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Diet and Exercise Intervention for Breast Cancer
N/A
Waitlist Available
Led By Melinda Irwin, Ph.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled to receive neoadjuvant or adjuvant chemotherapy
Agrees to be randomly assigned to either intervention or usual care group
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years post-diagnosis
Awards & highlights
Study Summary
This trial will compare the effects of a diet and exercise intervention against usual care on breast cancer patients undergoing chemotherapy.
Who is the study for?
This trial is for English-speaking women recently diagnosed with Stage I-III breast cancer who are about to start chemotherapy. They must be able to walk and follow the study's guidelines. Women can't join if they're pregnant, planning pregnancy, have had a stroke or heart failure in the past year, already follow similar health guidelines, or have completed their second chemo session.Check my eligibility
What is being tested?
The study compares two approaches: one group will receive guidance on diet and exercise after their diagnosis (intervention), while the other will continue with their usual care without additional advice (control). The goal is to see how these strategies affect treatment adherence, body composition, and biomarkers.See study design
What are the potential side effects?
Since this trial focuses on lifestyle changes rather than medication, side effects may include typical exercise-related issues like muscle soreness or fatigue. Dietary changes might cause digestive adjustments but aren't expected to cause severe side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for chemotherapy before or after surgery.
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I agree to be randomly placed in a treatment or standard care group.
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I have been diagnosed with early to locally advanced breast cancer.
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I can walk on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ five years post-diagnosis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years post-diagnosis
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to Treatment measured by chemotherapy completion rate
Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs)
Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs).
Secondary outcome measures
Body composition-BMI
Body composition-body fat
Body composition-body mass index (BMI)
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dietary/Physical Activity InterventionExperimental Treatment1 Intervention
Eleven 30-min counseling sessions over six months (weekly, then biweekly, then monthly) with additional sessions in the latter 6 months (5 additional monthly sessions for a total of 16 sessions), timed with their oncology visit or via telephone if not coming in for oncology visit. Sessions focus on motivating health dietary choices and physical activity (home-based program).
Group II: Usual Care GroupActive Control1 Intervention
Standardized breast cancer follow up care and materials regarding treatment (i.e., chemotherapy and endocrine therapy when relevant).
Lifestyle intervention books for breast cancer survivors at the end of the 2-year study. Women will also be offered a counselling session with a registered study dietician at the end of the study.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,240 Total Patients Enrolled
27 Trials studying Breast Cancer
3,235 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,473 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Melinda Irwin, Ph.D.Principal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I follow recommended diet and exercise guidelines.I have not had a stroke, heart attack, or severe heart failure in the past year.I am scheduled for chemotherapy before or after surgery.I have been diagnosed with dementia or a major psychiatric condition.I have finished my second round of chemotherapy.I agree to be randomly placed in a treatment or standard care group.I have been diagnosed with early to locally advanced breast cancer.I can walk on my own.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Group
- Group 2: Dietary/Physical Activity Intervention
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 recruitment efforts still underway for this experiment?
"Clinicaltrials.gov evidences that this trial, initially announced on the 2nd of January 2018, is no longer actively recruiting participants. Fortunately, there are still hundreds more clinical trials seeking enrolment at present."
Answered by AI
What are the primary aims of this research initiative?
"This trial aims to evaluate the adherence of women that are taking tamoxifen or aromatase inhibitors up until 7 months post-chemotherapy. Secondary goals include measuring pathological complete response, fecal microbiome and body composition -body mass index (BMI)."
Answered by AI
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