To determine if a specified pain management program for cancer patients is associated with pain reduction, an increase in pain medication, and a reduction in barriers to pain management

Participants were assigned to an experimental group or a control group. Each group received routine pain management education, including a one-page pamphlet about pain and the use of pharmacotherapeutics and nonpharmacotherapeutic pain relief methods.  Follow-up sessions of approximately 15 minutes each occurred on days 3 and 5. Follow-up sessions included pain assessment and reinforcement of information from the booklet. The experimental pain management program included a 30-minute individual education session and follow-up sessions on days 3 and 5. On follow-up days pain was assessed and education and management methods reinforced.

• The sample was composed of 38 patients.
• In the experimental group, mean patient age was 61.96 years. In the control group, mean patient age was 63.94 years.
• Of all patients, 60% (24 patients) were male; 13 men were in the experimental group and 11 men were in the control group. Of all patients, 40% (14 patients) were female; 7 women were in each group.
• The sample included various cancers, including breast, bone, lung, gastrointestinal, genitourinary, and skin cancers, with and without metastases.
• At baseline, pain intensity in the experimental group was 4.7; in the control, 4.2. All participants took analgesics regularly to relieve pain, and 60% used nonpharmacologic methods to control pain. Length of stay was seven days.

• Single site
• Inpatient
• Palliative care and hospice ward, Hong Kong
   

• Phase of care: end-of-life care
• Clinical applications: end-of-life care and palliative care

Prospective randomized controlled trial with pre/post-test

• Numeric Rating Scale, a Likert-type self-report
• Barriers Questionnaire-Taiwan (BQT), which offered an internal consistency of 0.89 and a test-retest reliability of 0.90
• Record Sheet for PRN Analgesic (a component of the medical record)
• Spreadsheetlike record of nonanalgesic methods (spreadsheet maintained by researcher)
• Paired t-test for within group and independent t-test for comparison between experimental and control groups

• At baseline and after day 7, authors observed no significant difference between control group and experimental group in regard to pain (P > 0.05). However, in terms of frequency, the experimental group used significantly more analgesics and more nonpharmacologic strategies (P > 0.05). The group that received the pain management program (PMP) increased use of nonpharmacologic strategies (p < 0.05, mean = 0.75 [SD = 0.72]). Authors noted significant post-PMP differences in analgesic use (p < 0.05), with more analgesics used in the PMP group (analgesics mean = 1.15 [SD = 0.81]).  
• BQT results reflected a significant change (P < 0.05) in the experimental group in six of eight measures. The change could mean that participants felt more empowered in their handling of pain and use of pharmacologic and nonpharmacologic pain strategies.
• The pain scores of both groups decreased, although authors noted no significant difference between the decrease in each group (P > 0.05). However, the experimental group significantly increased its use of analgesics and nonpharmacologic strategies and reduced barriers to pain management.

Development and implementation of a pain management education program directed at reducing patient barriers and misconceptions about pharmacologic and nonpharmacologic strategies may help increase a patient's sense of empowerment regarding pain management.

• The study had a small sample, with fewer than 100 patients. Authors did not cite a power analysis of sample size.
• Analgesic dosing was not consistently tracked and recorded.
   

Pain education for patients is recommended.

To investigate the effects of foot reflexology on pain and anxiety in patients undergoing surgery for digestive cancer

Patients were randomly assigned to the intervention group or a control group that received usual care. The intervention consisted of 20 minutes of foot reflexology using a standard protocol. A nurse certified to deliver this treatment provided it on day 2 after surgery, between one and three hours after the patient had received a dose of pain medication. Pain and anxiety were assessed at baseline and on postoperative day 5. A research assistant blinded to the randomization collected data. In the intervention group, pain was assessed before and after the intervention.

• The sample was composed of 62 patients.
• Mean patient age was 59.8 years (SD = 14.7 years).
• Of all patients, 52.5% were female and 47.5% were male.
• Patients had hepatocellular and gastric cancer. The types of surgeries performed were gastrectomy, hepatic lobectomy, or segmentectomy.
• Of all patients, 77% were married and 54% had more than a high school education.
• Patients with a history of chronic pain were excluded from the sample.

