RESOURCE TYPE: Consensus-based guideline  

PROCESS OF DEVELOPMENT: Review of selected literature and retrospective review of 63 patients hospitalized for CID

PHASE OF CARE: Active antitumor treatment

No specific broad search and literature review were used. A few study findings are cited. No information was provided regarding the strength of evidence cited.

• Recommends CID severity grading using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
• Notes the lack of and need for information identifying risk factors and development of a predictive model for CID severity
• Outlines methods for patient evaluation of possible causes of diarrhea and workup to include complete and differential blood count, blood chemistry, and stool analysis
• Recommends dietary management eliminating caffeine, alcohol, lactose, and high-fat foods
• Identifies loperamide or high-dose loperamide as first-line treatment, octreotide for intractable grade 1 or 2 diarrhea, and fluid/electrolyte replacement for grade 3 or 4 diarrhea
• Recommends consideration of long-acting octreotide for patients who had grade 3 or 4 diarrhea in a previous chemotherapy cycle as prophylaxis

• Mainly consensus-based guideline

Algorithm and consensus recommendations are provided for management of CID. Although these guidelines are aimed specifically at colorectal cancer cases, principles are likely to apply to other tumor types. Whether the mechanisms of diarrhea, and, therefore, effective treatments, are the same with various chemotherapy agents is unclear, and research is limited in this area. Prophylactic use of octreotide is suggested for patients who had diarrhea in a previous cycle of treatment in order to attempt to avoid the need for dose reductions or treatment delays.

To evaluate the efficacy of supersaturated calcium phosphate rinse (SCPR) with customary care (topical mouth solutions) on measures of severity and consequent interventions and complications  

In the treatment group, patients rinsed their mouths four times daily with the SCPR. In the control group, patients received customary topical mouth care with the extract of salvia leaves (twice daily), providone-iodine mouth solution (1% water solution of iodide with polyvinylpyrrolidone) once daily, and fluconazole mouth solution (50 mg fluconazole, 50 mg glycerine, 10 g vitamin A, and 10 g vitamin E with or without 2.5 g benzociaine) twice daily.

The SCPR treatment was administered from the first day of conditioning until patients reached the absolute neutrophil count of greater or equal to 0.2 g/l (a value that was considered an indication of the beginning of neutrophil recovery). Patients self-assessed the level of pain in the mouth and pharynx using a 0–10 visual analog scale (VAS) and measured swallowing problems using a 0–5 VAS.

The same experienced hematologist performed a physical examination of the oral cavity each day throughout the study, ranking cases according to the World Health Organization (WHO) scale for grading oral toxic effects of cancer treatment.

• The study reported on a sample of 40 patients. The SCPR group mean age was 38, with a range of 19–57 years. The control group mean age was 26, with a range of 20–57 years.
• The SCPR group had 13 males and 7 females, and the control group had 11 males and 9 females.
• The SCPR group had 8 patients with acute myelogenous leukemia (AML), 5 with acute lymphocytic leukemia (ALL), 2 with chronic myelogenous leukemia (CML), 3 with paroxysmal nocturnal hemoglobinuria (PNH), and 2 with other cancers (osteomyelfibrosis, myelodysplastic syndrome, severe aplastic anemia).
• The control group consisted of 12 patients with AML, 5 patients with ALL, 1 patient with PNH, and 2 patients with other (see above).
• In the SCPR group, 9 patients were receiving busulfan (16 mg/kg) and cyclophosphamide (120 mg/kg), 5 patients were receiving total body irradiation (TBI) of 12 Gy and 120 mg/kg cyclophosphamide, and 6 were receiving treosulfan (42 g/m²) and fludarabine (150 mg/m²).
• In the control group, 9 patients were receiving busulfan (16 mg/kg) and cyclophosphamide (120 mg/kg), 5 were receiving TBI (12 Gy) and 120 mg/kg cyclophosphamide, 4 were receiving treosulfan (42 g/m²) and fludarabine (150 mg/m²), 1 was receiving treosulfan (20 g/m²) and cyclophosphamide (160 mg/kg) and 1 was receiving cyclophosphamide (200 mg/kg). 
• In the SCPR group, 5 patients were receiving transplants from sibling donors and 15 from unrelated donors. In the control group, 4 were receiving transplants from sibling donors and 16 from unrelated donors.

