To determine the efficacy of a mouthwash solution composed of verbascoside, polyvinylpyrrolidone, and sodium haluronate (Mucosyte) in the treatment of chemotherapy-induced oral mucositis (OM)

Patients undergoing chemotherapy for acute lymphoblastic leukemia (ALL) on the same protocol treatment (ALL 2009 standard protocol) were included in the study. Patients were randomized to either the group A (intervention group) or group B (placebo group). Each group were to rinse with 15 ml of the solution for two minutes three times a day for a total of eight days. OM scoring was conducted on day 1 (day of diagnosis of OM), three days after treatment, and again on day 8. Pain scores were determined at the same time as the oral examination for the OM scoring.

• N = 56   
• AGE = 5–18 years
• MALES: 9 (intervention), 13 (placebo), total = 39%  
• FEMALES: 19 (intervention), 15 (placebo), total = 61%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: ALL
• OTHER KEY SAMPLE CHARACTERISTICS: Grade 1 or 2 OM

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Italy

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Randomized, double-blinded study. Each participant was randomized with an automatically generated list.

• Common Toxicity Criteria for Adverse Events (CTCAE) and scale of the WHO to grade OM
• Visual analog scale (VAS) used to score pain level

Group A showed a reduction in OM of T1 on day 3. On day 8, group A and group B had a reduction of T2, with group A revealing a statistically significant decline compared to group B (p = 0.0038). Group A showed a reduction in pain scores for both TI and T2, resulting in a reduction in additional analgesia needed, compared to group B.

The use of Mucosyte mouthwash in children with chemotherapy-induced OM revealed a reduction in the grade of OM and pain scores during an eight-day treatment and, therefore, may be recommended as a supportive treatment.

Small sample (< 100)

The implications of this study are promising for treatment with Mucosyte mouthwash for reducing OM and pain during chemotherapy for ALL. More studies may need to be conducted, because this study took into account only patients on the same treatment regimen. Other treatment regimens including chemotherapy, radiation, and or laser therapy may affect the severity and duration of OM and, therefore, may reveal different results.

To assess the effectiveness of self-massage and skin care using a base cream containing aromatherapy oils versus using a base cream without aromatherapy oils in terms of objective reduction in limb volume and patient-reported symptom improvement and well-being after simple lymphatic drainage

• The sample (N = 81) was comprised of patients who were randomized to either the experimental group (n = 40) or the control group (n = 41).
• The majority of patients were female (n = 77), with only four male patients.
• Age of the sample ranged from 25–80 years.
• Patients were included in the study if they
  • Were referred to the Dorset Cancer Centre Lymphedema Service
  • Had lymphedema for more than one year
  • Had bilateral or unilateral stable lymphedema
  • Had no evidence of acute inflammation, thrombosis, or recurrence
  • Agreed to avoid other aromatherapy-based treatments and products during their treatment period
  • Were not pregnant or sensitive to aromatherapy or wheat germ.

• Circumference was measured every 4 cm using a self-tensioning tape measure and recorded as absolute volume.
• Truncated cone calculation was used to calculate volume.
• Measurements were taken monthly for three months.
• If no improvement was seen over three months, patients were taken off the trial and returned to standard hospital therapy.
• Symptom improvement, activity, and well-being were measured using the Measure Yourself Medical Outcome Profile 2 (MYMOP2).

Self-massage and skin care significantly improved patient-identified symptom relief and well-being for patients. It also, but not significantly, reduced limb volume. Aromatherapy oils did not appear to influence any improvement in these measures. In the experimental group, 69% had limb reduction, compared to 57% in the control group (p = 0.38). Both groups combined showed slight improvement (p = 0.034). The finding supports the use of simple lymphatic drainage. Well-being, pain, discomfort, mobility, and body image were evaluated and showed significant improvement in patient-identified symptom relief and well-being. No difference was observed using aromatherapy.

• Determining the value of subjective benefits was difficult, even using the scale.
• The study used both primary and secondary patients.
• The study sample was not a very homogeneous group, presenting too many variables.
• Patients did not necessarily have a cancer diagnosis.
• The cause of lymphedema was not defined.

RCT was designed to evaluate pain control and the ability to eat and drink using standard therapy (sucralfate and Mucaine® [Wyeth-Ayerst Laboratories]) versus Gelclair®  (EKR Therapeutics, Inc.) in patients with radiotherapy-induced oral mucositis.

Patients used medication 30 minutes to 1 hour before eating or drinking.

