This clinical trial evaluates whether electroacupuncture (EA) can be used to help manage cognitive impairment, fatigue, insomnia, and psychological distress in cancer patients and survivors. Many survivors of cancer often experience a range of physical symptoms and psychosocial burden throughout and after chemotherapy treatment, of which fatigue, cognitive impairment, insomnia, and psychological distress are often the most prevalent. Non-pharmacological methods, like electroacupuncture, have been considered as potential treatment options for these symptoms. Electroacupuncture is a procedure in which pulses of weak electrical current are sent through acupuncture needles into acupuncture points in the skin. This clinical trial evaluates whether electroacupuncture to disease-related therapeutic acu-points helps manage these symptoms in cancer patients and survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05283577.
PRIMARY OBJECTIVES:
I. To compare the efficacy of EA versus sham-EA control in reducing cognitive toxicity, fatigue, psychological distress, insomnia, and to improve quality of life.
II. To evaluate the impact of EA versus sham-EA control on biomarkers, including circulating brain-derived neutropic factor (BDNF), pro-inflammatory cytokines (IL-1beta, IL-4, IL-6, IL-8, IL-10, tumor necrosis factor [TNF]-alpha), mitochondrial deoxyribonucleic acid (DNA) (oxidative stress indicator).
III. To compare the reduction of structural (brain gray matter) and functional connectivity at the prefrontal, medial temporal, and parietal brain regions pre- and post-EA treatment.
IV. To assess the safety and feasibility of administering EA to manage symptom clusters in cancer patients and survivors.
V. As the University of California Irvine (UCI) Memory Impairments and Neurological Disorders (MINDS) consent-to-contact (C2C) registry (UCI institutional review board [IRB] Approval #: HS# 2015-2494) will be leveraged to recruit some patients, will quantify the characteristics associated with non-response to our study advertisement among C2C registrants using C2C-collected data.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo electroacupuncture to disease-related therapeutic acu-points weekly over 1 hour for 10 weeks. Patients undergo collection of blood samples at baseline, 5 weeks, 10 weeks, and 4 weeks after treatment end. Patients may optionally undergo magnetic resonance imaging (MRI) at baseline and end of treatment.
ARM II: Patients undergo electroacupuncture to non-disease-related acu-points weekly over 1 hour for 10 weeks. Patients undergo collection of blood samples at baseline, 5 weeks, 10 weeks, and 4 weeks after treatment end. Patients may optionally undergo MRI at baseline and end of treatment.
After completion of study treatment, patients are followed up at 4 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorAlexandre Chan
