STUDY PURPOSE: To evaluate the effects of ibandronate relative to placebo or zolendronate for treatment of skeletal-related events and bone pain in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 8; 4 comparing ibandronate to placebo and 4 comparing to zolendronate
• TOTAL PATIENTS INCLUDED IN REVIEW: 3,316
• SAMPLE RANGE ACROSS STUDIES: 44–1,400 patients
• KEY SAMPLE CHARACTERISTICS: Various tumor types; medications were given IV in some trials and orally in some trials

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Palliative care

IV or oral ibandronate was significantly better than placebo for pain reduction (WMD = -0.41, p < 0.00001). No significant differences in pain outcomes were seen between ibandronate and zoledronate. Incidence of renal toxicity was lower with ibandronate compared to zoledronate (RR = 0.71, p = 0.006). Incidence of skeletal-related events was lower with ibandronate compared to placebo (p = 0.002). There was no significant difference in skeletal-related events between ibandronate and zolendronate and no difference in other adverse events.

IV ibandronate every three to four weeks or daily oral medication was effective in reducing skeletal events and pain in patients with bone metastases, and was associated with lower incidence of renal toxicity than zoledronate.

• Almost all patients were Caucasian.
• No subgroup analysis between IV and oral ibandronate administration

Ibandronate is effective in reducing pain from bone metastases and multiple myeloma, and in preventing skeletal events in these patients, with efficacy similar to that of zoledronate. This analysis also showed that ibandronate was associated with lower prevalence of renal toxicity compared to zoledronate, so it may be a preferred choice for some patients with relevant comorbid conditions. Further research is needed to fully compare efficacy of oral versus IV administration.

The primary aim was to examine the effects of a nursing intervention for fatigue on children aged seven to 12 years who received chemotherapy. The secondary aim was to examine the relationship between fatigue and demographic variables, diagnoses, and therapy-related variables.

The experimental group received education about fatigue with chemotherapy and a fatigue handbook. Education provided included specific activities that decreased fatigue. Children were also walked in the hallway for physical activity. The control group was given routine nursing care. These activities were performed for one week. Participants were randomly assigned.

• The final sample size included 60 participants.
• Mean age was 9.23 years for the experimental group and 9.37 years for the control group. The percentage of males was 60% in the experimental group and 63.3% in the control group.
• Participants had acute lymphoblastic leukemia (ALL) (71.66%), acute myeloid leukemia (AML) (11.67%), and lymphoma (16.67%). 
• No significant differences were found between the groups in terms of age, diagnosis, sex, or hemoglobin level.

• Multisite
• Participants were recruited in the Department of Pediatric Oncology, Ege University Faculty of Medicine and Behçet Uz Hosptial of Children and SSK Tepecik Teaching Hospital, Clinics of Pediatrics.

This was a randomized, controlled trial.

• The Fatigue Scale-Child (FS-C) was used to measure participants’ fatigue and consisted of 14 items that describe the intensity of fatigue on a five-point scale.
• The Fatigue Scale-Parent (FS-P) used 17 items to assess parents’ perceptions of their child's fatigue on a five-point scale.
• The validity and reliability of both tests was assessed by 60 other similar children and parents.

The difference between the two mean values on the FS-C between the experimental and control groups was statistically significant (p < 0.00). The difference between the two mean values of the FS-P between the experimental and control groups was statistically significant (p < 0.00).

The study showed some promise for an intervention to reduce fatigue. However, fatigue was not eliminated in the experimental group, and baseline fatigue scores were not collected from either group.

• The control group received less attention.
• The experimental group had a limited age range and diagnosis, which may cause difficulty in generalizing the results.

It would be feasible to perform the study procedure for the experimental group in practice if the education continued to prove effective on fatigue.

To determine the effects of acupressure applied to the pericardium 6 (P 6) acupuncture point on chemotherapy-induced nausea and vomiting (CINV) and anxiety in patients with breast cancer undergoing chemotherapy

Stage 1–3 patients with breast cancer who were receiving cycle two and more advance-cycle chemotherapy in an ambulatory setting were trained to apply P 6 acupressure. Patients were randomly selected from a sample that met the study inclusion criteria. An acupressure wrist band was utilized with the research group. Patients were taught how to use the band with repeat demonstration. Patients continuously wore the acupressure band on both wrists for five days. Antiemetic medications used for the experimental and control group were not described.