This was a single-site study conducted in an inpatient setting. The study was conducted at the Department of Hematology and Bone Marrow Transplantation at the Medical University of Silesia in Katowice, Poland, in 2009.

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

This was a prospective randomized, non-blinded, controlled trial with 40 consecutive patients undergoing allogeneic hematopoietic stem cell transplant (HSCT). Half of the patients received treatment with the supersaturated rinse, and the remaining half received customary care with topical mouth solutions. Patients enrolled in this study underwent transplantation in the Medical University of Silesia in Katowice, Poland, in 2009.

The World Health Organization scale (WHO) was used to measure severity of mucositis. Duration was recorded in days. Peak mean pain in mouth was recorded using a 0–10 visual analog scale (VAS). Peak mean swallowing problems were recorded using a 0–5 VAS. Days to absolute neutrophil count of more than 0.5 g/L and days to platelets of more than 20 g/L were recorded.  

Interventions and complications were measured in terms of duration of analgesics used (days), duration of total parenteral nutrition (TPN) (days), use of granulocyte colony-stimulating factor (G-CSF), incidence of acute graft-versus-host disease (aGVHD), degree of aGVHD, and incidence of infectious complications.

• Compared with the control group, the SCPR mouth rinse group demonstrated significantly lower means measures of oral toxicity, peak mouth pain, and disease course duration.
• WHO oral toxicity scores were statistically lower in the SCPR group (p = 0.02) compared to the control group.
• Disease course for the SCPR group was statistically shorter (p = 0.02) and peak mouth pain was statistically lower in the SCPR group (p = 0.005).
• Days of analgesic needs were shorter for the SCPR group (p = 0.047).
• The need for patients needing TPN in the SCPR group was lower (p = 0.02), and the mean days of TPN was lower in the SCPR group (p = 0.009).

The findings in this prospective randomized, controlled study confirm findings in a 1992 report of a double-blind, prospective, randomized, controlled trial of 95 patients undergoing HSCT. In that trial, SCPR produced statistically significantly lower measures of pain duration, disease course duration, use of analgesics (morphine), and duration of time to absolute neutrophil recovery than did a fluoride rinse, demonstrating the SCPR regimen has a significant positive effect on oral mucositis associated with chemotherapy and radiotherapy.

• The sample size was small with fewer than 100 patients.
• The iodine solution (red) contrasted dramatically in color with the SCPR solution (colorless), thus making it difficult to disguise the difference and, therefore, making the study unblinded.
• The red color of the iodine solution may have obscured assessment of the oral cavity.
• It may be able to generalize these results to other settings because the control group treatment is not necessarily widely accepted as the standard of care for the prevention and treatment of mucositis. 

These results warrant confirmation in controlled, multicenter, randomized trials. The use of a supersaturated calcium phosphate rinse holds promise for the prevention and early resolution of oral mucositis and appears to have no significant side effects when used four times daily in patients receiving stem cell transplant.

Databases searched were Cochrane Breast Cancer Specialised Register, MEDLINE, EMBASE, CINAHL, SPORTDiscus, PsycINFO, SIGLE, ProQuest Digital Dissertations, and Conference Papers Index through July 2004.

Treatment evaluated aerobic (walking or cycle ergometer interval training) or resistance exercise, or a combination of both. Exercise programs were of moderate or low intensity, and the interventions included a mixture of supervised and self-directed programs, delivered individually, or in groups.

To be included in this meta-analysis, the exercise intervention had to be of at least six weeks' duration and had to coincide with the adjuvant treatment regimen rather than follow it. Trials in which the exercise intervention was part of a complex intervention (e.g., complete decongestive lymphatic therapy) and trials restricted to local muscular endurance (e.g., training of shoulders, back, or legs only) instead of including all major muscle groups or restricted to stretching exercises were also excluded.

Seven randomized trials and two nonrandomized, controlled trials involving 452 participants met the inclusion criteria. Five trials, involving 317 participants, were used in the meta-analysis specifically for the outcome of fatigue.

• Sample size was common among included trials, with only two trials having more than 30 participants.  Median sample size was 42 patients.
• Women were undergoing adjuvant (including neoadjuvant) treatment (including chemotherapy, hormonal therapy, or radiotherapy, sequentially or concurrently) for stage I, II, and III breast cancer.

