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Behavioral Intervention

Exercise Training for Breast Cancer

N/A
Recruiting
Led By Demetra Christou, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test whether an exercise intervention can help breast cancer patients undergoing chemotherapy avoid cardiovascular problems.

Who is the study for?
This trial is for women aged 18-85 with primary invasive non-metastatic breast cancer (stages I-III) who are about to start chemotherapy. Participants must be able to exercise, give consent, and not have severe lymphedema or cardiovascular diseases. It's not for those already doing a lot of aerobic exercise or involved in other experimental studies.Check my eligibility
What is being tested?
The study tests whether a special exercise program can protect the heart and blood vessels from damage during chemotherapy for breast cancer patients. The goal is to see if this can prevent future heart disease in these individuals.See study design
What are the potential side effects?
Since the intervention involves exercise training, potential side effects may include muscle soreness, fatigue, joint pain, and risk of injury. However, specific side effects will depend on each participant's health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with early-stage (I-III) breast cancer that has not spread.
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I am about to start specific chemotherapy before or after surgery.
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I am between 18 and 85 years old.
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I am female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in brachial artery FMD
Change in global longitudinal strain
Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: All-extremity exerciseExperimental Treatment1 Intervention
Group II: Treadmill exerciseActive Control1 Intervention
Group III: Usual CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise training
2019
Completed Phase 1
~1110

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,589 Total Patients Enrolled
13 Trials studying Breast Cancer
523 Patients Enrolled for Breast Cancer
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,789 Total Patients Enrolled
3 Trials studying Breast Cancer
555 Patients Enrolled for Breast Cancer
Demetra Christou, PhDPrincipal InvestigatorUniversity of Florida
7 Previous Clinical Trials
381 Total Patients Enrolled
1 Trials studying Breast Cancer
158 Patients Enrolled for Breast Cancer

Media Library

Exercise training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04914663 — N/A
Breast Cancer Research Study Groups: All-extremity exercise, Treadmill exercise, Usual Care
Breast Cancer Clinical Trial 2023: Exercise training Highlights & Side Effects. Trial Name: NCT04914663 — N/A
Exercise training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04914663 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this medical study limited to those under the age of eighty?

"This research trial is looking for participants who are between the ages of 30 and 85."

Answered by AI

How many individuals are authorized to partake in this clinical trial?

"Affirmative. Clinicaltrials.gov exhibits that this trial, which was initially uploaded on the 1st of January 2023, is currently recruiting for 68 patients at one site with a last edit made to it occurring on December 1st 2022."

Answered by AI

Is enrollment open for this medical experiment?

"This study is currently recruiting 68 individuals, aged 30 to 85 and diagnosed with primary invasive non-metastatic breast cancer (stages I-III). Essential requirements for participation include: no contraindications to exercise, clinician approval, capacity to give consent, commencement of neoadjuvant or adjuvant chemotherapy treatments that may involve anthracyclines, alkylating agents or taxanes. Furthermore, all candidates must provide written informed consent before the start of the trial."

Answered by AI

Is there still room to enroll individuals in this research program?

"Recent updates to clinicaltrials.gov suggest that this medical trial is actively enrolling participants since its initial posting on January 1st 2023 and subsequent edit on December 1st 2022."

Answered by AI
~34 spots leftby May 2024