• N = 64 
• AVERAGE AGE: 51.21 years (research arm); 50.87 years (control arm)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Stage 1–3 breast cancer after cycle two and more advance-cycle chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Breast cancer, female patients

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Turkey

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

• Quasi-experimental with a control group.
• Patients selected via randomized sample

• Beck Anxiety Inventory (BAI)
• Index of Nausea, Vomiting and Retching (INVR)
• Patient information form

The authors concluded that acupressure wristbands applied at the P 6 point decreased patients' nausea occurrence and experience and the overall experience and occurrence of nausea, vomiting, and retching combined. There was no effect on the occurrence or experience of vomiting or retching. Acupressure is an inexpensive intervention that may be able to provide additional relief to patients above and beyond recommended antiemetic therapy. Effects on anxiety are unclear.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• Other limitations/explanation: No discussion on why the researchers waited till cycle two to start intervention; prevention at the first cycle is key to good control; no sham band/possible placebo effect; significantly lower anxiety at baseline in the experimental group

Acupressure is inexpensive, is easy to use, and can be considered in conjugation with medication or CINV prophylaxis. Acupressure can be considered in addition to recommended antiemetic therapy for additional support of patients experiencing CINV.

To examine the efficiency of acupressure in controlling chemotherapy-induced nausea and vomiting (CINV) and to determine the factors that affect this efficiency

Turkish researchers recruited patients with lung, breast, and gynecological cancer who were undergoing active treatment with medicines such as doxorubicin- or cisplatin-based drugs. The researchers randomized and assigned 67 patients in the experimental group and 53 patients in the control group. The experimental group was given a real nausea wristband (Sea-Band), and the control group was given a placebo nausea band. All patients in both groups also were given standard antiemetic treatment. They were instructed to use the wristband on both of their wrists for five days, except when sleeping at night, washing their hands, and taking a shower.

• The study reported on 120 patients.
• Mean age was 55.11 years in the experimental group and 52.73 years in the control group.
• The sample was 50.8 male and 49.2 female.
• Cancer diagnoses were breast-gynecology (experimental group: n = 40 [59.7%], control group: n = 34 [64.2%]) and lung cancer (experimental group: n = 27 [40.3%], control group: n = 19 [35%]).
• Other key sample characteristics included the use of the following regimens.
  • Adriamycin-cyclophosphamide (experimental group: n = 12, control group: n = 4)
  • Cisplatin–etoposide (experimental group: n = 12, control group: n = 15)
  • Cisplatin–docetaxel (experimental group: n= 10, control group, n = 9)
  • Cisplatin–alimta/camptosar (experimental group: n = 5, control group: n = 5)
  • Cisplatin–gemcitabine (experimental group: n = 13, control group: n = 8)
  • 5 fluorouracil–adriamycin–cyclophosphamide/5 fluorouracil–epirubicin–cyclophosphamide (experimental group: n = 8, control group: n = 9)
  • Taxotere–adriamycin–cyclophosphamide (experimental group: n = 7, control group: n = 3)
  • Anthracycline-based (experimental group: n = 27, control group: n = 16)
  • Cisplatin-based (experimental group: n = 40, control group: n = 37)

The study was conducted at a single site in Turkey. The setting type was not specified.

Patients were undergoing the active treatment phase of care.

The study was a cross-sectional, single blinded study.

The researchers stated that they created a patient description form to collect the demographic information, chemotherapy medications, and characteristics of the condition of the patients. They also used two measurements. 

• The first was the Rhodes Index of Nausea Vomiting and Retching (INVR) scale, of which validity and reliability were confirmed in another Turkish study. Patients were asked to complete the INVR scale for five consecutive days. They rated their nausea and vomiting on a 0–4 scale, with a high score indicating a severe complaint.
• The second was the Functional Assessment of Cancer Therapy-General (FACT-G), which is a quality-of-life scale. They completed the FACT-G quality-of-life scale on the fifth day only. A high score in this scale indicates a high quality of life.

The researchers investigated whether acupressure affected the patients’ quality of life, as well as their experiences and development of nausea, vomiting, and retching. After five days of treatment, the results indicated that no statistically meaningful difference was observed between the control and experimental groups. Therefore, real acupressure application was not an effective strategy to increase the quality of life or to decrease the experience of CINV.

The statistical results show that after five days, both experimental and control groups had almost identical scores. Therefore, the real nausea wristband does not affect CINV or the quality of life.

