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

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: Exercise
* Other: Attention Control


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Participants randomized to one of two groups with 2:1 ratio: exercise (n=20) - Aerobic and Resistance Exercise for 16 weeks | Other: Exercise<br>* 16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery<br>|
| Active Comparator: Attention Control<br>Participants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching | Other: Attention Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients completing the exercise intervention sessions. | The feasibility of the 16-week exercise intervention is defined as the proportion of patients completing the exercise intervention sessions. The analysis population will be the eligible patients who are assigned to the intervention group (N=20). The investigators will estimate the proportion and corresponding 95% exact confidence interval (CI).99 The Investigators expect that the proportion is 70% or higher | 16 Weeks | 
| Enrollment Rate | The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment. | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB)-Lower Extremity Function | Short Physical Performance Battery (SPPB), an objective measure of lower-extremity function based on three timed tests of standing balance, walking speed, and chair stand tests, which in older adults is predictive of disability, nursing home admission, and all-cause mortality | 16 Weeks | 
| Change in 6-minute walk distance | Aerobic fitness will be assessed by the 6-minute walk test (6MWT). The 6MWT has been administered in cancer survivors and has a reliability coefficient of 0.93 when tested in cancer survivors. Participants will be instructed to walk as quickly as possible without running on an indoor pre-measured walkway for 6 minutes | 16 weeks | 
| PROMIS- Physical function | Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale. | 16 Weeks | 
| Number of Participants with Treatment Related Adverse Events | NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. | 16 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer, Aerobic Exercise, Strength Training, Cardiovascular training