Gelclair: Patients used undiluted or could mix a single dose in a glass with up to 40 ml of water. Patients swished and gargled for at least one minute to coat the tongue, roof of mouth, throat, and inside of cheeks. If unable to do that, patients used sponge applicators. Patients spat the product out and did not swallow it.

Sucralfate and Mucaine: Patients swished 10 ml in mouth for at least 1 minute to coat all areas, then swallowed the product.  

Study was 24 hours only. Baseline was 1, 3, and 24 hours after initiation of treatment.

Patients in both groups had additional analgesia available throughout the trial.

Patients swallowed standard therapy but not Gelclair.

 

The sample was comprised of 20 patients (n = 10 in the Gelclair group and n = 10 in the standard [sucralfate and Mucaine] group).

Patients with head and neck cancer received daily radation therapy over a 4–6 week period and showed at least grade 1 oral mucositis and pain not alleviated by paracetamol, co-codamol, or aspirin.

The mean age was 61.1 years (range = 28-79 years).

Three patients were smokers.

 

Double-center, prospective RCT

Single blind trial with the administrating nurse specialist unaware of medication used

Conducted as feasibility study for future sample size calculation

Oral mucositis NCI-CTC for radiation

General pain and pain on speaking VAS 0–10

Swallowing assessment was self-recorded (normal to swallowing own saliva only).

Compliance was queried by the researcher.
 

Using NCI grading, nine patients had grade 3 or 4 (three in the intervention arm and six in the control arm). The remaining 11 patients had grade 1 or 2 (seven in the Gelclair group and four in the standard therapy group).

No observations of relevance with regard to general pain, pain on speaking, or ability to eat and drink for those with higher grades of oral mucositis.

Number of coanalgesics of strong opiate type

One patient was noncompliant for sucralfate and Mucaine.

General pain: No significant difference was observed between the intervention and the control group across time intervals (p = 0.236).

Reduction in pain on speaking was not significant (p = 0.616).

Swallow: Effects of standard therapy appeared to last longer than Gelclair (NS).
 

Because the study was only 24 hours, effectiveness with more severe mucositis is not known.

 

To explore the relationships between adult cancer survivors’ and caregivers’ social support, self-efficacy for physical activity, physical activity, and quality of life, and to understand their perceptions of social support in physical activity participation

Participants attended the FitSTEPS for Life^® (FSFL) for one month. FSFL is an individually tailored and supervised community-based exercise program for cancer survivors and their caregivers established by the Cancer-Foundation For Life nonprofit organization. Survivors required a referral from their oncologists to be able to attend FSFL and were expected to exercise at least three times a week.

Only data on caregivers were included in this summary.

• N = 39 at baseline (eight at follow-up)  
• MEAN AGE = 62.1 years (SD = 13.8 years)
• MALES: 10 (25.6%), FEMALES: 29 (74.4%)
• KEY DISEASE CHARACTERISTICS: Caregivers of patients with various cancers and stages
• OTHER KEY SAMPLE CHARACTERISTICS: Adults; 30 of 39 were Caucasian; 21 of 24 used mobility devices; able to read, write, and comprehend English; paid caregivers were excluded

• SITE: Multi-site    
• SETTING TYPE: Other  
• LOCATION: East Texas and Dallas

• PHASE OF CARE: Late effects and survivorship

Mixed-method, quasi-experimental study with written responses to questions and recorded interviews of the caregivers of patients who enrolled in FSFL based on oncologist referrals

• Quantitative
  • Social Support and Exercise Survey
  • The Exercise Confidence Survey for self-efficacy for physical activity (SEPA)
  • The 8 Foot Up and Go functional fitness test for physical activity (PA) participation
  • Quality of Life Short Form 8 (SF-8)
• Qualitative
  • Written responses to open ended-question “please tell us how social support affects your PA each day” at baseline and one month later; and interviews face to face and on the phone responding to a semistructured interview that were recorded and transcribed verbatim.

Participation in FSLP did not have a significant effect on caregivers' PA, quality of life, social support, or SEPA. Qualitative data supported relationships between social support, PA, and quality of life.

• Small sample (< 30): Only eight caregivers completed the one-month follow-up questionnaire
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Questionable protocol fidelity

Nurses should consider the role of social support in designing interventions to influence the PA, self efficacy, and quality of life of caregivers. Nurses should encourage cancer survivors and their caregivers to openly discuss their needs for social support. This study was too small to evaluate the effects of exercise, and the high drop out rate suggests that continued involvement in this type of effort may not be acceptable for patients and caregivers.

