The primary objective of this study is to test the efficacy of acupuncture for reducing sleep disruption in breast cancer survivors.
The secondary objectives of this study include:
• to provide preliminary data on the effects of acupuncture on fatigue and quality of life (QOL) in breast cancer survivors.
• to provide preliminary data on the effects of acupuncture on HPA axis hormones and cytokines in breast cancer survivors.
• to provide preliminary data on how sleep disruption, HPA axis hormones and cytokines in breast cancer survivors effect disease progression.
This study will recruit 64 women diagnosed with breast cancer who finished undergoing treatment and who also experience persistent insomnia problems. The eligible women will be randomized by sleep problems into one of two arms: (Acupuncture vs. Sham Acupuncture) with a goal of having 52 patients complete the study (we anticipate about 20% attrition rate). The placebo control for acupuncture is a validated sham acupuncture. Patients will complete daily diaries, questionnaires, saliva tests and blood draws. Data will be gathered via electronic and pencil-and-paper measures before, during, immediately following and one month following the completion of treatment. In addition, actigraphy data (objective sleep continuity data) will be acquired prior to, during and following treatment.
This study at Stanford University, in Calif., is investigating whether acupuncture can reduce sleep disruption and improve sleep in breast cancer survivors. The researchers wanted to enroll 64 volunteers. The Call to Action for this study was sent to Army of Women members on February 23, 2011. The researchers were able to close enrollment on May 16, 2012, after the Army of Women provided them with 170 women who were interested in enrolling in the study.