Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Dietary/Physical Activity intervention

Detailed Description

Currently the Department of Health and Human Services, the American Cancer Society and others provide diet and exercise guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines, and also elect to delay concerted efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse changes in body composition and breast cancer biomarkers and may even improve the efficacy of treatment resulting in improved breast cancer prognosis. Further, by increasing our understanding of the mechanisms mediating the association between lifestyle behaviors and breast cancer survival, this study will improve our knowledge of how changes in diet and physical activity influence breast cancer outcomes. Lastly, guidelines for breast cancer survivors also overlap with those for diabetes and cardiovascular disease (CVD) prevention, the latter being a common cause of breast cancer mortality.

The proposed study will examine, in 172 women newly diagnosed with Stage I-III breast cancer who are not practicing the dietary and lifestyle guidelines, and who are scheduled to receive neoadjuvant or adjuvant chemotherapy, the effect of a 1-year dietary and physical activity guidelines intervention vs. usual care on the following breast cancer outcomes measured before beginning chemotherapy (Time 0), post chemotherapy (Time 1), at one-year post-diagnosis (Time 2), at two years post-diagnosis (Time 3), and at five-years post-diagnosis (Time 4): adherence to treatment, and changes in biomarkers, body composition, diet, physical activity and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary/Physical Activity 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).	Behavioral: Dietary/Physical Activity intervention; Motivational counseling to follow established dietary and exercise guidelines.
Active Comparator: Usual Care Group; 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.	Behavioral: Usual Care; Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Treatment Measured by Chemotherapy Completion Rate	Chemotherapy completion rate will be assessed (via medical records) as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. RDI is calculated by dividing the participant's actual dose by the planned dose to get a percentage of actual dose/planned dose.	before initiating chemotherapy to post-chemotherapy, up to 7 months
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)	This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence.; In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted); In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted); In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted)	12 months after enrollment
Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).	This outcome was updated when results were entered. COVID restrictions prevented the intended method of assessment using urine collection. In its place are the responses on 3 questions regarding adherence. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted- Q1) In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q2) In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted- Q3)	24 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response	In the subset of patients receiving neoadjuvant chemotherapy, no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Data presented here is the number of participants with a pathological Complete Response.	At the time of surgical resection following initial course of chemotherapy
Mean Insulin Level	Assessed by fasting blood (fast of 12 hours or more).	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean C-reactive Protein Level	Assessed by fasting blood (fast of 12 hours or more).	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year
Mean Body Composition-body Weight	Assessed by measured weight	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Mass Index (BMI)	Assessed from measured weight and measured height	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Body Composition-body Fat	Assessed by dual energy X-ray absorptiometry (DEXA)	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-lean Body Mass	Assessed by dual energy X-ray absorptiometry (DEXA)	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Body Composition-bone Mineral Density	Assessed by dual energy X-ray absorptiometry (DEXA), -1.0 or higher are normal; -1.1 to -2.4 indicate low bone mass (osteopenia), and -2.5 or lower indicate osteoporosis.	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health (GPH)	PROMIS Global Physical Health (GPH) score is a measure of physical well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80.	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Mean Score Quality of Life (QoL) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Mental Health (GMH)	PROMIS Global Mental Health (GMH) score is a measure of mental well-being. It uses a T-score metric standardized to a U.S. general population mean of 50 and a standard deviation of 10. Higher scores indicate better physical health, with scores typically ranging from 20 to 80.	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year, 2 years
Fecal Microbiome	Number of participants that were able to provide a sample.	Baseline (pre-chemotherapy), Up to 7 months from treatment onset (post chemo), 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy Eating Index	Assessed by food frequency questionnaire	five years post-diagnosis
Minutes Per Week of Moderate/Vigorous Physical Activity	Assessed by the modified physical activity questionnaire	five years post-diagnosis

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Melinda Irwin, Ph.D., Yale University

Publications and helpful links

General Publications

• Sanft T, Harrigan M, Cartmel B, Ferrucci LM, Li FY, McGowan C, Zupa M, Nguyen TH, Ligibel J, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones B, Knobf T, Chagpar A, Silber A, Irwin ML. 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. Contemp Clin Trials. 2021 Oct;109:106508. doi: 10.1016/j.cct.2021.106508. Epub 2021 Jul 16.
• Puklin LS, Li FY, Ferrucci LM, Cartmel B, Harrigan M, McGowan C, Zupa M, Ligibel JA, Sanft T, Irwin ML. Effect of a lifestyle intervention during chemotherapy for breast cancer on quality of life. JNCI Cancer Spectr. 2026 Jan 9;10(1):pkaf125. doi: 10.1093/jncics/pkaf125.
• Sanft T, Harrigan M, McGowan C, Cartmel B, Zupa M, Li FY, Ferrucci LM, Puklin L, Cao A, Nguyen TH, Neuhouser ML, Hershman DL, Basen-Engquist K, Jones BA, Knobf T, Chagpar AB, Silber A, Tanasijevic A, Ligibel JA, Irwin ML. Randomized Trial of Exercise and Nutrition on Chemotherapy Completion and Pathologic Complete Response in Women With Breast Cancer: The Lifestyle, Exercise, and Nutrition Early After Diagnosis Study. J Clin Oncol. 2023 Dec 1;41(34):5285-5295. doi: 10.1200/JCO.23.00871. Epub 2023 Sep 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet
• Other Study ID Numbers: 2000020335; 1R01CA207753-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No