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: Active, not recruiting
• 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
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 2-year 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.
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.

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.	before initiating chemotherapy to post-chemotherapy, up to 7 months
Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs)	Assessed by urinary aromatase inhibitor levels.	12 months after enrollment
Adherence to endocrine therapy in women taking tamoxifen or aromatase inhibitors (AIs).	Assessed by urinary aromatase inhibitor levels.	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.	At the time of surgical resection following initial course of chemotherapy
Insulin level	Assessed by fasting blood (fast of 12 hours or more).	Baseline (pre-chemotherapy)
Insulin level	Assessed by fasting blood (fast of 12 hours or more).	Up to 7 months from treatment onset
Insulin level	Assessed by fasting blood (fast of 12 hours or more).	one year post-diagnosis
Insulin level	Assessed by fasting blood (fast of 12 hours or more).	two years post-diagnosis
C-reactive protein level	Assessed by fasting blood (fast of 12 hours or more).	Baseline (pre-chemotherapy)
C-reactive protein level	Assessed by fasting blood (fast of 12 hours or more).	Up to 7 months from treatment onset
C-reactive protein level	Assessed by fasting blood (fast of 12 hours or more).	one year post-diagnosis
C-reactive protein level	Assessed by fasting blood (fast of 12 hours or more).	two years post-diagnosis
Body composition-body weight	Assessed by measured weight	Baseline (pre-chemotherapy)
Body composition-body mass index (BMI)	Assessed from measured weight and measured height	Baseline (pre-chemotherapy)
Body composition-body fat	Assessed by dual energy X-ray absorptiometry (DEXA)	Baseline (pre-chemotherapy)
Body composition-lean body mass	Assessed by dual energy X-ray absorptiometry (DEXA)	Baseline (pre-chemotherapy)
Body composition-bone mineral density	Assessed by dual energy X-ray absorptiometry (DEXA)	Baseline (pre-chemotherapy)
Body composition-body weight	Assessed by measured weight	Up to 7 months from treatment onset
Body composition-body mass index (BMI)	Assessed from measured weight and measured height	Up to 7 months from treatment onset
Body composition-body fat	Assessed by dual energy X-ray absorptiometry (DEXA)	Up to 7 months from treatment onset
Body composition-lean body mass	Assessed by dual energy X-ray absorptiometry (DEXA)	Up to 7 months from treatment onset
Body composition-bone mineral density	Assessed by dual energy X-ray absorptiometry (DEXA)	Up to 7 months from treatment onset
Body composition-body weight	Assessed by measured weight	one year post-diagnosis
Body composition-BMI	Assessed from measured weight and measured height	one year post-diagnosis
Body composition-body fat	Assessed by dual energy X-ray absorptiometry (DEXA)	one year post-diagnosis
Body composition-lean body mass	Assessed by dual energy X-ray absorptiometry (DEXA)	one year post-diagnosis
Body composition-bone mineral density.	Assessed by dual energy X-ray absorptiometry (DEXA)	one year post-diagnosis
Body composition-body weight	Assessed by measured weight	two years post-diagnosis
Body composition-BMI	Assessed from measured weight and measured height	two years post-diagnosis
Body composition-body fat	Assessed by dual energy X-ray absorptiometry (DEXA)	two years post-diagnosis
Body composition-lean bone mass	Assessed by dual energy X-ray absorptiometry (DEXA)	two years post-diagnosis
Body composition-bone mineral density	Assessed by dual energy X-ray absorptiometry (DEXA)	two years post-diagnosis
Quality of Life	Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.	Baseline (pre-chemotherapy)
Quality of Life	Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.	Up to 7 months from treatment onset
Quality of Life	Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.	one year post-diagnosis
Quality of Life	Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire.	two years post-diagnosis
fecal microbiome	Assessed by stool collection.	Baseline (pre-chemotherapy)
Fecal microbiome	Assessed by stool collection.	Up to 7 months from treatment onset
Fecal microbiome	Assessed by stool collection.	one year post-diagnosis
Fecal microbiome	Assessed by stool collection.	two years post-diagnosis
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; Principal Investigator: Tara Sanft, M.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.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): March 24, 2023
• Study Completion (Estimated): July 31, 2026

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 (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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