Outcomes were physical fitness, psychological distress, symptoms (pain and fatigue), quality of life, body weight or lean body mass, and immune function. Fatigue was evaluated predominantly using the Piper Fatigue Scale. Meta-analysis of the trials in which fatigue was included as an outcome did not identify a statistically significant improvement in fatigue for participants in the exercise intervention groups compared to the control (nonexercising) groups. Statistically significant improvements for cardiorespiratory fitness, anxiety, sleep disturbance, and nausea relief were found.

The methodologic quality of the studies was overall moderate.

• The absence of blinding of the outcome assessor was the most prominent methodologic flaw.
• The conclusions that can be drawn from this review are limited based on the inclusion of only a small number of trials, together with a considerable degree of clinical heterogeneity regarding adjuvant cancer treatments and exercise interventions.

To facilitate dose escalation of strong opioids by using an opioid-tramadol combination

Of 70 patients, 35 were treated conventionally, with increasing transdermal fentanyl (group F). The other 35 patients received oral tramadol added to their fentanyl before each increment of their transdermal opioid (group T). Patients started fentanyl therapy by taking 25, 50, 75, or 100 mcg/hour, the amount based on equianalgesic dosing. Maximum tramadol dose was 400 mg/day. Rectal tramadol was not used.

• The sample was composed of 70 patients with intractable cancer pain whose visual analog pain score was greater than 3.
• All patients were receiving palliative care and not in the active treatment phase of disease.

The study was conducted in Italy.

Randomized open-label, prospectively evaluated study

Authors used a visual analog scale (VAS) to measure pain.

• In group F, 33 patients completed the study; in group T, 34 patients completed the study.
• Pain was equal in both groups; VAS scores did not differ. However, pain control in the tramadol group was achieved at slower escalation of fentanyl dose. The combination of a strong opioid with a weak opioid, to treat severe cancer pain, allowed a more gradual increase of analgesic delivery. Therefore, the combination minimized periods of overdosing and underdosing.
• Application time for patches was significantly higher in group T. In group T, no patient's fentanyl patch dose changed before the patient reached the maximum tramadol dose of 400 mg per day.
• Regarding adequacy of treatment, patients’, relatives’, and physicians’ judgments did not differ.

The combination of a strong opioid and a weak opioid, to treat severe cancer pain, allowed a more gradual increase of analgesic delivery. Therefore, the combination treatment minimized periods of overdosing and underdosing. Combination treatment as specified is a useful alternative, especially when disease and pain progress quickly.

Severe nausea and vomiting occurred in six patients in group T and three in group F, possibly due to a synergistic effect between fentanyl and tramadol. This study was insufficiently powered to show statistically significant differences relating to uncommon or serious side effects.

The greater number of fentanyl dose changes associated with higher fentanyl consumption in group F may support the hypothesis that tolerance is a pharmacologic effect, rather than a result of the rapid progression of disease. Additional study of the synergistic effect of tramadol and fentanyl, with respect to severe nausea and vomiting, is needed.

To evaluate the use of hypnosis in the management of anticipatory nausea and vomiting

Patients received two hours of training in progressive relaxation, followed by a one-hour hypnosis program. No drugs were given in association with the hypnotherapy. After the intervention, patients immediately went to their scheduled chemotherapy.

• The study consisted of 16 adults with anticipatory nausea and vomiting from at least four previous courses of chemotherapy.
• The majority of the sample was female (n = 14).
• Median age was 44 years.
• Patients did not have metastatic disease to the brain or gastrointestinal (GI) tract.
• Cancer types included were ovarian, Hodgkin, testicular, lung, and breast.
• Chemotherapy received included cisplatin, carboplatin, cyclophosphamide, dacarbazine, doxorubicin, and epirubicin.
• All patients had to have previously undergone four cycles of 5-HT₃ and developed nausea and vomiting.
• The sample was a convenience sample.

All patients were from an outpatient setting.

A Visual Analog Scale (VAS) was used to measure complete response (CR) (mild nausea with no vomiting), major response (moderate to severe nausea and one vomiting episode), or no response (none of the above).

In all of the 16 patients in the study, anticipatory nausea and vomiting disappeared. Major responses (moderate to severe nausea, with one vomiting episode) to chemotherapy-induced emesis control occurred in 14 of the 16 patients.

• The study included a very small population.
• No interrater reliability was reported.
• No control group was used.
• Patients with brain metastasis or cognitive disabilities were excluded.

Caution should be used regarding patient selection; some patients should not be hypnotized.