• Single site
• Inpatient
• Taiwan

Randomized single-blind controlled trial

• Short-Form McGill Pain Questionnaire
• Visual analog scale (VAS), to assess pain
• Hospital Anxiety and Depression Scale (HADS)
• Measures of Demerol use per day

• There were no differences between groups regarding main effects on pain or anxiety. However, when time was added as a factor in statistical analysis, a significant difference between groups developed. Time-dependent changes showed that perceived pain decreased more in the intervention group (p < 0.0001) than in the control group. Pain scores on the VAS were lower in the intervention group over time (p < 0.0001).
• The pain score immediately after the intervention declined by a mean difference of 12.09 mm (p < 0.001).
• There were no main effects relating to anxiety; however, time-dependent changes in anxiety declined more in the intervention group than in the control group (p < 0.0001).
• Overall pain and anxiety declined in both groups over time. In the intervention group, the average daily dosage of Demerol was significantly lower (p = 0.015) than in the control group. Perceived pain was correlated with anxiety (r = 0.43, p = 0.001).

Foot reflexology as provided in this study may be helpful in reducing postoperative pain.

• The study had a small sample size, with fewer than 100 patients.
• The study had a risk of bias due to no appropriate attentional control group. Although the authors described this as a double-blind study, patients who received the intervention knew that they were receiving it and those who did not receive it knew that they did not. Additional attention from the intervention or patient expectations associated with the intervention may have affected findings. Without an attentional control, the existence and extent of these effects are unclear.
• The study was done in a single country. Responses may not apply to all cultural groups.

This type of intervention may be helpful in managing pain in postoperative patients. The relationship between anxiety and pain suggests that efforts to reduce anxiety may affect patients’ perceptions of pain.

Patients with colorectal cancer who experienced persistent diarrhea with fluorouracil (5-FU) and calcium folinate infusion despite dose reductions were treated with 800 mg/m², 500 mg/m², or 150 mg/m² amifostine. Amifostine works by selectively protecting normal but not tumor tissues from cytotoxic effects of radiation therapy and chemotherapy.

• The study reported on 52 consecutively recruited patients with colorectal cancer.
• To be eligible, patients must have
  • Had advanced metastatic or Dukes stage B2 or C colorectal cancer. 
  • Developed grade 3 and 4 or persistent grade 2 diarrhea (according to World Health Organization [WHO] classification) despite 10%–20% reduction in chemotherapy dose.
  • Been receiving adjuvant chemotherapy with 500 mg/m² 5-FU plus 50–100 mg/m² calcium folinate weekly. 
• With diarrhea recurrence, patients were assigned to one of three groups.
  • Group I (n = 18) received 800 mg/m² amifostine weekly.
  • Group II (n = 16) received a lowered dose of 500 mg/m² amifostine weekly.
  • Group III (n = 18) received a lowered dose of 150 mg/m² amifostine weekly.

• Continuous outcomes were compared using paired t-test (comparisons with baseline) or the independent sample t-test (between groups). Changes in heme parameters were analyzed using dichotomous (binary) variables of “decrease” or “increase.”
• Paired comparisons used the McNemar test; independent comparisons used Pearson’s chi-square.
• The primary endpoint was the proportion of 5-FU/calcium folinate doses associated with diarrhea or amifostine toxicity.
• Secondary endpoints were patient reports of chemotherapy-related adverse effects such as mucositis, anorexia, nausea and vomiting, and hematologic toxicity.

• The mean number of cycles of chemotherapy administered prior to amifostine was 6.55 (SD = 2.83). The median number of cycles was 9, and the range was 5–17.
• Incidence of diarrhea (using WHO classification) during baseline phase (n = 52) was as follows.
  • Degree 0: 9.9 %
  • Degree 1: 52%
  • Degree 2: 24.4 %
  • Degree 3: 9.9 %
  • Degree 4: 3.8 %
• All patients received diphenoxylate or loperamide to control diarrhea, 12 also were treated with octreotide until resolution of diarrhea, and seven were readmitted for dehydration.
• Compared with baseline, all doses of amifostine significantly reduced incidence of diarrhea (p < 0.0001 for each group). Amifostine was also found to be beneficial in decreasing mucositis (p < 0.04).
• No differences were found between groups regarding severity of diarrhea.
• A statistically significant difference (p < 0.04) was found in the mean number of administered doses of 5-FU between patients before and after treatment with amifostine. No significant difference was found between mean 5-FU doses during treatment with amifostine.
• A high incidence of adverse events was reported in group 1 (76.3%) despite complete resolution of grade 3–4 or persistent grade 1–2 5-FU-related diarrhea. The primary adverse effect was hypotension (0% at baseline in all groups), which was 76% in group 1, 54% in group 2, and 25% in group 3.