The intervention consisted of once weekly art therapy sessions to teach patients to act in a more conscious way by painting with water-based paints. The intervention was provided by an art therapist. The duration of the sessions varied. Those who completed four or more sessions (n = 19) were compared to those who participated for two weeks or less (n = 41).

• The sample was comprised of 60 adult ambulatory patients (77% female, 23% male) who were undergoing chemotherapy.
• Mean age was 77 years (range 25–72).
• Patients were excluded from the study if they had severe anemia; were treated with an epoetin; had changed their opiate, non-selective serotonin reuptake inhibitor (SSRI) antidepressant, or anxiolytic in the past three weeks; or had changed their SSRI antidepressant in the past six weeks.

The study was conducted in an ambulatory setting of a cancer center in northern Israel.

The study used a single-arm, open-label design.

• Brief Fatigue Inventory (BFI), competed weekly before each session
• Hospital Anxiety and Depression scale (HADS), competed weekly before each session

• Median BFI score decreased from 5.7 to 4.1 in the intervention group (p = 0.24).
• Median HADS decreased from 9 to 7 in the intervention group (p = 0.21); anxiety was normal.

• The control group had greater fatigue and may not have been able to participate.
• The study lacked randomization.
• The study did not provide control data related to patient drop-out or chemotherapy.
• Cycle or day-in-cycle assumptions regarding mediating the effect of decreased emotional distress were untested.

For treatment with art therapy, a patient requires referral to an art therapist.

An anthroposophy art therapy intervention (watercolor painting) in weekly group sessions was administered by an art therapist in northern Israel. Participants chose the amount of time to spend in the session, ranging from a few minutes to more than an hour. Data were collected at baseline and before every session.

• The study reported on a sample of 60 oncology inpatients and outpatients who were receiving chemotherapy, radiotherapy, or follow-up care.
• Patients in the intervention group (n = 19) completed four or more art sessions.
• Patients in the participation group (n = 41) completed one to three art sessions.

A single-arm, pilot study design was used.

• Hospital Anxiety and Depression Scale (HADS)
• Brief Fatigue Inventory (BFI)

A Mann-Whitney U test compared HADS and BFI in the intervention group and the participation group. A Wilcoxon signed-rank test assessed changes in HADS and BFI scores in the two groups. There were no significant difference between the two groups for reducing anxiety (p = 0.2).

• Anxiety levels at baseline were in the normal range for both groups.
• The small sample size of unspecified types of cancer and varying treatments, lack of statistically significant findings, and lack of randomization or control group limited this study.
• A specialized art therapist was needed to administer the intervention.

To observe the clinical effectiveness of a topical application of Xiaozheng Zhitong Paste (XZP) in alleviating the cancerous pain of patients with middle/late-stage cancer

Patients were randomized into either the treatment group (64 patients) or the control group (60 patients). In addition to utilization of three-ladder (3L) analgesia therapy in both groups, topical application of XZP was given to patients in the treatment group for pain alleviation. Analgesic efficacy was recorded in terms of pain intensity, analgesia initiating time and sustaining time, and the optimal analgesic effect revealing time. Quality of life and adverse reactions that occurred in patients were also recorded.

• The study reported on 124 patients.
• Mean patient age in the treatment group was 69 years (range = 58–74 years); mean patient age in the control group was 67 years (range = 56–75 years).
• The treatment group was 56% female and 44% male; the control group was 65% female and 35% male.
• Patients estimated their pain degree by the verbal rating scale (VRS) as greater than 4; had received 3L analgesia without adequate control, and required an increase or change in dosing. The pain was localized, with the number of pain sites being less than four, and suitable for external compression with no skin damage, edema, or heat.
• Patients were older than age 18, had no allergy history, had no psychiatric illness, had normal language expression, and were able to self-report.

• Inpatient oncology
• Department of oncology, Guang’anmen Hospital

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

The extent of pain, the analgesic effect initiating time and sustaining time of medication, and the optimal effect revealing time were recorded before medication and 24 hours after medication. Quality of life was estimated by Karnofsky scoring and the Brief Pain Inventory (BPI).

