This pilot randomized clinical trial compares the effectiveness of yoga on reducing symptoms caused by chemotherapy-induced nerve damage in stage I-III breast, ovarian, uterine, or endometrial cancer survivors. Yoga may help relieve pain and reduce symptoms from peripheral neuropathy caused by chemotherapy in breast cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03292328.
PRIMARY OBJECTIVES:
I. To determine preliminary data on safety, feasibility, and effectiveness of yoga on reducing chemotherapy-induced peripheral neuropathy (CIPN) symptoms measured by the primary end point, which is patients' CIPN symptom ratings (tingling, numbness, and pain) on the 0-10 numeric rating scale at 8 weeks, and improving balance and fall prevention to help design the follow up adequately powered randomized controlled trial (RCT).
SECONDARY OBJECTIVES:
I. To elucidate the mechanisms of yoga by obtaining estimates of tactile threshold, vibration threshold, thermal threshold and conditioned pain modulation in the context of a trial of yoga for CIPN.
II. To obtain estimates of the change in yoga self-efficacy, insomnia, anxiety, depression, and fatigue symptoms.
III. To obtain estimates of the correlation of treatment expectancy and treatment response among those randomized to the yoga treatment arm.
IV. To obtain estimates of the change in CIPN severity and quantitative sensory testing (QST) measurements.
V. To explore the feasibility and adherence to a weekly onsite yoga maintenance program.
VI. To establish QST characteristics in cancer survivors without CIPN.
OUTLINE: Patients are randomized to 1 of 2 groups. Patients without CIPN are assigned to group 3.
GROUP I (YOGA TREATMENT): Patients participate in yoga classes lasting approximately 1 hour each twice a week for 8 weeks and at home practice for 1 hour on the days when classes are not held for 12 weeks. Patients then continue with a home-based-only program for the following 4 weeks.
GROUP II (WAIT LIST CONTROL): Patients receive standard medical care as prescribed by their physicians or other health care providers for 12 weeks. Patients then participate in yoga classes lasting approximately 1 hour each twice a week and at home practice for 1 hour on the days when classes are not held for 8 weeks.
GROUP III (CONTROL GROUP): Patients receive standard medical care as prescribed by their physician or other health care provider.
After completion of study treatment, patients are followed up at weeks 4, 8, 12, and 20 (Group II only).
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorTing Bao