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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Eligibility

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

NCT04997096

Dana-Farber Cancer Institute

26 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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