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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Endometrial Cancer; Ovarian Cancer Stage 3; Endometrial Cancer Stage; Ovarian Cancer Stage IV; Ovarian Cancer Stage III; Ovarian Carcinoma; Ovarian Cancer

Treatments: Other: Exercise; Other: Attention Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04997096

21-299

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Exercise

Experimental group

Description:

Participants randomized to one of two groups with 2:1 ratio: exercise (n=20) - Aerobic and Resistance Exercise for 16 weeks

Treatment:

Other: Exercise

Attention Control

Active Comparator group

Description:

Participants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching

Treatment:

Other: Attention Control