Dietary/Physical Activity intervention for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast CancerDietary/Physical Activity intervention - Behavioral
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial will compare the effects of a diet and exercise intervention against usual care on breast cancer patients undergoing chemotherapy.

Treatment Effectiveness

Study Objectives

3 Primary · 14 Secondary · Reporting Duration: two years post-diagnosis

12 months after enrollment
Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs)
24 months after enrollment
Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs).
At the time of surgical resection following initial course of chemotherapy
Pathological complete response
Baseline (pre-chemotherapy)
fecal microbiome
Month 7
Body composition-body mass index (BMI)
Month 7
Adherence to Treatment measured by chemotherapy completion rate
one year post-diagnosis
Body composition-bone mineral density.
Body composition-lean body mass
two years post-diagnosis
Body composition-BMI
Body composition-body fat
Body composition-body weight
Body composition-bone mineral density
Body composition-lean bone mass
C-reactive protein level
Fecal microbiome
Insulin level
Quality of Life

Trial Safety

Trial Design

2 Treatment Groups

Usual Care Group
1 of 2
Dietary/Physical Activity Intervention
1 of 2

Active Control

Experimental Treatment

173 Total Participants · 2 Treatment Groups

Primary Treatment: Dietary/Physical Activity intervention · No Placebo Group · N/A

Dietary/Physical Activity Intervention
Behavioral
Experimental Group · 1 Intervention: Dietary/Physical Activity intervention · Intervention Types: Behavioral
Usual Care Group
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: two years post-diagnosis

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,679 Previous Clinical Trials
21,087,866 Total Patients Enrolled
25 Trials studying Breast Cancer
3,147 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,338 Total Patients Enrolled
926 Trials studying Breast Cancer
1,536,366 Patients Enrolled for Breast Cancer
Melinda Irwin, Ph.D.Principal InvestigatorYale University
Tara Sanft, M.D.Principal InvestigatorYale University

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of breast cancer.
You are scheduled to receive chemotherapy.
You are able to read and understand the instructions in English.