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Aerobic Training in Metastatic Breast Cancer

NCT01725633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-04-06

No results posted yet for this study

Summary

This study is being done to examine the safety and feasibility of a supervised progressive exercise program in women diagnosed with metastatic breast cancer. Previous research among women with metastatic breast cancer has shown that some of the treatments commonly used in this population may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects in women with early-stage breast cancer receiving common cancer treatments. However, it is not known if supervised exercise training is a safe and feasible intervention in women with metastatic breast cancer. This study is designed to find out if supervised exercise training is safe as the patients undergo treatments for metastatic breast cancer.

Conditions

Interventions

BEHAVIORAL

Progressive Stretching Group

Participants assigned to the progressive stretching group will be provided with a progressive stretching program that matches the aerobic training interventions in terms of program length (16 weeks), social interaction (all sessions will be supervised), and session duration (20-45 minutes/session, ± 10 minutes).

BEHAVIORAL

Nonlinear Aerobic Training

Participants assigned to the nonlinear aerobic training arm will perform no more than 150 minutes per week of structured supervised aerobic training as part of clinical trial participation. Exercise performed outside the structured sessions (i.e., contamination) will be assessed via self-report of exercise behavior using the Godin-Leisure Time Exercise Questionnaire (GLTEQ). For ethical reasons, we will not instruct participants not to exercise outside the structured sessions, but we we will encourage participants to maintain their level of exercise behavior prior to study initiation.

OTHER

Blood draw

At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.

OTHER

Cardiopulmonary Exercise Testing (CPET)

At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.

Sponsors & Collaborators

Principal Investigators

  • Lee Jones, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2023-04-04
Completion
2023-04-04

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01725633 on ClinicalTrials.gov