RecruitingRecruiting
Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
NCT04997096 · Dana-Farber Cancer Institute
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
This research study is a randomized controlled trial that will compare an exercise group to a control group on lower extremity function, CIPN, and inflammatory markers in ovarian or endometrial cancer patients undergoing first-line chemotherapy after surgery.
The names of the study interventions involved in this study are/is:
* Aerobic and resistance exercise; virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom
* Attention control for 16 weeks, home-based stretching
The research study procedures include: screening for eligibility and study interventions including evaluations and follow up visits.
It is expected that about 30 people will take part in this research study.
Eligibility criteria
Inclusion Criteria:
* Newly diagnosed patients with stages III-IV ovarian or endometrial cancer
* Receiving first-line carboplatin and paclitaxel chemotherapy after surgery
* ≥18 years, children under the age of 18 will be excluded due to rarity of disease
* Physician's clearance to participate in moderate-vigorous intensity exercise
* Able to read, write, and understand English
* Ability to understand and the willingness to sign an informed consent document
* Willing to undergo two venous blood draws for the study
Exclusion Criteria:
* Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist
* Participants with uncontrolled intercurrent illness, as determined by the treating oncologist
* Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating oncologist
* Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)
Study design
Enrollment target: 30 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-04-02
Estimated completion: 2029-04-30
Last updated: 2026-02-19
Interventions
Other: ExerciseOther: Attention Control
Primary outcomes
- • Proportion of patients completing the exercise intervention sessions. (16 Weeks)
- • Enrollment Rate (16 Weeks)
Sponsor
Dana-Farber Cancer Institute · other
Contacts & investigators
ContactChristina Dieli-Conwright, PhD · contact · ChristinaM_Dieli-Conwright@dfci.harvard.edu · (617) 582-8321
InvestigatorChristina Dieli-Conwright, PhD · principal_investigator, Dana-Farber Cancer Institute
All locations (1)
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States