Clinical trial · Interventional
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
NCT03314688CI-TRIAL-00118457completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary/Physical Activity intervention | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care Group
- description
- 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.
- interventionNames
- Behavioral: Usual Care
- type
- EXPERIMENTAL
- label
- Dietary/Physical Activity Intervention
- description
- 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).
- interventionNames
- Behavioral: Dietary/Physical Activity intervention
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDPuklin 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
- DERIVEDSanft 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
- DERIVEDSanft 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