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
Effectiveness Progress
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
Safety Progress
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: BehavioralUsual Care Group
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: BehavioralTrial 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.
References
- Sanft, Tara, Maura Harrigan, Brenda Cartmel, Leah M. Ferrucci, Fang-Yong Li, Courtney McGowan, Michelle Zupa, et al.. 2021. “Effect of Healthy Diet and Exercise on Chemotherapy Completion Rate in Women with Breast Cancer: The Lifestyle, Exercise and Nutrition Early After Diagnosis (leaner) Study: Study Protocol for a Randomized Clinical Trial”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106508.
- 2018. "Lifestyle, Exercise, and Nutrition Study Early After Diagnosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03314688.
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Conditions
Cancer Related
Treatments