The study shows that wristband acupressure is not effective in controlling CINV in patients with cancer. Additional studies are needed to confirm or refute this conclusion. Acupressure may need to be organ-site specific to control CINV.

To compare the effectiveness of immediate-release or sustained-release methylphenidate versus modafinil in improving cognitive function in patients with primary brain tumors.

Patients were randomized to receive one of the following three interventions for a total of four weeks.

• Immediate-release methylphenidate 10 mg twice a day
• Sustained-release methylphenidate 18 mg daily
• Modafinil 200 mg daily

Neurocognitive tests were done prior to the initiation of the intervention and repeated approximately 30 days later after completion of the intervention.

• A total of 24 patients participated in the study.
• Participants' average age was 44.98 years.
• The sample was 54% male and 46% female.
• 62.5% of patients’ tumors were in the left hemisphere.
• Prior treatment history included radiation therapy (83%) and chemotherapy (87.5%). A total of 62.5% were receiving chemotherapy during the study.
   

• Single site 
• Outpatient 
• University of Texas M.D. Anderson Cancer Center in Houston

Patients were in mutliple phases of care.

The study was conducted as a randomized clinical trial.

Objective Cognitive Function Instruments

• Wechsler Adult Intelligence Scale III (WAISIII)—digit span and digit symbol
• Trail Making Test—parts A and B
• Hopkins Verbal Learning Test (HVLT)—immediate recall, delayed recall, and delayed recognition
• Multilingual Aphasia Examination (MAE)—controlled oral word association (COWA)
• Lafayette Grooved Pegboard

Subjective Anxiety Instruments

• State-Trait Anxiety Inventory (STAI)—state and trait anxiety  
• Profile of Mood States (POMS)—tension-anxiety

Subjective Depression Instruments

• Beck Depression Inventory (BDI)
• Profile of Mood States (POMS)—depression-dejection

Subjective Fatigue Instruments

• Brief Fatigue Inventory (BFI)
• Profile of Mood States (POMS)—fatigue

Subjective Sleep-Wake Disturbance Instrument

• Brief Sleep Disturbance Scale (BSDS)

In regards to cognitive function, no differences were found over time with either stimulant in attention or motor function. Mixed results were found over time with stimulant use in speed of processing: significant improvement was found with the WAISIII digit symbol test (p = 0.02), but not with TMT-A. Similarly, a significant decline was found in memory as measured by the delayed recognition subtest of the HVLT (p = 0.03), but not with other subtests of that measure. When evaluating any stimulant use over time in regard to executive function, a significant improvement was found as measured by the TMT-B (p = 0.02) but a significant decline was found as measured by the COWA (p = 0.02). When evaluating differences between the methylphenidate and modafinil treatment groups over time, a significant difference was found in attention (p = 0.05): patients on methylphenidate had stable scores as measured by the digit span test and those on modafinil had worse scores over time. Likewise, a difference was seen in speed of processing (only as measured by the TMT-A) that found patients on modafinil improved in comparison to patients on methylphenidate, who either remained stable or had slight declines (p = 0.05)

In subjective measures of other symptoms, significant improvement was found over time with any stimulant use in depression as measured by the BDI (p < 0.01) and the POMS-Depr (p < 0.01), fatigue as measured by the BFI (p = 0.04) and POMS-fatigue (p < 0.01), and anxiety as measured by the STAI-state (p = 0.03). In contrast, no differences were seen over time for sleep-wake disturbances. No differences were found between treatment groups in subjective symptom measures over time.

Although the study found some improvements in specific cognitive domains over time (e.g., executive function, speed of processing), it is unclear whether these improvements were because of the use of a stimulant, a specific medication (modafinil versus methylphenidate), or other variables such as practice effects (related to the absence of alternative forms for neuropsychological tests). It is difficult to make any definitive interpretations based on this small study, because findings are confounded by the use of two different stimulants (one with two different dosing schedules) and the lack of a control group (patients who were not receiving stimulants).

• The sample size was small with less than 30 participants.
• The lack of a control group introduced a risk of bias.
• The key sample group had differences that could influence the results.
  • The study was unable to meet the sample size recommended by power analysis because of poor accrual and a substantial dropout rate (29%). 
  • The treatment groups varied significantly in age (p = 0.02) and gender (p = 0.03), both of these characteristics are known to influence neuropsychological test results.
• More than 10% of subjects withdrew from the study.