Intensity of pain was evaluated per standards of the World Health Organization with the numeric rating scale (NRS), expressed as digits from 0–10 (0 for no pain, 10 for extreme pain). Intensity of pain was ranked into four grades: 0 = no pain; grade I = endurable pain, normal daily life, sleep not affected, NRS 1–3; grade II = obvious pain, unendurable, patients asked for analgesia, daily life and sleep affected, NRS 4–6; grade III = severe pain, could hardly endure, analgesia necessary, sleep interfered with, impact on motion, forced posture, painful complexion, and incessant groaning, NRS 7– 10.

Effectiveness on pain treatment was classified into four grades: completely remitted (CR), partially remitted (PR), mildly remitted (MR), and no palliation (NP). Comparison of the total effective rate (sum of CR+PR+MR) between the two groups showed no significant difference (p > 0.05). Analgesic effect initiating time was decreased, and its sustaining time was elongated in both groups after medication (p < 0.01), but the initiating time was shorter in the treatment group than in the control group (p < 0.01). The mean optimal analgesia effect was shorter in the treatment group, demonstrating a significant difference (p < 0.01).

Compared by the effect of pain on patients, the effect was attenuated by both groups after medication, but the mental condition, walking capacity, social acceptability, sleep, and joy of living were all better with those in the control group, showing statistical significance (p < 0.01).

The combination of 3L analgesia and XZP compress demonstrates the similar effects in pain alleviation as compared with 3L analgesia alone.

XZP paste was prepared at the pharmaceutical department of the author’s hospital.

Chinese medicine may prove to be beneficial for patients with cancer-associated pain management issues, as well as in end-of-life and palliative care; however, these findings do not provide support for the intervention tested here. Nursing participation in these evaluations is essential.

To compare the analgesic effect of applying magnetic acupressure to the L14 point to that of applying magnetic acupressure to a sham point

Patients were stratified by the number of prior bone marrow aspiration biopsies (BMABs) and randomized to one of two groups. In the first group, a practitioner delivered acupressure to the L14 acupoint (the dorsum of the first interosseus space of the hand). In the second group, a practitioner delivered acupressure to a sham point (the fourth interosseus space of the hand). Two HACI magnetic acupressure suction cups (HMASCs) were applied to the designated area of both the patient's hands for the duration of the BMAB procedure. The same two HMASCs were used on all study patients. All patients received standard local analgesics as ordered by the BMAB provider. The same BMAB provider and acupressure practitioner were used throughout the study. The patient, BMAB provider, and outcome evaluator were blinded to the location of the acupressure. The patient’s pain intensity was measured at baseline and after the BMAB.

• The sample was composed of 77 patients, 37 in the L14 group and 40 in the sham-point group.
• Mean patient age, in both groups, was 57 years (SD = 12.4 years).
• Of all patients, 61% were  male and 39% were female.
• Authors did not cite disease characteristics.
• Of all patients, 82% were Caucasian (authors noted no other races). Of the L14 group, 31% had had more than one BMAB; of the sham-point group, 75% had had more than one BMAB.

• Single site
• Inpatient and outpatient
• Locations associated with the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore
   

Multiple phases of care

Single-center randomized single-blind clinical trial

• Visual analog scale (VAS) of 11 points, to measure baseline pain score and score post-BMAB (The patient was asked to rank the worst pain experienced during BMAB.)    
• Measures of the use of analgesic or anxiolytic medications in the 12 hours preceding the BMAB (Data were gathered by means of questioning patients.)
• Post-BMAB data reflecting patients' opinions about the effectiveness of the acupressure in pain relief
• Measures of acupressure side effects

Authors noted no significant difference in median pain scores between the patients treated at the L14 site versus the sham site (3.0 versus 3.0, p = 0.08, Mann-Whitney test). Eight patients (20%) in the sham-site group experienced severe pain. One patient (2.7%) in the L14 group experienced severe pain (p = 0.03, two-tailed Fisher’s exact test). The unadjusted risk of patients experiencing severe pain in the sham-site group was nine times higher (95% CI 1.07–75.9, p = 0.04). After accounting for age, number of prior BMABs, baseline pain scores, and the number of times the cup fell during the procedure, patients in the sham-site group were more likely to experience severe pain than were those in the L14 group (risk ratio 9.3; 95% CI 1.01–85.6; p = 0.049). The acupressure point was the only statistically significant factor associated with BMAB-related pain.

Magnetic acupressure delivered at L14 may reduce the number of patients who experience severe pain during BMAB.

• The study had a small sample, with fewer than 100 participants.
• Generalizability of findings is limited because data were collected at only one study site and by only one BMAB operator and because one acupressure practitioner delivered the study procedure. In addition, pain was measured after the procedure rather than during the procedure. When this measurement occurred is unclear.