Although previous studies have found that doses of amifostine between 740–910 mg/m² are effective, this study suggested that lower doses may be effective and increase tolerability. The study suggested that 20% of the usual dose of amifostine is capable of offering adequate protection against diarrhea and mucositis associated with 5-FU. Although the 500 mg/m² and 800 mg/m² dose levels were equally effective in decreasing the risk of all grades of diarrhea, the lower dose was better tolerated. The 150 dose level was the best tolerated and was nearly as effective as higher doses in preventing severe and grade 1 diarrhea. Amifostine appears to offer protection against gastrointestinal adverse effects and permit higher doses of 5-FU.

• Amifostine side effects include hypotension, nausea, vomiting, chills, and dizziness.
• The study used WHO grading rather than the more common National Cancer Institute (NCI) Common Toxicity Criteria (CTC).
• The authors did not state the total dose of loperamide and other pharmacologic interventions used.
• No parallel nontreatment randomized control group was included, so the authors stated the results should not be “regarded as definitive.”

The study used the Usui method, which is the most common form of Reiki. Time varied but averaged about 45 minutes. The study used a randomized order:  Reiki for five consecutive sessions, a one-week washout, and two days of Reiki versus rest for five days with a one-week washout, and then one week of no treatment. The intervention was administered by a Reiki master.

• The study included 16 participants, including 13 women and 12 Caucasians, all with varying cancer types and times since chemotherapy.
• Median age was 59 years (range 33–84 years). 
• Patients were included if they had fatigue greater than 3 on 0-to-10 scale, understood English, and were living at home.
• Patients were undergoing long-term follow-up, but it was unclear how long it had been since chemotherapy was completed.

The study was conducted at an unspecified setting in Canada.

The study was a counterbalanced crossover, with eight participants randomized to each order.

• Functional Assessment of Cancer Therapy–Fatigue (FACT-F)
• FACT-General (FACT-G), before and after each period (Reiki or rest) 
• Edmonton Symptom Assessment Scale (ESAS), daily before and after treatment

About 88% of the participants completed all seven treatments. The effect was 0.56 (Reiki) versus 0.02 (rest) on the FACT-F and 0.27 (Reiki) versus 0.08 (rest) on the FACT-G. The paired t-test for the FACT-F was not significant (p = 0.24). Tiredness decreased daily over time.

• No analysis of order effect was conducted.
• The study had a small sample size.
• Multiple diagnoses, stages, and treatments were included.
• Analysis did not look at interaction effect.
• There was a problem with the inclusion criteria:  the range of time from diagnosis was 3 days to 3.79 years.

Interventions were of two conditions:

1. In the Reiki condition, participants received Reiki for five consecutive daily sessions, a one-week washout period of no treatments, then two additional Reiki sessions, and two weeks of no treatments.
2. In the rest condition, participants rested for one hour each day for five consecutive days, followed by a one-week washout period of no resting, and an additional week of no treatments.

Sixteen patients participated in the trial; eight were randomized to each order of condition (Reiki then rest; rest then Reiki). All sessions were administered from the same Reiki master.

• The study reported on a sample of 16 patients (13 women).
• Median patient age was 59 years.
• Patients had a variety of cancers, with the most common being colorectal (62.5%). Cancer stage ranged from I through IV.
• Patients were screened for fatigue (ESAS tiredness item); those scoring > 3 were eligible for the study.

The study was a counterbalanced crossover pilot trial of two conditions.

• Functional Assessment of Cancer Therapy: Fatigue (FACT-F): Questionnaire was completed prior to any intervention; higher scores indicate less fatigue.
• Edmonton Symptom Assessment Scale (ESAS): A patient-rated visual analog scale (VAS) is used to assess nine symptoms on severity.

There was a statistically significant change between the pre-first treatment and post-seventh treatment. Scores in the Reiki condition for anxiety were t(16) = 3.38, p < 0.005 (measured on the ESAS VAS for anxiety pre and post Reiki or rest). The Reiki condition demonstrated decrease in daily fatigue compared to rest alone.

The study is a well-designed crossover trial with randomization to groups.

The study had a very limited sample size.

