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Lifestyle Interventions for Breast Cancer
N/A
Waitlist Available
Led By Lorenzo Cohen
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must be oriented to person, place, and time
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether an integrative oncology program can improve cancer-related outcomes in patients with stage II or III breast cancer undergoing radiation therapy.
Who is the study for?
This trial is for English-speaking women with stage II or III breast cancer who are about to start a 4-6 week course of radiotherapy. They should be oriented and have a BMI of at least 24.45. Participants must also have poor lifestyle habits, like eating less than three servings of fruits and vegetables per day, exercising minimally, and rarely engaging in mind-body practices.Check my eligibility
What is being tested?
The study tests an integrative oncology program that includes diet changes, exercise, stress management, social support, and reducing environmental toxins during radiation therapy to see if it improves biological processes related to cancer and enhances patients' quality of life.See study design
What are the potential side effects?
Since the interventions involve lifestyle modifications rather than medications, typical drug side effects aren't expected. However, participants may experience discomfort from increased physical activity or dietary changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am aware of who I am, where I am, and the current time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in biological pathways
Changes in dietary patterns
Changes in fitness levels
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (IO interventions)Experimental Treatment8 Interventions
Patients undergo up to 7 different IO intervention sessions per week during their 6-week course of radiotherapy for between 1 and 3 hours each session, in addition to, up to 6 aerobic training sessions per week and one grocery store trip during the course of the program. IO intervention programs consist of nutritional coaching, behavioral therapy, yoga and meditation practice, resistance training, and a weekly meal sharing and cooking class. Patients then have weekly meetings with the study psychologist on the computer for 6 months, followed by a monthly meeting on the computer from 6-12 months, and 2 hour meetings at all follow-up appointments during the first year after radiotherapy.
Group II: Arm II (standard of care)Active Control4 Interventions
Patients undergo standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,043 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,671 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Lorenzo CohenPrincipal InvestigatorM.D. Anderson Cancer Center
11 Previous Clinical Trials
58,184 Total Patients Enrolled
1 Trials studying Breast Cancer
452 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had another primary cancer diagnosis in the last 5 years, except for non-melanoma skin cancers.I am a woman with stage II or III breast cancer scheduled for 4-6 weeks of radiotherapy.My diabetes is not well-managed according to my doctor.You need to have a BMI of 24.45 or higher, which is a measure of your weight in relation to your height.I have difficulty hearing or communicating.My breast cancer has come back after treatment.You have been diagnosed with major mental health conditions like schizophrenia, bipolar disorder, or dementia.I am aware of who I am, where I am, and the current time.I cannot move in and out of a chair without help.You need to meet at least two of the following lifestyle criteria: 1) eat less than 3 servings of fruits and vegetables per day; 2) do less than 75 minutes of moderate or vigorous activity per week (like brisk walking or biking); and 3) practice mind-body activities less than 4 times a month.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (standard of care)
- Group 2: Arm I (IO interventions)
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.
Are there any slots available in this medical research to participate?
"The latest update to the clinicaltrials.gov listing for this medical trial indicates that it is not actively recruiting patients as of October 6th 2022. This study was initially posted on June 13th 2013, however, there are 2289 other trials presently seeking participants."
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