Lifestyle, Exercise, and Nutrition Study Early after Diagnosis (LEANer)

Protocol # :
Breast Neoplasms
Not Applicable
Disease Sites
Principal Investigator
Ligibel, Jennifer, A

Trial Description

The proposed study is a randomized trial evaluating the impact of a dietary and physical
activity guidelines intervention vs. usual care on adherence to breast cancer treatments,
body composition, and changes in biomarkers in 172 women newly diagnosed with breast cancer
scheduled to receive neoadjuvant or adjuvant chemotherapy.

Eligibility Requirements

Inclusion Criteria:

- Diagnosed with Stage I-III breast cancer

- Scheduled to receive neoadjuvant or adjuvant chemotherapy

- Physically able to walk

- Able to complete forms, understand instructions and read intervention book in English

- Agrees to be randomly assigned to either intervention or usual care group

Exclusion Criteria:

- Women who have completed their 2nd chemotherapy

- Women already practicing dietary or physical activity guidelines

- Are pregnant or intending to become pregnant in the next year

- Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection
fraction < 40%

- Presence of dementia or major psychiatric disease

- Non-English speaking