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Exercise for Breast Cancer
N/A
Recruiting
Led By Christina M Dieli-Conwright, PhD
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
Have undergone a lumpectomy or mastectomy
Is in breast cancer remission with no detectable disease present
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study Summary
This trial will test whether exercising can help breast cancer patients by decreasing inflammation in their fat tissue.
Who is the study for?
This trial is for women over 18 with breast cancer who've finished treatment, are in remission, and meet specific health criteria like a BMI >30. They must not have other uncontrolled illnesses or be on certain treatments. Participants should exercise less than 60 minutes per week and agree to use contraception.Check my eligibility
What is being tested?
The study tests if a 16-week exercise program can reduce inflammation in fat tissue of breast cancer survivors. It involves TARE (Targeted Radiotherapy), Home-Based Stretching, and CARE (Comprehensive Assessment and Response Evaluation).See study design
What are the potential side effects?
While the trial focuses on exercise, potential side effects may include typical risks associated with physical activity such as muscle soreness, fatigue, or injury especially if participants have pre-existing conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery to remove a breast lump or the entire breast.
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My breast cancer is in remission with no signs of disease.
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I do not plan to have reconstructive surgery with flap repair during the trial.
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I do not have chronic diseases like uncontrolled diabetes, high blood pressure, or thyroid issues.
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I have not lost 10% or more of my weight in the last 6 months.
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I can start a supervised exercise program without health issues stopping me.
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I have breast cancer that is not stage IV, is low grade, and positive for estrogen and progesterone.
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I am over 18 years old.
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I am considered centrally obese with a BMI over 30, body fat over 30%, and waist size over 35 inches.
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I agree to use effective birth control or abstain from sex for six months during the study.
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
Decrease in adipose tissue levels of inflammation.
Secondary outcome measures
Interventional procedure
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Traditional Aerobic Resistance Exercise (TARE)Experimental Treatment1 Intervention
This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months
- 16 weeks of traditional aerobic and resistance exercise
Group II: Circuit-style aerobic and resistance Exercise(CARE)Experimental Treatment1 Intervention
This research study involves exercise. Participants in this study will be assigned to one of 2 exercise groups, undergo three (voluntary) biopsies of fat tissue, and participate in 7 testing visits and 48 exercise training visits. Participation is expected to last 12 months.
-16 weeks of circuit-style aerobic and resistance exercise
Group III: Home-Based StretchingActive Control1 Intervention
Attention Control for 16 weeks home-based stretching
-structured home-based stretching program, participants will be asked to maintain their current activity level for the 4-month study duration, and will be offered the CARE program upon study completion
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,680 Total Patients Enrolled
141 Trials studying Breast Cancer
22,317 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,832 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,060 Patients Enrolled for Breast Cancer
Christina M Dieli-Conwright, PhDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to remove a breast lump or the entire breast.I do not have chronic diseases like uncontrolled diabetes, high blood pressure, or thyroid issues.You are currently a smoker.My breast cancer is in remission with no signs of disease.I do not plan to have reconstructive surgery with flap repair during the trial.I am not currently on any experimental treatments or other cancer therapies.You have not smoked or used any tobacco products in the past year.I have not lost 10% or more of my weight in the last 6 months.I can start a supervised exercise program without health issues stopping me.I have breast cancer that is not stage IV, is low grade, and positive for estrogen and progesterone.I will take a pregnancy test using a urine strip before my DEXA scan.I am on, or willing to stay on, hormone therapy or specific antibody treatments for the study duration.I am over 18 years old.You do not have excessive fat around your waist.You do more than 60 minutes of organized exercise every week.I do not have any other active cancers.I do not have any uncontrolled illnesses like infections or diabetes.I plan to have reconstructive surgery with flap repair during the trial.My cancer has spread to other parts of my body.I am considered centrally obese with a BMI over 30, body fat over 30%, and waist size over 35 inches.I do not have any muscle, heart, lung, or nerve conditions that prevent me from exercising.I agree to use effective birth control or abstain from sex for six months during the study.I have completed any initial or additional cancer treatments given.You currently do less than 60 minutes of structured exercise each week.I cannot travel to the exercise facilities.I haven't finished any surgery, chemotherapy, or radiation for my diagnosis.
Research Study Groups:
This trial has the following groups:- Group 1: Home-Based Stretching
- Group 2: Traditional Aerobic Resistance Exercise (TARE)
- Group 3: Circuit-style aerobic and resistance Exercise(CARE)
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 individuals are involved in this research effort?
"Affirmative. The data found on clinicaltrials.gov states that this trial is actively seeking participants, first posted on August 13th 2021 and recently revised on January 12th 2022. 300 patients must be recruited from 2 separate sites in order to move forward with the study."
Answered by AI
Are there any vacancies available in this medical experiment?
"Right. The information posted on clinicaltrials.gov confirms that this trial, which was originally listed on August 13th 2021, is currently accepting enrolments. Up to 300 patients will be admitted between two medical centres."
Answered by AI
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