less pain, fewer problems swallowing, and less trouble with social eating.

Low-level laser light therapy is effective in reducing grades 3 and 4 OM in patients with squamous cell carcinoma of the head and neck undergoing concurrent chemotherapy and radiation.

• Small sample (< 100)
• Findings not generalizable
• Intervention expensive, impractical, or training needs

Nurses who work in facilities with access to low-level laser light therapy should advocate for the use of it for their patients with head and neck cancer undergoing radiation and chemotherapy. There may be a role for nurses in learning to administer low-level laser light therapy.