Lifestyle, Exercise, and Nutrition Study Early After Diagnosis

NCT03314688 | Active Not Recruiting Results

• 2 other identifiers: 20000203351R01CA207753-01A1
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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. 1. In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? ('All the time' responses counted) 2. In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? ('Never' responses counted) 3. 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 Outcomes (39)

• Pathological Complete Response

  At the time of surgical resection following initial course of chemotherapy

• Insulin Level

  Baseline (pre-chemotherapy)

• Insulin Level

  Up to 7 months from treatment onset

• Insulin Level

  one year post-diagnosis

• Insulin Level

  two years post-diagnosis

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

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

Dietary/Physical Activity Intervention

EXPERIMENTAL

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

Interventions

Dietary/Physical Activity intervention BEHAVIORAL

Motivational counseling to follow established dietary and exercise guidelines.

Dietary/Physical Activity Intervention

Usual Care BEHAVIORAL

Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Yale University

New Haven, Connecticut, 06510, United States

Location

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (3)

• 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.

  PMID: 41452765 DERIVED

• 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.

  PMID: 37656930 DERIVED

• 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.

  PMID: 34274495 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Tara Sanft, MD
• Organization: Yale School of Medicine

tara.sanft@yale.edu

(203) 200-2328

Study Officials

• Melinda Irwin, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Tara Sanft, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The following study personnel will be masked to participant study arm: the staff performing DXA scan and blood processing/biomarker evaluation. The staff performing clinic measures, study staff reviewing forms and entering data, the PI and Co-Is, the statistician, study manager, and interventionists (study dieticians) will be unblinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: October 19, 2017
• Study Start: January 2, 2018
• Primary Completion: March 24, 2023
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 3, 2025
• Results First Posted: May 14, 2024

Record last verified: 2025-01

Locations

US (2)