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Exercise Intervention for Breast Cancer-Related Inflammation (DECODE Trial)
N/A
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (≥ 18 years) assigned female sex at birth
Diagnosed with invasive non-metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t1 (baseline), t2 (18-24 weeks), and t3 (12 months)
Awards & highlights
DECODE Trial Summary
This trial is looking at how cancer drugs impact the vascular system and whether or not exercise can help offset some of those changes.
Who is the study for?
This trial is for adults assigned female at birth, diagnosed with non-metastatic breast cancer, receiving certain chemotherapy including anthracyclines or anti-Her2 therapy. Participants must be able to exercise safely and identify as Black/African American or non-Hispanic White. Excluded are those who don't speak English, have metastatic disease, are pregnant/lactating, have cardiovascular disease, prior similar treatments or significant recent weight loss.Check my eligibility
What is being tested?
The study tests the 'Taking Charge during Treatment' (TCT) Intervention aimed at understanding how cancer treatment-induced inflammation affects blood vessel function and if exercise can mitigate these effects. It uses advanced -omics technologies to predict microvascular dysfunction from chemotherapy.See study design
What are the potential side effects?
While specific side effects of the TCT Intervention aren't detailed here, potential risks may include typical reactions to moderate exercise and strength training such as muscle soreness or strain.
DECODE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult woman.
Select...
I have been diagnosed with breast cancer that has not spread.
DECODE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ t1 (baseline), t2 (18-24 weeks), and t3 (12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~t1 (baseline), t2 (18-24 weeks), and t3 (12 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximal Exercise: Maximal oxygen consumption will be evaluated using cycle ergometry or treadmill to exhaustion as described in the Integrative Physiology Laboratory at each testing visit.
Secondary outcome measures
Assess mitochondrial DNA damage
Cardiac function - Echocardiagram
Cardiac function - Pulse Wave Velocity
+12 moreOther outcome measures
6 Minute Walk Test
Accelerometry
DEXA Scan
+6 moreDECODE Trial Design
2Treatment groups
Active Control
Group I: Taking Charge during Treatment (TCT) InterventionActive Control1 Intervention
Taking Charge during Treatment (TCT) Intervention. TCT is a 16-20week intervention that promotes adoption of the ACSM exercise guidelines for cancer survivors during treatment, including regular moderate to vigorous physical activity (150 minutes per week of moderate activity or 75 minutes per week of vigorous activity) and a minimum of twice weekly resistance training (RT) minutes during CTx and after. Participants will receive "Take Charge" program binder, 2-4 x weekly text messaging, activity tracker and resistance bands.
Group II: Control GroupActive Control1 Intervention
To ensure scientific rigor allowing us to test causal pathways associated with exercise, women will be randomized to the TCT intervention or control group arm. The control group will not receive the TCT intervention The investigators experience teaches us that to increase the likelihood of retaining control group participants, the investigators must offer some resources. Thus, the investigators will provide the control group with a one-page summary of the American College of Sports Medicine exercise recommendations, and the "Take Charge" program binder at the completion of the study. Participants will also receive resistance bands and activity tracker at the end of the study. 95 The investigators will also send weekly text messages with supportive content not related to exercise or lifestyle (i.e., a riddle, "take a moment to smile today," a picture of a baby animal).
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,503 Total Patients Enrolled
13 Trials studying Breast Cancer
409,263 Patients Enrolled for Breast Cancer
University of Illinois at ChicagoOTHER
609 Previous Clinical Trials
1,559,229 Total Patients Enrolled
10 Trials studying Breast Cancer
1,342,276 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am undergoing treatment for breast cancer that includes specific chemotherapy drugs or targeted therapy.I have heart disease with symptoms or an ejection fraction below 50%.I am an adult woman.I have had chemotherapy or targeted head and neck cancer treatment before.I have been diagnosed with breast cancer that has not spread.My doctor says I can safely do moderate exercise and strength training.I have lost more than 10% of my weight without trying in the last 6 months.My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Taking Charge during Treatment (TCT) Intervention
- Group 2: Control Group
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.
How many participants have been enlisted in this research endeavor?
"Affirmative. The information hosted on clinicaltrials.gov attests that this medical study, first published on March 1st 2022, is presently recruiting patients. In total, 80 volunteers across two research sites are required for the trial's completion."
Answered by AI
What type of individual is best suited to participate in this trial?
"To be eligible for this research project, breast cancer patients must fit within the parameters of 18 to 100 years old. The trial is currently recruiting around 80 volunteers."
Answered by AI
Is this research recruiting participants at the moment?
"Still recruiting, the trial was published on March 1st 2022 and has seen its most recent update on April 11th of the same year. All information is hosted on clinicaltrials.gov."
Answered by AI
Is the minimum age requirement for this research 55 years or less?
"In order to be accepted into this medical trial, a person must meet the age requirement of 18 and not exceed 100 years old."
Answered by AI
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