The study does not provide any support at this time to recommend the use of stimulants to improve cognitive function. Future research studies with larger sample sizes and randomized clinical trials with a nonintervention arm are warranted.

To compare the effectiveness of immediate-release and sustained-release methylphenidate versus modafinil in improving cognitive function in patients with primary brain tumors.

Patients were randomized to receive one of the following three interventions for a total of four weeks:  immediate-release methylphenidate, 10 mg twice daily; sustained-release methylphenidate, 18 mg daily; or modafinil, 200 mg daily. Neurocognitive tests were performed prior to the intervention and were repeated approximately 30 days later, after completion of the intervention.

• Twenty-four patients with primary brain tumors were included.
• Mean age was 44.98 years.
• The sample was 54% male and 46% female.
• Most (62.5%) of patients’ tumors were in the left hemisphere.
• Prior treatment history included radiation therapy (83%) and chemotherapy (87.5%). Of all the participants, 62.5% received chemotherapy during the study.

• Single site
• Outpatient
• MD Anderson Cancer Center, Houston, Texas

Patients were undergoing multiple phases of care.

The study was a randomized, clinical trial.

Objective Cognitive Function Instruments

• Wechsler Adult Intelligence Scale, third edition (WAIS-III) Digit Span and Digit Symbol subtests
• Trail Making Test (TMT) Parts A and B
• Hopkins Verbal Learning Test (HVLT) Immediate Recall, Delayed Recall, and Delayed Recognition Trials
• Multilingual Aphasia Examination Controlled Oral Word Association (MAE COWA) category
• Lafayette Instrument Grooved Pegboard Test

Subjective Anxiety Instruments

• State-Trait Anxiety Inventory (STAI) to measure state and trait anxiety  
• Profile of Mood States (POMS) to measure tension and anxiety

Subjective Depression Instruments

• Beck Depression Inventory (BDI)
• Profile of Mood States (POMS) Questionnaire, Depression-Dejection Scale

Subjective Fatigue Instruments

• Brief Fatigue Inventory (BFI)
• POMS questionnaire, Fatigue-Inertia Scale

Subjective Sleep-Wake Disturbance Instrument

• Brief Sleep Disturbance Scale (BSDS)

• Over time, no differences were found in cognitive function in regard to attention or motor function.
• Over time, mixed results were found in regard to the speed of processing:
  • The WAIS-III Digit Symbol subtest showed significant improvement (p = 0.02), but TMT Part A did not.
  • The HVLT Delayed Recognition Trial showed a signficiant decline (p = 0.03) in memory, but the other memory-related trials did not.
• In regard to the use of either stimulant and executive function over time, the TMT Part B score improved significantly (p = 0.02); however, the MAE COWA score declined significantly (p = 0.02).
• In regard to differences between the methylphenidate and modafinil treatment groups over time, researchers found the following:
  • A significant difference (p = 0.05) in attention. Attention-related scores of patients taking methylphenidate were stable on the WAIS-III Digit Span subtest; the scores of patients taking modafinil worsened over time.
  • A difference in the speed of processing as measured by TMT Part A. Patients using modafinil improved in comparison to patients taking methylphenidate, whose scores either remained stable or declined slightly (p = 0.05).
• In regard to subjective measures of other symptoms, researchers noted, with use of either stimulant over time:
  • Significant improvement (p < 0.01) of depression, as measured by the BDI and POMS Depression-Dejection Scale.
  • Significant improvement (p = 0.04) of fatigue, as measured by the BFI.
  • Significant improvement of fatigue (p < 0.01), as measured by the POMS Fatigue-Inertia Scale.
  • Significant improvement (p = 0.03) of anxiety, as measured by the state subtest of the STAI.
• No differences were found over time in regard to sleep-wake disturbances.
• No differences were found between treatment groups in subjective symptom measures over time.

Although this study revealed some improvements in specific cognitive domains over time (e.g., executive function, speed of processing), it is unclear whether these improvements were due to the use of a stimulant; a specific medication (modafinil versus methylphenidate); or other variables, such as practice effects related to the absence of alternative neuropsychological tests. Making definitive interpretations based on this small study is difficult because the findings were confounded by the use of two stimulants (one with two different dosage schedules) and the lack of a control group (patients who were not receiving stimulants).

