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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years post-diagnosis

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years post-diagnosis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years post-diagnosis

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years post-diagnosis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)

Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).

Adherence to Treatment Measured by Chemotherapy Completion Rate

Secondary study objectives

Body Composition-BMI

Body Composition-body Fat

Body Composition-body Mass Index (BMI)

+12 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 study. Women will also be offered a counselling session with a registered study dietician at the end of the study.

Do I qualify?Apply below to find out