This phase II trial studies the effect of acupuncture on cancer-related cognitive difficulties and insomnia in stage 0-III breast cancer survivors. 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 can also improve the cognitive difficulties and insomnia that many cancer survivors report following chemotherapy and other cancer treatments. There is also some evidence that fixing sleep problems can improve some cognitive functions, such as memory and concentration. This study may provide researchers with useful information about acupuncture’s effects on both cognitive function and insomnia. The study may also give researchers better insight into the connection between insomnia and cognitive difficulties.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04837820.
PRIMARY OBJECTIVE:
I. To determine the effects of acupuncture on perceived cancer-related cognitive difficulties (CRCD) and objective cognitive function.
SECONDARY OBJECTIVES:
I. To evaluate the mechanism of acupuncture on perceived CRCD and objective cognition function via brain-derived neurotrophic factor (BDNF) or other potential biomarkers.
II. To elucidate the role of insomnia on perceived CRCD and objective cognitive function in the context of acupuncture.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I (ACUPUNCTURE): Patients undergo acupuncture treatments once weekly over 10 weeks. Patients also complete questionnaires and neurocognitive assessments on study.
ARM II (SHAM ACUPUNCTURE): Patients undergo sham acupuncture treatments once weekly over 10 weeks. Patients also complete questionnaires and neurocognitive assessments on study.
ARM III (WAIT-LIST CONTROL): Patients undergo standard of care treatment over 26 weeks. Patients also complete questionnaires and neurocognitive assessments on study. Within 6 months of study completion, patients may undergo acupuncture treatments over 10 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJun J. Mao
