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Chemotherapy

ADDENDUM: Physical Activity Intervention for Breast Cancer

N/A
Waitlist Available
Led By William Hundley
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after treatment initiation
Awards & highlights

Study Summary

MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum

Eligible Conditions
  • Breast Cancer
  • Cancer
  • Cardiac Toxicity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after treatment initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)
Number of Participants Completing the Trial (Exercise Capacity Addendum)
Secondary outcome measures
6-minute Walk Distance (Exercise Capacity Addendum)
Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)
Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: MRI (Diagnostic)Experimental Treatment3 Interventions
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Group II: ADDENDUM: Physical Activity InterventionExperimental Treatment4 Interventions
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Group III: ADDENDUM: Healthy Living Instruction Group (Control Arm)Experimental Treatment4 Interventions
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic resonance imaging
2016
Completed Phase 3
~1240
Cardiopulmonary Exercise Testing (CPET)
2013
N/A
~60

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,155 Total Patients Enrolled
32 Trials studying Breast Cancer
5,012 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,125 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,332 Patients Enrolled for Breast Cancer
William HundleyPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
38 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
2013. "MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01719562.
~2 spots leftby Apr 2025
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