Balk, J., Day, R., Rosenzweig, M., & Beriwal, S. (2009). Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue. Journal of the Society for Integrative Oncology, 7, 4–11.

To obtain feasibility and effect size data for the intervention of true acupuncture on cancer-related fatigue (CRF) in patients receiving radiation therapy.

Participants were randomized to receive acupuncture or sham acupuncture; there were three real intervention assignments for every two sham assignments. Needles were in place for 30 minutes per session, and participants had treatments once or twice per week during the four to six weeks of the trial. Needle placement for true and sham interventions were specifically described in the report.

• In total, 27 females receiving radiation therapy completed the study:  11 were randomized to the sham procedure and 16 were randomized to acupuncture.
• Mean age was 54.1 years (standard deviation = 9.4 years).
• All but one participant had breast cancer.
• Of the sample, 44% had also received chemotherapy (74% of the acupuncture group versus 44% of the sham group).

• Single site
• Magee Womens’ Hospital, Pittsburgh, PA

The study was a double-blind, placebo-controlled, randomized trial.

• The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale was measured at baseline and three, six, and 10 weeks.
• Quality of life (QOL) was measured with the Short Form 36 (SF-36) Health Survey at baseline and six and 10 weeks.
• The Cancer-Related Fatigue Distress Scale (CRFDS) was measured at baseline and six and 10 weeks.
• Confounding variables measured included:  Brief Symptom Inventory (BSI-18) and Center for Epidemiologic Studies Depression Scale (CEDS).

FACIT-F scores in the true acupuncture group improved more over time than those in the sham group, but the differences were not significant. QOL and depression scores improved in both groups over time significantly but were not different between the groups. Observations regarding feasibility during the study included:  there was difficulty getting patients enrolled; changes in staff, staffing, and procedures made protocol use difficult; and due to procedures to maintain blinding and use of sham procedures, therapists felt that there was less needle manipulation possible with the protocol used for true acupuncture and felt it was difficult to determine the actual depth of needle insertion. It was also felt that the sham procedure was actually more than sham, although less than true acupuncture, due to skin and pressure stimulation.

It was concluded that feasibility to conduct this type of trial in a large group of patients was low. Findings of this study did not support the use of acupuncture to reduce fatigue in patients receiving radiation therapy.

• The study had a small sample size.
• It was not clear, or discussed, how many patients in either group received one or two sessions per week during the trial or whether any differences were associated with the frequency of treatment.
• It was noted that the sham/placebo control procedures were inadequate to provide a true control.
• There was no standard care comparison group.
• Improvements in fatigue, QOL, and depression over time may have been associated with increased attention from trial participation rather than any effect from study interventions.
• The study was not sufficiently powered, and the sample size was too small to differentiate between the groups and identify the associated effect size.