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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    30
  • sponsor
    Dana-Farber Cancer Institute
Updated on 14 May 2022
paclitaxel
cancer
carboplatin
neuropathy
cancer chemotherapy

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).

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.

Details
Condition Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer, Endometrial Cancer Stage
Treatment Exercise, Attention Control
Clinical Study IdentifierNCT04997096
SponsorDana-Farber Cancer Institute
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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