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NCT04997096 | RECRUITING | Ovarian Cancer

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

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Christina Pieli-Conwright, PhD

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).

Condition or disease

Ovarian Cancer

Ovarian Carcinoma

Ovarian Cancer Stage IV

Ovarian Cancer Stage III

Ovarian Cancer Stage 3

Endometrial Cancer

Endometrial Cancer Stage

Intervention/treatment

Exercise

Attention Control

Phase

NA

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
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
Actual Study Start Date : 2022-04-02
Estimated Primary Completion Date : 2026-02-01
Estimated Study Completion Date : 2026-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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)
Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy

Location Details

NCT04997096

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215