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Exercise for Breast Cancer Survivors
N/A
Recruiting
Led By Christina Dieli-Conwright, PhD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
Women newly diagnosed (Stage I-III) breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial will test whether exercise can help Latina breast cancer survivors by improving fitness and reducing risks for heart disease, diabetes, and obesity.
Who is the study for?
This trial is for Latina breast cancer survivors who are obese, have completed their main cancer treatments within the last year, and currently exercise less than 60 minutes a week. They must not smoke, be free from serious chronic diseases, agree to use contraception if applicable, and be willing to travel for the study.Check my eligibility
What is being tested?
The study tests whether Progressive Combined Training (PCT), an exercise program, can improve fitness and reduce heart disease, diabetes, and obesity risks compared to standard care (Attention Control) in participants.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of physical activity intervention, typical concerns might include muscle soreness or strain. The trial will monitor for any adverse reactions related to increased physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use effective birth control or abstain from sex for six months during the study.
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I am a woman with newly diagnosed Stage I-III breast cancer.
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I am over 18 years old.
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My breast cancer is in remission with no signs of disease.
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I have had surgery to remove a breast lump or the entire breast.
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I do not have chronic diseases like uncontrolled diabetes, high blood pressure, or thyroid issues.
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I can start an exercise program without heart, lung, or joint issues stopping me.
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I am obese with a BMI over 30, body fat over 30%, and waist size over 35 inches.
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I have not lost more than 10% of my weight in the last 6 months.
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I do not plan to have reconstructive surgery with flap repair during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Insulin Resistance
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -Visceral adiposity
Change in Metabolic Dysregulation (MetD) After Completion of Phase 1 Progressive Combine Training (PCT) -metabolic syndrome (MSY)
Secondary outcome measures
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - Visceral adiposity
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups - metabolic syndrome (MSY)
Compare Metabolic Dysregulation (MetD) in Progressive Combine Training (PCT) and Attention (AC) groups -Insulin Resistance
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Progressive combine training (PCT)Experimental Treatment1 Intervention
Participants will be randomly assigned to Progressive combine training (PCT) group.
Participants will have two (2) baseline tests, then begin a two phase PCT program.
Phase 1: Supervised 16-week resistance and cardiovascular exercise at a local YMCA (months 1-4) or remotely at home via Zoom
Participants will receive midpoint testing, approximately week 8.
Phase 2: Unsupervised 16-week resistance and cardiovascular exercise at a local YMCA (months 5-8) or remotely at home
Participants will receive midpoint testing, approximately two months into phase 2.
After the two (2) 16-week phases, participants will be followed for 4 months.
Group II: Attention Control (AC)Active Control1 Intervention
Participants will be randomly assigned to Attention Control (AC) group.
Two (2) baseline tests will be performed prior to starting the program. Participants will perform 12 months of home-based stretching and have a 1x test performed during months 2, 4, 6, 8 and 10. Two (2) tests will be performed in month 12.
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Who is running the clinical trial?
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,295 Total Patients Enrolled
32 Trials studying Breast Cancer
8,724 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,821 Total Patients Enrolled
141 Trials studying Breast Cancer
22,457 Patients Enrolled for Breast Cancer
Christina Dieli-Conwright, PhD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
195 Total Patients Enrolled
1 Trials studying Breast Cancer
135 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't finished any surgery, chemotherapy, or radiation for my diagnosis.You consider yourself as Latina.I agree to use effective birth control or abstain from sex for six months during the study.I am a woman with newly diagnosed Stage I-III breast cancer.I cannot travel to the specified hospital or exercise facility for data collection.I am on hormone therapy for cancer and will continue it during the study.I am over 18 years old.My breast cancer is in remission with no signs of disease.I do not have any uncontrolled illnesses or infections, and if I'm a woman with diabetes, I'm not using Metformin.You currently do less than 60 minutes of planned exercise each week.My cancer has spread to other parts of my body.I have had surgery to remove a breast lump or the entire breast.I speak English or Spanish.I plan to have reconstructive surgery with flap repair during the study.You are not considered centrally obese based on the definition provided.I do not have chronic diseases like uncontrolled diabetes, high blood pressure, or thyroid issues.You are currently a smoker.I am not currently on any experimental treatments or undergoing chemotherapy or radiation.I don't have any muscle, heart, lung, or nerve conditions that stop me from exercising.You do more than 60 minutes of planned exercise each week.I finished my initial cancer treatment within the last year.I can start an exercise program without heart, lung, or joint issues stopping me.I do not have any other active cancers.I am obese with a BMI over 30, body fat over 30%, and waist size over 35 inches.I have not lost more than 10% of my weight in the last 6 months.You have lost more than 10% of your body weight in the last 6 months.I do not plan to have reconstructive surgery with flap repair during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Progressive combine training (PCT)
- Group 2: Attention Control (AC)
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.
Does this research protocol have an ongoing recruitment phase?
"According to information available on clinicaltrials.gov, this medical research is presently recruiting volunteers and has been listed since August 12th 2021 with its most recent edit made on September 12th 2022."
Answered by AI
What is the current enrollment of this research project?
"Affirmative. According to the records available on clinicaltrials.gov, this research endeavor is presently seeking out participants and was initially posted on August 12th 2021. The trial requires 160 individuals from a single medical centre for completion."
Answered by AI
What outcomes is this research endeavor striving to attain?
"This trial, which is slated to last 16 weeks, seeks to measure changes in Metabolic Dysregulation (MetD) due specifically to Progressive Combine Training (PCT). Other objectives include gauging Visceral adiposity by dual-energy X-ray absorptiometry (DXA), waist to hip ratio (WHR) and bioelectrical impedance technology(BIA), assessing insulin resistance status with Homeostasis Model Assessment (HOMA), and determining the frequency of metabolic syndrome diagnosis via American Heart Association's criteria."
Answered by AI
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