Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise, Attention Control.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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).
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.
Interventions
- Other Exercise
16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery - Other Attention Control
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.
Primary outcome measures
- Proportion of patients completing the exercise intervention sessions. [Time frame: 16 Weeks]
- Enrollment Rate [Time frame: 16 Weeks]
Secondary outcome measures (4)
- Short Physical Performance Battery (SPPB)-Lower Extremity Function [Time frame: 16 Weeks]
- Change in 6-minute walk distance [Time frame: 16 weeks]
- PROMIS- Physical function [Time frame: 16 Weeks]
- Number of Participants with Treatment Related Adverse Events [Time frame: 16 Weeks]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Dana Farber Cancer Institute — Boston
Identifiers
NCT: NCT04997096 · 21-299