To compare the treatment and retention effects between standard decongestive lymphatic therapy (DLT) combined with pneumatic compression and modified DLT in which the use of a short-stretch bandage is replaced with the use of Kinesio tape (K-tape) combined with penumatic compression

Patients were randomly grouped into the DLT group or the modified DLT group. During each treatment session, patients had skin care treatment, 30 minutes of manual lymphatic drainage, one hour of pneumatic compression therapy, application of a short-stretch bandage or K-tape, and 20 minutes of physical therapy. Evaluations were executed before and after the control period, after the intervention period, and after the three-month follow-up. A well-trained physical therapist who was blind to the groupings evaluated all patients.

• The study sample (N = 41) was comprised of two groups, a DLT group (n = 21) and a modified DLT group (n =20), of female patients with breast cancer.
• Mean age of patients was 54.6 years with a range of 36–75 years.
• Patients were included in the study if they had unilateral breast cancer-related lymphedema for more than three months that was moderate to severe (circumference of affected limb greater than that of the unaffected limb by more than 2 cm at one or more sites.

The study took place in Taiwan.

The study used a randomized, single-blinded, controlled design.

• Upper-extremity circumference and water displacement volume were measured.
• Water composition of the upper extremity: An eight-polar tactile-electrode impedance meter was used in the water composition analysis of the upper extremity.
• Lymphedema-related symptoms were assessed by a visual analog scale from 0–10 (0 = none, 10 = worst possible).
• Quality of life was assessed using The Taiwan Chinese Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 and QLQ-BR23)
• Subjects’ response to bandage or K-tape was noted.

There was no significant difference between groups in all outcome variables (p > 0.05). Excess limb size (circumference and water displacement) and excess water composition were reduced significantly in the bandage group. Excess circumference and excess water composition were reduced significantly in the tape group. The acceptance of K-tape was better than the bandage and benefits included longer wearing time, less difficulty in usage, and increased comfort and convenience (p < 0.05). However, there were more wounds that occurred for those in the K-tape group (p < 0.05).

The study results suggest that K-tape could be an alternative choice for patients with breast cancer-related lymphedema with poor short-stretch bandage compliance after one month of intervention.

• The study sample was small with less than 100 patients.
• There were more wounds caused by the use of K-tape than bandages.
• The exact reasons why there were a greater number of wounds in the K-tape group needs to be further explored.

The safety of application of K-tape (i.e., wound) needs to be closely monitored. Patients need to be educated regarding how to use K-tape.

STUDY PURPOSE: To evaluate the effects of music on symptoms in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: Ovid, PsycARTICLES, and PsycINFO (2002–2012)

KEYWORDS: neoplasms, cancer, and music or melody

INCLUSION CRITERIA: Used a music intervention in patients with cancer; quantitative methods; quasi-experimental or experimental design; reported statistical information to describe results; evaluated effects on anxiety, depression, pain, or fatigue

EXCLUSION CRITERIA: Qualitative design, case studies, or single-group studies

TOTAL REFERENCES RETRIEVED = 367

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Quality assessment with adapted Cochrane guidelines; the k value between reviewers was 0.9.

• FINAL NUMBER STUDIES INCLUDED =  21–17 for anxiety, 8 for depression, 6 for pain, and 5 for fatigue
• SAMPLE RANGE ACROSS STUDIES = 32–126

APPLICATIONS: Pediatrics, palliative care

For anxiety, music therapy had a moderate and significant effect with an effect size of -0.553 (Hedges; g) (95% CI -0.716, -0.398). There was significant heterogeneity in the sample. For depression, music therapy moderately and significantly reduced depression with an effect size for each study ranging from -0.151 to -0.787. Results were homogenous. Five of eight studies showed significant effects. For pain, music had an overall effect size of -0.656 (Hedges' g) (95% CI -1.016 to about -0.295), showing moderate-level effects on pain. There was significant heterogeneity among studies. For fatigue, music therapy had a small effect size of -0.422 (Hedges' g) (95% CI -0.669, -0.175). Results were homogenous. Studies were seen to be of good quality. Results of subgroup analysis suggest that music therapy is more effective in adults than children and more beneficial when the music is selected by the patient rather than the therapist.

This analysis shows that music interventions can reduce anxiety, depression, pain, and fatigue in patients with cancer with small-to-moderate effect sizes.

