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

• ClinicalTrials.gov Identifier: NCT04997096
• Recruitment Status: Recruiting
• First Posted: August 9, 2021
• Last Update Posted: February 21, 2024
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: August 4, 2021
• First Posted Date: August 9, 2021
• Last Update Posted Date: February 21, 2024
• Actual Study Start Date: April 2, 2022
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2022)

• Proportion of patients completing the exercise intervention sessions. [ Time Frame: 16 Weeks ]
  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
• Enrollment Rate [ Time Frame: 16 Weeks ]
  The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.

Original Primary Outcome Measures (submitted: August 4, 2021)

• Proportion of patients completing the exercise intervention sessions. [ Time Frame: 16 Weeks ]
  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). We will estimate the proportion and corresponding 95% exact confidence interval (CI).99 We expect that the proportion is 70% or higher
• Enrollment Rate [ Time Frame: 16 Weeks ]
  The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.

Current Secondary Outcome Measures (submitted: August 4, 2021)

• Short Physical Performance Battery (SPPB)-Lower Extremity Function [ Time Frame: 16 Weeks ]
  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
• Change in 6-minute walk distance [ Time Frame: 16 weeks ]
  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
• PROMIS- Physical function [ Time Frame: 16 Weeks ]
  Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.
• Number of Participants with Treatment Related Adverse Events [ Time Frame: 16 Weeks ]
  NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
• Official Title: Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
• 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).

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Ovarian Cancer
• Ovarian Carcinoma
• Ovarian Cancer Stage IV
• Ovarian Cancer Stage III
• Ovarian Cancer Stage 3
• Endometrial Cancer
• Endometrial Cancer Stage

Intervention

• 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.

Study Arms

• Experimental: Exercise

  Participants randomized to one of two groups with 2:1 ratio: exercise (n=20)

  - Aerobic and Resistance Exercise for 16 weeks

  Intervention: Other: Exercise
• Active Comparator: Attention Control

  Participants randomized to one of two groups with attention control (n=10).

  -Attention Control for 16 weeks home-based stretching

  Intervention: Other: Attention Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 4, 2021): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2025
• Estimated Primary Completion Date: February 1, 2025 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christina Dieli-Conwright, PhD; (617) 582-8321; ChristinaM_Dieli-Conwright@dfci.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04997096
• Other Study ID Numbers: 21-299
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (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

• Current Responsible Party: Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christina Dieli-Conwright, PhD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: February 2024