Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy

February 17, 2026 updated by: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise

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

- Aerobic and Resistance Exercise for 16 weeks
Other: 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
Active Comparator: Attention Control

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

-Attention Control for 16 weeks home-based stretching
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients completing the exercise intervention sessions.
Time Frame: 16 Weeks
The feasibility of the 16-week exercise intervention is defined as the proportion of patients completing the exercise intervention sessions. The analysis population will be the eligible patients who are assigned to the intervention group (N=20). The investigators will estimate the proportion and corresponding 95% exact confidence interval (CI).99 The Investigators expect that the proportion is 70% or higher
16 Weeks
Enrollment Rate
Time Frame: 16 Weeks
The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.
16 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery (SPPB)-Lower Extremity Function
Time Frame: 16 Weeks
Short Physical Performance Battery (SPPB), an objective measure of lower-extremity function based on three timed tests of standing balance, walking speed, and chair stand tests, which in older adults is predictive of disability, nursing home admission, and all-cause mortality
16 Weeks
Change in 6-minute walk distance
Time Frame: 16 weeks
Aerobic fitness will be assessed by the 6-minute walk test (6MWT). The 6MWT has been administered in cancer survivors and has a reliability coefficient of 0.93 when tested in cancer survivors. Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes
16 weeks
PROMIS- Physical function
Time Frame: 16 Weeks
Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.
16 Weeks
Number of Participants with Treatment Related Adverse Events
Time Frame: 16 Weeks
NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Investigators

  • Principal Investigator: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2022

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

April 30, 2029

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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