The combination of magnetic acupressure at the L14 site and local anesthetics may reduce severe pain during BMAB. Acupressure is inexpensive, and it requires minimal training to deliver.

To determine the effectiveness, safety, and convenience of acupuncture in decreasing bortezomib-induced peripheral neuropathy (BIPN)

Patients were treated with 10 acupuncture treatments twice a week for two weeks, then once a week for four weeks, and then every other week for four weeks. Patients remained on their prescription PN medications.

• N = 20  
• MEDIAN AGE = 63 years
• AGE RANGE = 49–77 years
• MALES (%): Not stated, FEMALES (%): Not stated
• KEY DISEASE CHARACTERISTICS: Multiple myeloma 
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had received bortezomib 1–83 months ago, had continuing BIPN (grade 2 or greater), and were taking various medications for it, such as gabapentin, narcotics, amitriptyline, pregabalin, and duloxetine.

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: University of Maryland Greenebaum Cancer Center

PHASE OF CARE: Active antitumor treatment

Prospective study

• Clinical total neuropathy score
• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)
• Neurotoxicity questionnaire
• Neuropathy pain scale (NPS)
• Serum cytokines were drawn for correlative studies.

The Clinical Total Neuropathy Score was considered invalid because of reliability and validity issues in this setting. The FACT/GOG Neurotoxicity (Ntx) subscale and NPS scores demonstrated significant decreases in BIPN symptoms. Improvements in buttoning and walking at weeks 10 and 14 (p values < 0.0001) were observed. No differences in nerve conduction evaluations were reported from baseline to the completion of the study. No change in serum biomarkers were reported.

Acupuncture was demonstrated as a safe although inconvenient treatment for BIPN. Patients reported improvements in BIPN symptoms.

• Small sample ( <30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

The intervention produced a decrease in some BIPN symptoms. Acupuncture needs to be administered by a licensed therapist, which may not be a realistic treatment for all patients. A large, randomized trial is indicated for future research.

To evaluate the effect of acupuncture on function and pain in women with aromatase inhibitor associated musculoskeletal symptoms (AIMSS) and the effect of serum hormones and proinflammatory cytokines to help clarify the molecular mechanism of action with the use of acupuncture

Patients were randomized to eight weekly real or sham acupuncture sessions evaluated by the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scare (VAS) at baseline and after intervention. Serum hormones and proinflammatory cytokines were measured pre- and post-intervention.

• N = 47  
• AGE = 44–85 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Postmenopausal women with stage 0–III breast cancer that was estrogen-receptor-positive or progesterone-receptor-positive receiving a standard dose of a third-generation aromatase inhibitor for one month or longer and with documented AIMSS. Baseline HAQ-DI or pain using a 100-point VAS of 20 or more
• EXCLUSION CRITERIA: Acupuncture treatment within the past 12 months

• SITE: Multi-site 
• SETTING TYPE: Not specified; outpatient
• LOCATION: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; the University of Maryland Greenebaum Cancer Center

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care

• Randomized, controlled double-blind trial

• HAQ-DI
• Pain VAS

No significant difference was seen in HAQ-DI and VAS scores between the groups. A significant reduction of interleukin 17 was seen in both groups after eight weeks, and no significant changes were seen in other hormone/proinflammatory markers in either group. No significant difference were seen in AIMSS between the groups; however, after eight weeks of  treatment, HAQ-DI and VAS scores improved for both groups.

This study does not appear to support acupuncture as a means to reduce musculoskeletal symptoms in patients with breast cancer taking aromatase inhibitors. Sham and real acupuncture seem to improve HAQ-DI and VAS scores and seem to lower baseline, as revealed by a 12-week follow-up after the study. Neither acupuncture nor sham acupuncture produced any adverse effects and seem to be safe as an option for patients with early-stage breast cancer with AIMSS.

• Small sample (less than 100)
• Findings not generalizable
• The sample size limits the ability to generalize findings.
• Acupuncture training is required to perform the intervention.

This study does not support acupuncture over sham acupuncture for the treatment of AIMSS in women with early-stage breast cancer. That being said, acupuncture has helped to improve VAS and HAQ-DI scores, suggesting it as a positive intervention with no side effects for these patients. Education and training in acupuncture would be suggested prior to therapy, but this article suggests that sham acupuncture produces statistically similar results and improves scores.