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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
Diagnosed with Stage I-III breast cancer
Scheduled to receive neoadjuvant or adjuvant chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years post-diagnosis
Awards & highlights
No Placebo-Only Group

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 below
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You have been diagnosed with early stage breast cancer.
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You are planning to have chemotherapy before or after surgery.
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You are able to walk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years post-diagnosis
This trial's timeline: 3 weeks for screening, Varies for treatment, and five years post-diagnosis for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,830 Previous Clinical Trials
2,726,980 Total Patients Enrolled
27 Trials studying Breast Cancer
3,235 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,574 Previous Clinical Trials
41,224,003 Total Patients Enrolled
937 Trials studying Breast Cancer
1,541,326 Patients Enrolled for Breast Cancer
Melinda Irwin, Ph.D.Principal InvestigatorYale University

Media Library

Dietary/Physical Activity intervention Clinical Trial Eligibility Overview. Trial Name: NCT03314688 — N/A
Breast Cancer Research Study Groups: Usual Care Group, Dietary/Physical Activity Intervention
Breast Cancer Clinical Trial 2023: Dietary/Physical Activity intervention Highlights & Side Effects. Trial Name: NCT03314688 — N/A
Dietary/Physical Activity intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03314688 — N/A

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
~24 spots leftby Feb 2025