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Exercise During Chemotherapy for Breast Cancer
N/A
Waitlist Available
Led By Meghan Karuturi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 month after chemotherapy
Awards & highlights
Study Summary
This trial is testing if it's feasible for older women with breast cancer to exercise during chemotherapy. Researchers hope this will help reduce the chemotherapy-toxicity risk.
Who is the study for?
This trial is for women aged 65 or older with Stage I-III breast cancer, about to start chemotherapy. They must be able to walk, do moderate exercise, and commit to the study's requirements. Women with serious medical conditions that prevent them from exercising cannot participate.Check my eligibility
What is being tested?
The trial tests if it's practical for older women receiving chemotherapy for breast cancer to follow an exercise program. It includes questionnaires, discussions, using a medical device, quality-of-life assessments, and educational interventions about physical activity.See study design
What are the potential side effects?
Since this trial focuses on the feasibility of exercise during treatment rather than medication side effects, specific side effects are not listed. However, participants may experience general fatigue or discomfort associated with increased physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 month after chemotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month after chemotherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence
Compliance
Retention
Secondary outcome measures
Geriatric assessment
Incidence of adverse events (AEs)
Outcome Expectations for Exercise (OEE) Scale Questionnaires
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (coaching, exercise, questionnaire)Experimental Treatment6 Interventions
Patients participate in one-on-one coaching sessions with a health coach QW to discuss the content offered in the program, and challenges they are currently facing in achieving their exercise goals. Patients receive a copy of the WWE workbook, wear a fitness tracker and are encouraged to achieve 150 minutes of walking per week during chemotherapy and up to 1 month after chemotherapy. Patients also participate in the Growing Stronger Strength Training Program and receive instruction manuals. They perform the initial 2 exercises 2 days per week for 4 weeks, and subsequent 2 exercises 2 days per week for the remainder of the chemotherapy course. Patients maintain exercise logs and complete questionnaires over 30-45 minutes at baseline, end of chemotherapy and at 1 month after chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Discussion
2021
N/A
~130
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,772 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Meghan KaruturiPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
142 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a woman who is 65 years old or older.You have been diagnosed with Stage I, II, or III breast cancer. If you have had more than one diagnosis, we will consider the most recent one.You can walk and do moderate physical activities on your own.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (coaching, exercise, questionnaire)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the projected effects of this medical investigation?
"The primary end point of this clinical trial, measured up to one month after chemotherapy, is patient adherence. Secondary outcomes include Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM) questionnaires which are assessed using Wilcoxon signed rank tests; Geriatric assessment measures also evaluated by a Wilcoxon signed rank test; and the Short Physical Performance Battery (SPPB), again analysed through a Wilcoxon signed rank test. PSEFSM 35-36 is an 6 item scale with responses ranging from "not at all confident" to "total confident"."
Answered by AI
Are there any remaining slots for potential participants of this trial?
"According to clinicaltrials.gov, the study is currently open for enrollment and was first published on December 3rd 2020 with its most recent modification occurring September 22nd 2022."
Answered by AI
How many volunteers have signed up for this investigation?
"Affirmative. The clinicaltrials.gov database confirms that the trial, initially posted in December 3rd 2020, is still seeking participants. Approximately 30 individuals are needed at a single medical centre."
Answered by AI
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