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

Primary Purpose

Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise

Attention Control

About this trial

This is an interventional supportive care trial for Ovarian Cancer focused on measuring Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer, Aerobic Exercise, Strength Training, Cardiovascular training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Attention Control

Arm Description

Participants randomized to one of two groups with 2:1 ratio: exercise (n=20) - Aerobic and Resistance Exercise for 16 weeks

Participants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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

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

PROMIS- Physical function

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

NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Full Information

NCT ID

NCT04997096

First Posted

August 4, 2021

Last Updated

February 16, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04997096

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 2, 2022 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Ovarian Cancer, Ovarian Carcinoma, Ovarian Cancer Stage IV, Ovarian Cancer Stage III, Ovarian Cancer Stage 3, Endometrial Cancer, Aerobic Exercise, Strength Training, Cardiovascular training

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Participants randomized to one of two groups with 2:1 ratio: exercise (n=20) - Aerobic and Resistance Exercise for 16 weeks

Arm Title

Attention Control

Arm Type

Active Comparator

Arm Description

Participants randomized to one of two groups with attention control (n=10). -Attention Control for 16 weeks home-based stretching

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery

Intervention Type

Other

Intervention Name(s)

Attention Control

Intervention Description

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 Measure Information:

Title

Proportion of patients completing the exercise intervention sessions.

Description

Time Frame

16 Weeks

Title

Enrollment Rate

Description

The enrollment rate is defined as the proportion of patients who participate in the study among those patients who are approached for the enrollment.

Time Frame

16 Weeks

Secondary Outcome Measure Information:

Title

Short Physical Performance Battery (SPPB)-Lower Extremity Function

Description

Time Frame

16 Weeks

Title

Change in 6-minute walk distance

Description

Time Frame

16 weeks

Title

PROMIS- Physical function

Description

Physical function will be assessed using the Patient Reported Outcome Measure Information System (PROMIS) Physical Function-10 scale.

Time Frame

16 Weeks

Title

Number of Participants with Treatment Related Adverse Events

Description

NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Time Frame

16 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christina Dieli-Conwright, PhD

Phone

(617) 582-8321

ChristinaM_Dieli-Conwright@dfci.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Dieli-Conwright, PhD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christina Dieli-Conwright, PhD, MPH

Phone

617-582-8321

ChristinaM_Dieli-Conwright@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Mary Norris, MS

Phone

857-215-0195

maryk_norris@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Christina Dieli-Conwright, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

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

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