Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable ovarian-cancer
Started Apr 2022
Longer than P75 for not_applicable ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedStudy Start
First participant enrolled
April 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2029
February 19, 2026
February 1, 2026
6.8 years
August 4, 2021
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Short Physical Performance Battery (SPPB)-Lower Extremity Function
16 Weeks
Change in 6-minute walk distance
16 weeks
PROMIS- Physical function
16 Weeks
Number of Participants with Treatment Related Adverse Events
16 Weeks
Study Arms (2)
Exercise
EXPERIMENTALParticipants randomized to one of two groups with 2:1 ratio: exercise (n=20) \- Aerobic and Resistance Exercise for 16 weeks
Attention Control
ACTIVE COMPARATORParticipants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching
Interventions
16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, PhD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 9, 2021
Study Start
April 2, 2022
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
April 30, 2029
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.