Recruiting

Exercise

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04997096

Conditions

Ovarian Cancer

Ovarian Carcinoma

Ovarian Cancer Stage IV

Ovarian Cancer Stage III

Ovarian Cancer Stage 3

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Attention Control

Study Details

Brief summary:

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).

Conditions

Ovarian Cancer

Ovarian Carcinoma

Ovarian Cancer Stage IV

Ovarian Cancer Stage III

Ovarian Cancer Stage 3

Study ID

NCT04997096

Start date

Apr 2, 2022

Status verified date

Feb, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exercise

Participants randomized to one of two groups with 2:1 ratio: exercise (n=20)

\- Aerobic and Resistance Exercise for 16 weeks

active comparator: Attention Control

Participants randomized to one of two groups with attention control (n=10).

-Attention Control for 16 weeks home-based stretching

Interventions

Exercise

16-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

Home-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.

Primary outcome measure

  • Proportion of patients completing the exercise intervention sessions. [ Time Frame: 16 Weeks ]
  • Enrollment Rate [ Time Frame: 16 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Christina Dieli-Conwright, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Ovarian Cancer
  • Ovarian Carcinoma
  • Ovarian Cancer Stage IV
  • Ovarian Cancer Stage III
  • Ovarian Cancer Stage 3
  • Endometrial Cancer
  • Aerobic Exercise
  • Strength Training
  • Cardiovascular training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-02-19.