This clinical trial evaluates the feasibility of a virtually supervised aerobic and resistance exercise program in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer. Exercise may help improve lower extremity function (function of the legs) and lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet) in patients receiving chemotherapy after surgery for ovarian or endometrial cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04997096.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Christina Dieli-Conwright
Phone: 617-582-8321
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of the exercise intervention.
SECONDARY OBJECTIVES:
I. To evaluate the effects of a 16-week, technology-enabled exercise intervention on lower extremity function, compared with an attention control group, at enrollment and 18-weeks.
II. To evaluate the effects of a 16-week, technology-enabled exercise intervention on chemotherapy induced peripheral neuropathy (CIPN) in patients receiving chemotherapy for ovarian or endometrial cancer at enrollment and 18-weeks.
EXPLORATORY OBJECTIVES:
I. To explore associations between biomarkers, CIPN, and lower extremity function at baseline and after the 16-week technology-enabled exercise intervention in patients receiving chemotherapy for ovarian or endometrial cancer.
II. To determine the effects of a 16-week technology-enabled exercise intervention on executive functioning and memory in 40 ovarian or endometrial cancer patients undergoing chemotherapy.
III. To evaluate the effect of a 16-week, technology-enabled intervention, on relative dose intensity of chemotherapy, immunotherapy, and radiation therapy in patients receiving chemotherapy for ovarian or endometrial cancer.
IV. To evaluate the effect of a 16-week, technology-enabled intervention, on dose modifications in oncological treatment in patients receiving chemotherapy for ovarian or endometrial cancer.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Beginning 4 weeks after surgery, patients participate in virtually supervised aerobic and resistance exercise at home via Zoom over 45-90 minutes 3 days per week for 16 weeks. Patients also undergo collection of blood samples on study and during follow up.
GROUP B: Patients participate in stretching program at home 3 days per week for 16 weeks. Patients also undergo collection of blood samples on study and during follow up.
After completion of study intervention, patients are followed up for 4 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorChristina Dieli-Conwright
