Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT04997096
- Status
- Recruiting
Conditions
- Endometrial Cancer
- Endometrial Cancer Stage
- Ovarian Cancer
- Ovarian Cancer Stage 3
- Ovarian Cancer Stage III
- Ovarian Cancer Stage IV
- Ovarian Carcinoma
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Exercise — OTHER16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery
- Attention Control — OTHERHome-based stretching program consisting of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. Participants will be shown how to use the booklet and instructed on how to complete the stretching exercises by an exercise trainer.
Study Details
The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).
Key Dates
- Start date
- Apr 2, 2022
- Status verified
- Feb 2026
- Primary completion
- Feb 1, 2029
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: ExerciseParticipants randomized to one of two groups with 2:1 ratio: exercise (n=20) \- Aerobic and Resistance Exercise for 16 weeks
- Active Comparator: Attention ControlParticipants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching
Primary Outcome Measure
Proportion of patients completing the exercise intervention sessions. [ Time Frame: 16 Weeks ]
Central Contacts
- Christina Dieli-Conwright, PhD(617) 582-8321
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Christina Dieli-Conwright, PhD (PRINCIPAL_INVESTIGATOR) |
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