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

NCT ID: NCT04997096

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-02

Study Completion Date

2026-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Ovarian Cancer Ovarian Carcinoma Ovarian Cancer Stage IV Ovarian Cancer Stage III Ovarian Cancer Stage 3 Endometrial Cancer Endometrial Cancer Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise

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

\- Aerobic and Resistance Exercise for 16 weeks

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

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

-Attention Control for 16 weeks home-based stretching

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type OTHER

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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Christina Dieli-Conwright, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Dieli-Conwright, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christina Dieli-Conwright, PhD

Role: CONTACT

(617) 582-8321

Facility Contacts

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Christina Dieli-Conwright, PhD, MPH

Role: primary

617-582-8321

Mary Norris, MS

Role: backup

857-215-0195

Other Identifiers

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21-299

Identifier Type: -

Identifier Source: org_study_id

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