To investigate the effects of dexmethylphenidate (d-MPH) on fatigue and cognitive function in women undergoing adjuvant chemotherapy for early breast cancer

Participants were randomized to a placebo group or a treatment group receiving d-MPH. The treatment group was started on 5 mg twice a day of d-MPH. If this was well-tolerated, the dose was increased one week later to 10 mg twice a day. The treatment group then continued taking d-MPH at a maximum of 10 mg twice a day until the end of the final cycle of chemotherapy. If participants did not tolerate 10 mg twice a day, the dose was reduced to 5 mg twice a day for the remainder of their treatment.

• The total number of participants was 57.
• The treatment group had 29 participants, and the placebo group had 28 participants.
• The median age of the treatment group was 50, with a range of 36–72.
• The median age of the placebo group was 51, with a range of 37–74.
• All participants were female.
• All participants had breast cancer.
• All participants were scheduled to receive four or more cycles of adjuvant chemotherapy and were enrolled after at least one cycle of chemotherapy.

Three hospital-based outpatient clinics in Toronto, Canada

Prospective, randomized, double-blind, placebo-controlled trial

• Mini-Mental State Examination ((MMSE) for global cognitive functioning
• High Sensitivity Cognitive Screen (HSCS) for memory, language, attention, concentration, visual-motor, spatial, and self-regulation
• Hopkins Verbal Learning Test-Revised (HVLT-R) for immediate and delayed recall (alternate forms used)
• Functional Assessment of Cancer Therapy-General (FACT-G) for cancer-related quality of life
• Functional Assessment of Cancer Therapy (FACT-F) for cancer-related quality of life pertaining to fatigue symptoms
• Hospital Anxiety and Depression Scale (HADS)

No difference was seen between groups on any of the cognitive assessments completed at baseline, end of chemotherapy, and at six-month follow-up.

The study failed to demonstrate a beneficial effect of d-MPH on either fatigue or cognitive dysfunction during adjuvant chemotherapy for breast cancer.

• No baseline assessment of cognitive function was conducted prior to chemotherapy treatment; the baseline assessment was completed after the participant already had received at least one cycle of chemotherapy. 
• No descriptive information was provided regarding the sample (e.g., educational level, disease stage).
• The study was closed early because of failure to achieve the accrual goal. This primarily was due to patient reluctance to take additional medication in general and d-MPH in particular. 
• HSCS is subject to substantial practice effect and is not recommended for serial measures.
• The sample size was insufficient to achieve the necessary statistical power.

The study was conducted to investigate post-hoc the potential impact of erythropoietin on cognitive function following chemotherapy for breast cancer.

Patients were randomized when their hemoglobin (Hgb) level decreased to ≤ 12 g/dL. Depending on the remaining duration of chemotherapy, erythropoietin was administered for a period of time between 16 or 28 weeks. Patients were randomized to receive either 40,000 units of erythropoietin weekly or the standard of care.

• All participants were female and had breast cancer.
• Participants were selected from a primary study group receiving adjuvant chemotherapy.
• The number of participants was 87.
• The number of participants in the treatment group (erythropoietin arm) was 45.
• The number of participants in the control group (standard care) was 42.
• Participants spent an average of 23 months in the intervention group and 24 months in the standard-of-care group. 

This multi-site study took place in Canada.

The study was a randomized, controlled trial.

• Primary Cognitive Endpoint: Proportion with moderate-severe cognitive impairment at 12–30 months following completion of chemotherapy as measured by High Sensitivity Cognitive Screen (HSCS) for memory, language, attention, concentration, visual motor, spatial, and self-regulation
• Secondary Cognitive Endpoint: Proportion that scored in lowest quartile of any of four variables in the Hopkins Verbal Learning test–Revised (HVLT-R) for total recall, delayed recall percent retained, and discrimination index
• Functional Assessment of Cancer Therapy (FACT)-F for cancer-related quality of life specific to symptoms of fatigue
• Hospital Anxiety and Depression Scale (HADS) for anxiety and depression.

Participants showed no improvement in cognitive function or fatigue, as measured by the HSCS or HVLT-R. There was reported improvement in quality of life.

The study failed to demonstrate a protective effect of erythropoietin on cognitive dysfunction after chemotherapy in survivors of breast cancer.