In several areas, there was high heterogeneity. Sample sizes, timing, and types of music interventions varied substantially, and, in most, the impact was evaluated immediately after the music intervention. Whether music has ongoing effectiveness with continued use or any lasting effect on the symptoms assessed is unclear.

Music interventions can be a good adjunctive and non-medication therapy that is of benefit in reducing anxiety, depression, pain, and fatigue in patients with cancer. The most beneficial ways and times to use music therapy are unclear. Nurses can suggest that patients use listening to music as part of self-care and can advocate for use of music as a low-risk intervention to ameliorate acute anxiety and pain symptoms.

Assess the effect of palmitoylethanolamide (PEA) on pain and nerve function in patients with chemotherapy-induced painful neuropathy receiving bortezomib and thalidomide for multiple myeloma.

Patients with a score of at least 4 on a Douleur Neuropathique 4 (DN4) screening tool for neuropathic pain were given 600 mg daily for two months during treatment with bortezomib and thalidomide. Study measurements were done before and after the administration of palmitoylethanolamide (PEA).

• N = 20   
• AGE = Not stated
• MALES and FEMALES (%) = Not stated
• KEY DISEASE CHARACTERISTICS: All patients had multiple myeloma.
• OTHER KEY SAMPLE CHARACTERISTICS: All patients had touch/vibration hypoesthesia, seven had hyoalfesia, and five had abnormal thermal sensation. All had ongoing pain. None had paroxysmal pain or allodynia.

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

PHASE OF CARE: Active antitumor treatment

Prospective trial
 

• Nerve assessment for touch, vibration, and pinprick sensation
• Warmth sensation threshold assessed with yttrium aluminum perovskite (YAP) laser
• Motor and sensory nerve conduction studies

In four patients, the chemotherapy dose was reduced due to non-neuropathic problems. After two months of treatment with PEA, pain scores were significantly reduced (p < .002). Warmth threshold was not significantly changed. Ulnar, sural, and peroneal amplitudes were significantly increased (p < .03).

PEA may be of benefit in reducing pain and improving myelinated fibre function in patients who have chemotherapy-induced neuropathic symptoms.

• Small sample of < 30
• Risk of bias (no control group) 
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods were not well described.
• Method of pain measurement was not described.
• Patient demographic characteristics were not described.

PEA may be a therapeutic tool for patients with painful chemotherapy-induced peripheral neuropathy; however, significant limitations as seen in this study contribute to a lack of evidence strength in this area. Further research of this intervention is warranted, as there are few known effective interventions for this problem.

Iseganan HCL oral solution for reduction of severity of oral mucositis in patients receiving radiotherapy for head and neck malignancy.

9 mg doses of iseganan plus institute-specific standard of care (SOC) management of oral hygiene, or placebo plus SOC, or SOC alone (n = 81) in a 3;2;1 distribution. Drug administered within three days before and not more than two days after start RT and continued daily until last day of RT.

The study was comprised of 505 patients, ≥18 years old, with a median range of 56–58 years.

9 mg doses of iseganan plus institute-specific standard of care (SOC) management of oral hygiene (n = 253). 

Placebo plus SOC (n = 171)

SOC alone (n = 81)

Head and neck cancer, scheduled to receive minimum of 60 Gy to no less than three protocol specified anatomic sites each a min of 2 cm² area of mucosa.
 

Multi-site: 53 institutions US, Canada, France, Germany, UK

July 2000 – Dec 2001

RCT

Double blind if study drug or placebo

NCI-CTC radiation mucositis scale, pain, and difficulty swallowing (0 – 10)
Saliva samples for quantitative and qualitative microbiologic assessments
Assessments performed twice weekly during RT and four and eight weeks after completion.
 

No difference between iseganan and placebo groups for any study endpoint.

Iseganan group – fewer developed ulcerative OM and experienced less severe OM than SOC alone, also smaller proportion of placebo group developed ulcerative OM than SOC alone.

Emphasis on oral rinsing or the vehicle solution used may significantly reduce the incidence and severity of RT-induced ulcerative OM and associated clinical outcomes.

 

No positive effect

Study concludes with statement that “iseganan oral solution is safe and well tolerated in patients with compromised oral mucosa while receiving RT for head and neck cancer. Investigations with iseganan in clinical settings where infection is a known and significant factor should continue.” However, the treatment effect was not significant.