• The study had a small sample size, with less than 30 participants.
• The study had risks of bias due to no control group and no blinding.
• Participant withdrawals were 10% or greater.
• The investigators were unable to achieve the sample size recommended by the power analysis due to poor accrual and a high drop-out rate (29%). Treatment groups differed significantly in regard to age (p = 0.02) and gender (p = 0.03). Age and gender influence neuropsychological test results.

No evidence was provided to support the use of stimulants to improve cognitive function. The study supports the conduct of future research of this topic in studies with larger sample sizes and in randomized, clinical trials with a nonintervention arm.

The study was conducted to evaluate the effectiveness of a multifaceted cognitive rehabilitation program's (CRP's) measures of cognitive functioning in patients with gliomas whose disease was in remission.

An eligibility screening was conducted through

1. Telephone interviews confirming at least one cognitive symptom from the Medical Outcomes Study Cognitive Functioning Scale among individuals who expressed an interest in CRP participation.
2. Objective neuropsychological assessment, in which participants performed at least one standard deviation below a healthy comparison group's mean (n = 294) on at least 4 of 20 neuropsychological assessment variables.

The randomization procedure was a minimization method balancing age, sex, education, tumor grade, hemisphere, radiotherapy, neurosurgery, disease duration, and institution.

The control group received standard care without cognitive intervention, and had contact with research staff at similar intervals as the intervention group. Control participants received a telephone-based empathy session during which attention to possible cognitive problems occurred without the provision of advice. At the study's completion, control participants were offered the opportunity to receive the intervention.

The intervention group received six weekly individual sessions of two hours each, carried out by seven neuropsychologists. Two techniques were incorporated. 

1. Cognitive retraining using a computer program (C-Car) consisting of a series of hierarchically graded tasks designed to strengthen various aspects of attention on the basis of patients needs.
2. Compensatory training consisting of six psychoeducational sessions on attention, memory, and executive function. This training included didactic and practical elements aimed to help patients compensate for impaired cognitive function.

• All participants had glioma in remission.
• The total number of participants was 140, with 70 patients each in the treatment group and control group.
• The average participant age was 42 ± 9.4 years for the treatment group.
• The average participant age was 43.8 ± 10.5 years for the control group.
• The treatment group was 58.6% male and 41.4% female.
• The control group was 57.1% male and 42.9% female.
• The median number of years since treatment was 2.6 years for the treatment group.
• The median number of years since treatment was 3.1 years for the control group. 

Patients were recruited from 11 Dutch hospitals, including 10 neurosurgical centers.

The study utilized a randomized, controlled trial.

• Dutch Adult Reading Test (DART) and the Drie-Minuten-Toets Three Minute Test (DMT) for premorbid intelligence
• Stroop Color-Word Test (SCWT), Digit Span (Forward and Backward), Memory Scanning Test (MST), and the Test of Everyday Attention (TEA) for attention
• Multidimensional Fatigue Inventory (MFI) for mental fatigue, activity, and motivation
• Community Intervention Questionnaire (CIQ) for home integration, social integration, and productivity
• Visual Verbal Learning Test (VVLT) for memory
• Concept Shifting Test (CST), Letter Fluency (LF), and Category Fluency (CF) for executive function
• Medical Outcomes Study Cognitive Functioning Scale
• Cognitive Failure Questionnaire (CFQ)
• Behavioral Assessment of Dysexecutive Syndrome (BADS)

Eighty percent of CRP subjects reported that the intervention addressed their problems; 87% used compensation strategies regularly, and 79% indicated a decrease in the impact of cognitive problems on daily functioning. The intervention group had significantly better combined attention scores (in four out of seven tests) than the control group (p = 0.004) at the six-month follow-up. Verbal memory and attention were improved for the intervention group at the six-month follow-up, suggesting the intervention's success with some sustainment in learned skills.

Effect sizes for the CRP ranged from 0.23 to 0.55. The intervention group had significantly better combined scores on verbal memory tests than the control group (p = 0.009). Effect sizes for the intervention group on two of three tests were 0.48 and 0.43. Mental fatigue on the MFI was improved in the intervention group at the six-month follow-up (p = 0.044), with an effect size of 0.41.

Self-reported cognitive function (CFS, CFQ, burden) was better in the intervention group on completion of the CRP (p = 0.001). Effect sizes ranged from 0.31 to 0.48. However, at the six-month follow-up this improvement was maintained, while the control group continued to improve.

