This phase II trial studies how well acupuncture works in improving cognitive difficulties in cancer survivors. Some treatments used for cancer can cause long-term side effects, such as cognitive difficulties. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. It has been widely used to treat pain, but researchers think acupuncture may help improve the cognitive difficulties and insomnia that many cancer survivors report following chemotherapy and other cancer treatments.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04007770.
PRIMARY OBJECTIVE:
I. To obtain preliminary data on the magnitude of effect of an acupuncture intervention to improve perceived cognitive difficulties (CD) among cancer survivors.
SECONDARY OBJECTIVES:
I. To obtain preliminary data on the magnitude of effect of an acupuncture intervention to improve insomnia among cancer survivors.
II. To evaluate the association between sleep- and cognition-related outcomes.
III. To evaluate the safety of acupuncture for perceived CD and insomnia in cancer survivors.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo acupuncture over 30-45 minutes once weekly for up to 10 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16.
GROUP II: Patients undergo sham acupuncture over 30-45 minutes once weekly for up to 10 weeks. Patients also complete a sleep diary daily for 7 consecutive days on weeks 0, 10, and 16. After 16 weeks, patients have the option to receive up to sessions of real acupuncture, to be completed within 6 months of end of the study.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJun J. Mao