Sponsored by IntraBiotics Pharmaceuticals – R. Redman and H. Fuchs are employees of IntraBiotics; some authors were paid consultants.

No positive effect

Contributes to mixed findings regarding antimicrobial agents and mucositis

The purpose of this article was to determine the clinical response identified as quality of life, including fatigue and neutropenia, in patients receiving CAF for breast cancer with additional treatment with mistletoe extract compared to chemotherapy alone.

Ninety-five patients were randomized into three groups. All patients received chemotherapy with six cycles of chemotherapy with cyclophosphamide, adriamycin, and 5-flourouracil (CAF). Two groups also received Iscador administered by subcutaneous injection, containing 1 ml of varying amounts of fermented extract of fresh mistletoe herb or a different mistletoe preparation. IMS was incrementally increased from 0.01–5 mg of the herb in isotonic saline. The control group (n = 31) was compared to group who received IMS (n = 30). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QOQ-C30) was used to assess quality of life, including fatigue. An absolute neutrophil count of less than 1,000 mcl defined neutropenia and was assessed at baseline and one day prior to each cycle of CAF chemotherapy.

• The total sample size was 60 with all participants aged 18 or older.
• All participants were female
• All had early-stage breast cancer (stages T_1-3N_0-2M₀)
• Participants had to be female, 18 years or older, have a Karnofsky-Index of 60 or greater, leucocytes of 3,000/mm³ or higher, thrombocytes of 100,000/mm³ or higher, serum creatinine of 2 mg or less, serum glutamic oxaloacetic transaminase (SGOT), and serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 times the upper institutional limits
• Women were excluded if they were pregnant or lactating, had metastatic disease, planned to receive hormone or radiation therapy during six cycles of CAF, used immunostimulant or immunosuppressive agents (e.g., corticosteroids) except for nausea and vomiting, were currently taking other investigational agents, had clinically relevant physical or mental illness including serious infections, hepatic, renal or other organ dysfunction, had major depression, suffered from alcohol abuse or alcoholism, suffered from drug abuse either oral or parental, and were in methadone treatment.
   

A single-site oncology and radiology institute in Belgrade, Serbia

• The phase of care was during active treatment with chemotherapy
• Application was for  prevention of infection; quality of life with neutropenia
   

Prospective, randomized, open-label pilot

• EORTC-QLQ-C30
• Neutropenia assessment was reported by measuring the number of patients with less than 1,000 mcl neutrophils throughout the study.    
   

Quality of life decreased from baseline in all scores of control group participants and in six scores in the IMS group. The most significant decreases in scores were seen for nausea/emesis (17.2 score points) and fatigue (8.2 score points) following the second cycle of CAF chemotherapy. Decreases in insomnia (13.1 score points) and diarrhea (11.9 score points) were reported after the third cycle of CAF chemotherapy.

An adjusted analyses that compared mean differences from baseline of the control and IMS groups revealed that all 15 comparisons favored the IMS group, 12 comparisons showed significant differences (p = 0.017–0.001). The IMS group were favored over the control group, with a clinically relevant differences of 5 points or more for nine of the EORTC-QLQ-C30 scores. Statistically significant improvement in symptoms with IMS compared to controls were found for physical functioning, role functioning, emotional functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties

Neutropenia was identified three times in three different patients within the IMS group and nine times in eight different patients of the control group. Odds ratio for the proportion of patients with neutropenia in IMS group versus control group was 0.32 (95% CI [0.08, 1.35]).  

Localized skin reactions to IMS occurred in six patients. No other adverse events were reported, and findings with use of the other mistletoe preparation are not reported.
 

For patients receiving CAF chemotherapy for early stage-breast cancer, adding mistletoe therapy improved quality of life and demonstrated a trend toward reduction of neutropenia.

• Sample size was small
• Trial was not blinded or placebo controlled.  It is not clear if there was an effect simply because patients were receiving an injection. 
• No information on the other mistletoe preparation is provided. 
• Effects on neutropenia cannot be really evaluated due to limited information reported. 
• There was only a 120 day follow-up period.
   

Findings suggest that mistletoe might have some applicability in managing symptoms for patients with cancer, and may have an effect on neutropenia. Findings of this study are severely effected by limitations in study design and the small sample size that makes meaningful analysis of some outcomes of interest difficult. As a result, this study does not provide strong support for efficacy of mistletoe use.