• The study had a small sample size, given the variability in chemotherapy regimens and use of hormonal therapy.
• No baseline testing of cognitive function was conducted.
• The study lacked a control group.
• There were significant differences between groups in overall quality-of-life, anxiety, and depression scores.
• The selection of the delayed 12–30 month time frame may not have been the ideal time for assessment of the impact of erythropoietin on cognitive function.
• HSCS has not been shown to be a very sensitive test for detecting subtle cognitive impairments in the sample population. 

To evaluate the effects of electroacupuncture (EA) versus gabapentin (GP) for hot flashes among survivors of breast cancer, with a specific focus on the placebo, using sham acupuncture (SA) and placebo pills (PP), and monitoring nocebo effects.

• N = 120  
• AGE RANGE: 31–79 years
• MEAN AGE = 52.3 years (SD = 8.5 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: The study included women with breast cancer (stages I–III) who were free of disease and who have at least two hot flashes each day. Women could not be receiving active chemotherapy/radiation therapy and could be on hormonal therapy; however, the hormonal therapy could not have been initiated or changed within four weeks of starting the study.
• OTHER KEY SAMPLE CHARACTERISTICS: Women who were pregnant, breastfeeding, or anticipated a change in hormonal therapy were not included, neither were women receiving coumadin, women who had a bleeding disorder, women who were receiving an anticonvulsant, women who had taken gabapentin in the past for hot flashes, or women who had renal failure in the prior 12 months. 74.2% of women were Caucasian; 22.5% were African American; 87.5% were postmenopausal; 25% had surgically induced menopause; 39.2% had chemotherapy-induced menopause; 67.5% were receiving hormonal therapy; and 25% were receiving an antidepressant.

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Abramson Cancer Center of the University of Pennsylvania in Philadelphia

• PHASE OF CARE: Transition phase after active treatment

• Randomized, placebo, controlled trial

• Daily hot flash diary

By week eight, SA produced significantly greater reduction in HFCS than did PP (-2.39; 95% CI [-4.6, -0.17]). Among all treatment groups, the mean reduction of HFCS was greater in the EA group, followed by SA, GP, and PP (-7.4 vs -5.9 vs -5.2 vs -3.4; p = < 0.001). The pill groups had more treatment-related adverse effects than did the acupuncture groups; GP (39.3%), PP (20%), EA (16.7%), and SA (3.1 %), with p = 0.005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (-8.5 vs -6 vs -4.6 vs -2.8; p = 0.002).

EA resulted in the greatest reduction in hot flashes both at the end of the treatment and four months after the treatment. GP had similar effects while women received treatment, but not off treatment. Acupuncture (both SA and EA) elicited greater placebo and smaller nocebo effects than did GP or PPs for the management of hot flashes.

• Intervention expensive, impractical, or training needs
• The training required to accurately administer EA is of concern and was not thoroughly addressed.
• The sample size was small for a four-group study.

The EA group was found to have enhanced effects of reducing hot flashes in breast cancer survivors; however, SA also had better effects in reducing hot flashes than either GP or PPs. GP was associated with the most adverse effects, and the PP group reported more nocebo effects than did SA. This might be important information for nurses to be aware of as they provide education to patients.

To examine electroacupuncture (EA) compared to sham acupuncture (SA) and a waitlist control (WLC) group to determine effectiveness on fatigue, sleep disturbance, depression, and anxiety in postmenopausal breast cancer survivors who reported joint pain, or arthralgia, related to aromatase inhibitors (anastrazole, letrozole, exemestane)

Acupuncture interventions were administered by two licensed acupuncturists (not physicians). Ten treatments were administered over eight weeks with two treatments during each of the first two weeks followed by one treatment per week for the following six weeks. The EA and SA treatments were administered by the same two acupuncturists. Procedures for the two groups differed in the placement of the acupuncture needles and actual versus sham electrical stimulation using a transcutaneous electrical nerve stimulation (TENS) unit. The same timing and duration of treatments was used for each group.

• N = 67 (159 were screened; 76 were enrolled; 9 were excluded during the next round of evaluations; 4 were lost to follow-up by time 2 [4 weeks] and 4 more were lost to follow-up by time 3 [12 weeks])  
• MEAN AGE: 59.7 years (range = 41–76 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors being treated with aromatase inhibitors (AIs) for 3–56 months. 66% of participants were being treated with an AI at the time of the study. At baseline, there were significant correlations between baseline pain (as measured by the Brief Pain Inventory) and fatigue, sleep, and depression, but there was no correlation with anxiety. Most participants (71.6%) were white and 23.9% were black; greater than 75% reported college education. Disease: 48%–50% were at disease stage I, 30–36 % were at disease stage II, and 14%–22 % were at disease stage III.  
• OTHER KEY SAMPLE CHARACTERISTICS: Most participants (71.6%) were white and 23.9% were black; greater than 75% held some college education. Inclusion criteria: Women with histories of stages I–III breast cancer currently taking an AI, current complaints of joint pain times three months, attributes pain to AI, current-week pain rating of 4 or greater on an 11-point rating (0–10), complaints of pain at least 15 days within the last 30 days. 

