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

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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Ovarian Carcinoma Ovarian Cancer Stage IV Ovarian Cancer Stage III Ovarian Cancer Stage 3 Endometrial Cancer Endometrial Cancer Stage Other: Exercise Other: Attention Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy
Actual Study Start Date : April 2, 2022
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise

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

- Aerobic and Resistance Exercise for 16 weeks

 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
Active Comparator: Attention Control

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

-Attention Control for 16 weeks home-based stretching

 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. Number of Participants with Treatment Related Adverse Events [ Time Frame: 16 Weeks ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997096


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

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christina Dieli-Conwright, PhD, MPH    617-582-8321    ChristinaM_Dieli-Conwright@dfci.harvard.edu   
Contact: Mary Norris, MS    857-215-0195    maryk_norris@dfci.harvard.edu   
Principal Investigator: Christina Dieli-Conwright, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Christina Dieli-Conwright, PhD Dana-Farber Cancer Institute
More Information
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Responsible Party: Christina Dieli-Conwright, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04997096    
Other Study ID Numbers: 21-299
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024
Individual Participant Data (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
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute:
Ovarian Cancer
Ovarian Carcinoma
Ovarian Cancer Stage IV
Ovarian Cancer Stage III
Ovarian Cancer Stage 3
 Endometrial Cancer
Aerobic Exercise
Strength Training
Cardiovascular training
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endometrial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Diseases