There were no significant differences between groups on neuropsychiatric assessment scores at baseline. There were no statistically significant group differences in attention or verbal memory scores at completion of the CRP.

CRP was useful in improving cognitive function, with sustained improvements in verbal memory and attention over time.

• Mild cognitive impairment was detected by baseline cognitive function scores in the majority of subjects, which could impact the expected change from the CRP intervention (ceiling effect).
• The study did not indicate whether hemispheric location of the tumor influenced cognitive functioning.
• The authors did not specify whether they controlled for tumor characteristics, seizure frequency, and use of anti-epileptics in the analyses.

LITERATURE EVALUATED: Studies were independently evaluated by two reviewers for quality using the checklists from the Dutch Cochrane center with a 1, 0, or ? (1 = if sufficient information was available and no likelihood of bias, 0 = sufficient information but missing a criterion, ? = no information available). No meta-analysis was done.

• FINAL NUMBER STUDIES INCLUDED = 27 studies
• TOTAL PATIENTS INCLUDED IN REVIEW = The number of patients was not provided for every article, so based on information provided, N = 959. Pooled results: ALND = 1,184, sentinel lymph node biopsy (SLNB) = 1,507
• SAMPLE RANGE ACROSS STUDIES: 20–360 patients
• KEY SAMPLE CHARACTERISTICS: Patient characteristics, ARM methodology, ARM feasibility (% on nodes found, % ARM crossover, tumor cells in ARM), assessment, definition, and incidence of lymphedema

PHASE OF CARE: Diagnostic

A total of 27 studies were systematically reviewed for content on the type of ARM, its safety, and whether it decreased the incidence of lymphedema. Three ARM procedures were described: (a) dermally injected blue dye, (b) injected radioisotope Tc-99m Nanocoll with subsequent lymphoscintigraphy, and (c) lymphofluoroscopic assessment using an intradermal injection of indocyanine green (ICG). The ARM detection rate was less in the sentinel lymph node biopsy (SLNB) cases (19.9%–100% with 100% representing one sample) than the ALND cases (46.6%–94.9%). Crossover nodes (those representing ARM and sentinel nodes) were identified in 5.6%–20% of ALND cases and 0%–14% of SLN cases. The recurrence of cancer in nodes that were ARM preserved would determine oncologic safety, in which studies from a referenced source deemed the ARM procedure as oncologically safe in clinically node negative, SLN positive cases, with the exception of the ARM and positive SLN being synonymous. The incidence of lymphedema reported for all ALND cases was 0%–30% and for all SLNB was 0%–4%. Lymphedema ranges for non-ARM ALND cases was 11.8%–53.5% and for SLN samples was 0%–15.8%.

• Limited search
• Low sample sizes
• Lymphedema definition varied
• Method of lymphedema measurement varied
• Level of evidence for all studies except one RCT was low.
• Oncologic safety was based on one source.
• No information about the patient population and medical characteristics
• Four indices were used for search.

The implications for nursing would be in the area of patient education, if and when the ARM procedure becomes a standard of care. For the present, nurses need to be knowledgeable of clinical trials involving ARM.

To evaluate the therapeutic effects of a low level He-Ne laser on chemoradiation (CRT) -induced oral mucositis (OM), associated severe pain, and use of total parenteral nutrition (TPN) in patients with oral cancer

Block randomization was done using a computerized program taking primary oral cancer stage as a matching variable of 121 primary patients with oral cancer scheduled to undergo CRT (RT dosage = 66 Gray/33 fractions for five days per week and chemotherapy was three weeks cisplatin). Patients were randomized to either laser (n = 60) or placebo (n = 61). Both groups received standard oral care and hygiene. Patients and outcomes assessor were kept blinded for the laser intervention. OM, its associated pain, and TPN were assessed every week by a blinded assessor. Opioid analgesic use, weight loss, and any CRT breaks were recorded.   

Laser treatments used He-Ne 632.8 nm, power output of 24 mW, beam spot diameter of 0.6 mm, noncontact method (Technomed Electronics, Advanced Laser Therapy 1000, Chennai, India). This was applied to the anatomical sites in the oral cavity (buccal mucosa, lateral and ventral tongue, labial mucosa, floor of the mouth and palate), excluding cancer site daily just before radiation session for 6.5 weeks.