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: The Abramson Cancer Center of the Hospital of the University of Pennsylvania

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

Three-group randomized controlled trial comparing EA, SA, and WLC.

Four measurement tools were used: the Brief Pain Inventory (BPI); the Brief Fatigue Inventory (BFI); the Pittsburgh Sleep Quality Index (PSQI); and the Hospital Anxiety and Depression Scale (HADS). A priori primary outcome reported pain intensity and interference. A priori secondary outcome reported fatigue, sleep, and psychological distress (anxiety, depression).

Measurements were repeated at weeks 4, 8, and 12. There was significant (p = 0.0095) improvement in the fatigue score after EA, no improvement with SA, and greater reduction in fatigue than the WLC group. There were nonsignificant improvements in sleep in the EA and SA groups compared to the WLC group. There was significant (p = 0.04) improvement in the EA group but the SA group on the HADS anxiety score compared to the WLC group; a nonsignificant improvement continued in the EA group at week 8, whereas week 12 showed a significant (p = 0.006) improvement in the EA and WLC groups. EA and SA group improvements in depression scores were significant (p = 0.015 and p = 0.0088, respectively) compared with the WLC group; EA and SA significantly (p = 0.0031m and p = 0.0056, respectively) improved scores at week 8, and scores did not change at week 12.

EA produced improvements by reducing fatigue, anxiety, and depression scores. SA produced improvements in depression scores only. Acupuncture with electronic stimulation may be an effective treatment for pain and the nonpain symptoms of fatigue, sleep disturbance, and depression associated with AIs. Additional research is encouraged.

• Small sample (< 100)
• Risk of bias (no blinding). There was no blinding but the risk of bias is low because each arm of the study required specific treatment limited to administration by just two acupuncturists.

Acupuncture with electrical stimulation should be considered a viable treatment option for patients with breast cancer taking AIs who complain of joint pain. Large, randomized, controlled research studies are needed to develop evidence for the efficacy of EA in breast and other cancers. Drug and symptom cluster correlations must be deconstructed.

To test the hypothesis that electroacupuncture (EA) would improve function and reduce arthralgia compared to usual care

Patients were randomized to wait-list control, EA, or sham acupuncture (SA) groups. Acupuncture was given twice a week for two weeks, then weekly, for a total of 10 treatments over eight weeks. SA treatment frequency and duration were the same as for EA. Study assessments were done at baseline, after eight weeks, and at week 12.

• N = 36
• MEAN AGE = 59.67 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All received aromatase inhibitors ranging from 19.5–31.1 months across groups. Duration of joint pain ranged from 43.4–62.9 on average. Duration was highly variable across groups.

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

• PHASE OF CARE: Active antitumor treatment

• Double-blind, placebo-controlled RCT

• Brief Pain Inventory (BPI)
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
• Quick Disability of Arm Shoulder Hand (DASH)
• Physical Performance Test (PPT)

At week 8  and week 12, the EA group had a greater reduction in pain severity and pain interference compared to the wait-list control group (p < .001). The EA group also had greater improvement in DASH scores and outcomes, as measured by the WOMAC index compared to controls. The SA group also had a significantly greater reduction in pain severity and interference compared to controls at week 8 and week 12 (p < .005). No significant differences were seen between the SA and EA groups.

EA and SA were associated with reduction in arthralgia pain severity and interference and improvement in joint disability measures.

• Small sample (less than 100)
• Subject withdrawals 10% ore more
• No information is provided regarding pain medication use.
• Withdrawals were high, suggesting that the intervention may not be acceptable or practical for many patients.

Findings suggest that EA and placebo acupuncture resulted in reduced pain from arthralgia in patients receiving aromatase inhibitors. Although this study was well designed, the sample size was small, and a substantial number of participants dropped out. Placebo effects of acupuncture or SA may help to alleviate arthralgia pain in these patients, and this approach may be acceptable or preferred by some patients.