Cancer-related
fatigue is a substantial problem for
cancer patients and their caregivers, but no effective treatment exists. Acupuncture has been suggested to improve
cancer-related
fatigue, but no randomized clinical trials have been conducted. We hypothesized that true acupuncture, compared with
sham acupuncture, would reduce
cancer-related
fatigue in
cancer patients receiving external
radiation therapy. The aim of this study was to determine effect size and feasibility. A modified, double-blind, randomized, placebo-controlled trial was conducted. The subject, clinical staff, and assessor were blinded, but the acupuncturist was not. Subjects received acupuncture once to twice per week during the 6-week course of
radiation therapy. Data were collected at baseline, 3 weeks, 6 weeks, and 10 weeks, which was 4 weeks after that last radiation session. Twenty-seven subjects enrolled, and 23 completed the last data collection. Both true and
sham acupuncture groups had improved
fatigue,
fatigue distress, quality of life, and depression from baseline to 10 weeks, but the differences between the groups were not statistically significant. The true acupuncture group improved 5.50 (SE, +/- 1.48) points on the Functional Assessment of
Chronic Illness Therapy-
Fatigue Subscale (FACIT-F), whereas the
sham acupuncture group improved by 3.73 (SE +/- 1.92) points. This difference was not statistically significant (p = .37). All subjects guessed that they were in the true acupuncture group. Our study was underpowered to find a statistically significant difference. To demonstrate a statistically significant improvement between true and
sham acupuncture would require 75 subjects per group in a future study. Owing to poor recruitment, the feasibility of a larger trial using the same methodology is low. Despite being underpowered, it appears that subjects receiving true acupuncture may benefit more than subjects receiving
sham acupuncture. In the discussion section, we review our experience with using a
sham-needle controlled study.