The placebo group received sham therapy (the probe was kept off, and there was only a beep sound) just before radiation for 6.5 weeks. 

• The study reported on 121 patients with cancer of the oral cavity.
• The mean age of patients in the laser group was 51.71 years, and the mean age of patients in the placebo group was 52.60 years.
• The sample was 91% male and 9% female.

This was a single-site study in a nonspecified setting in India.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for end of life and palliative care.

This was a prospective double blinded, randomized controlled trial.

• An experienced radiology oncologist who was blinded for the intervention group performed the assessment of the oral mucositis using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring system (grade 0–4).
• The need for TPN was recorded at the end of every week.
• Opioid analgesics use, weight less, CRT break during severe oral mucositis (grade > 2), and pain severity (using a visual analog scale [VAS]) of greater than 7 were recorded.

During the last weeks of CRT, incidence of mucositis greater than grade 2 was less in the laser group than in the placebo group (p < 0.0001). The mean duration of severe grades of OM was less than in the placebo group.

At the third week of CRT, no statistical difference was found between groups for incidence of OM, severe pain, TPN, and weight loss.

The laser group had less need for opioid use (p < 0.001). None of the patients in the laser group required a break in CRT, but 9% of patients in the placebo group required a break in CRT.

OM progressed at a slower rate in the laser group than in the placebo group. Pain was less severe as rated by pain scores, and TPN was significantly less in the laser group than in the placebo group.

Low level He-Ne laser was found to decrease the incidence of CRT-induced, severe OM and its associated pain; opioid analgesic use; and TPN for patients with oral cancer.

Low level helium neon laser therapy for the reduction of chemotherapy-induced OM in patients with oral cancer appears to be helpful, but the therapy is limited because of the need for the laser and an experienced laser therapist. The laser therapy in this study included standard oral care and hygiene; therefore, laser therapy does not eliminate this need.

Long-term follow-up on the effects of laser on OM is recommended to understand the carryover effects of laser in these patients. Studies explaining the exact mechanisms of action of laser also are recommended.

To examine the efficacy of low level laser therapy (LLLT) in patients with head and neck cancer receiving chemotherapy and radiation therapy (RT)

Patients were randomly assigned to receive LLLT or sham treatment. Both groups received standard oral care and oral hygiene protocol, including frequent mouth washes with sodium bicarbonate. Patients in the LLLT group were treated with helium neon laser in 15–20 minute sessions, five sessions per week, at six anatomical sites in the oral cavity. Treatment was done daily prior to RT for 45 days. Patients, outcomes assessors, and statisticians were blinded to patient group assignment. Oral mucositis was assessed and graded daily.

• The study reported on 221 patients with a mean age of 55.4 years (SD = 11.4 years).
• The sample was 85.5% male and 14.5% female.
• All patients were newly diagnosed and receiving 100 m/m² cisplatin on days 1, 22, and 43 and 66 Gy radiation in 33 fractions, five days per week.
• All had stage 3 or 4 disease.  

This was a single-site, outpatient study conducted in India.

Patients were undergoing the active antitumor treatment phase of care.

The study design was a randomized triple-blind sham-controlled randomized clinical trial.

• The European Organization for Research and Treatment of Cancer (EORTC) mucositis scoring system was used.
• The need for supplemental analgesics and parenteral nutrition was recorded.
• A visual analog scale was used to measure pain.

• Oral mucositis increased in both groups over time, but progressed more slowly in the laser group (p < 0.0001).
• At the end of treatment, incidence of grade 3–4 mucositis was about three times lower in the laser group.
• Duration of severe mucositis was less with the laser group.
• The average number of RT fractions after which severe mucositis developed was higher in the laser group. 
• Average pain scores were consistently lower in the laser group (p < 0.00001).
• The need for total parenteral nutrition was lower in the laser group (p < 0.00001). 
• Fewer patients in the laser group required any treatment delays.

Prophylactic LLLT in patients with head and neck cancer receiving concomitant radiation and chemotherapy was effective in reducing the incidence of severe oral mucositis.

Without a longer-term follow up, long-term effects of LLT are not known.

Prophylactic use of LLLT was able to prevent and treat severe oral mucositis in this group of patients. This study adds to the growing body of evidence supporting the effectiveness of LLLT in patients with head and neck cancer receiving treatment, particularly in patients receiving chemotherapy with RT. Nurses can advocate for the use of LLLT in this patient population.