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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997096
• Other study ID #: 21-299
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: Christina Dieli-Conwright, PhD
• Phone: (617) 582-8321
• Email: ChristinaM_Dieli-Conwright[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV
• Ovarian Carcinoma
• Ovarian Neoplasms

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
• 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.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	PROMIS- Physical function	Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.	16 Weeks
Secondary	Number of Participants with Treatment Related Adverse Events	NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.	16 Weeks