Clinical trial NCT03314688: Lifestyle, Exercise, and Nutrition Study Early After Diagnosis
Official title: Lifestyle, Exercise, and Nutrition Study Early After Diagnosis (LEANer)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-10-19
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to Treatment Measured by Chemotherapy Completion Rate
timeFrame: before initiating chemotherapy to post-chemotherapy, up to 7 months
measure: Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs)
timeFrame: 12 months after enrollment
measure: Adherence to Endocrine Therapy in Women Taking Tamoxifen or Aromatase Inhibitors (AIs).
timeFrame: 24 months after enrollment
Secondary outcomes:
measure: Pathological Complete Response
timeFrame: At the time of surgical resection following initial course of chemotherapy
measure: Insulin Level
timeFrame: Baseline (pre-chemotherapy)
measure: Insulin Level
timeFrame: Up to 7 months from treatment onset
measure: Insulin Level
timeFrame: one year post-diagnosis
measure: Insulin Level
timeFrame: two years post-diagnosis
measure: C-reactive Protein Level
timeFrame: Baseline (pre-chemotherapy)
measure: C-reactive Protein Level
timeFrame: Up to 7 months from treatment onset
measure: C-reactive Protein Level
timeFrame: one year post-diagnosis
measure: C-reactive Protein Level
timeFrame: two years post-diagnosis
measure: Body Composition-body Weight
timeFrame: Baseline (pre-chemotherapy)
measure: Body Composition-body Mass Index (BMI)
timeFrame: Baseline (pre-chemotherapy)
measure: Body Composition-body Fat
timeFrame: Baseline (pre-chemotherapy)
measure: Body Composition-lean Body Mass
timeFrame: Baseline (pre-chemotherapy)
measure: Body Composition-bone Mineral Density
timeFrame: Baseline (pre-chemotherapy)
measure: Body Composition-body Weight
timeFrame: Up to 7 months from treatment onset
measure: Body Composition-body Mass Index (BMI)
timeFrame: Up to 7 months from treatment onset
measure: Body Composition-body Fat
timeFrame: Up to 7 months from treatment onset
measure: Body Composition-lean Body Mass
timeFrame: Up to 7 months from treatment onset
measure: Body Composition-bone Mineral Density
timeFrame: Up to 7 months from treatment onset
measure: Body Composition-body Weight
timeFrame: one year post-diagnosis
measure: Body Composition-BMI
timeFrame: one year post-diagnosis
measure: Body Composition-body Fat
timeFrame: one year post-diagnosis
measure: Body Composition-lean Body Mass
timeFrame: one year post-diagnosis
measure: Body Composition-bone Mineral Density.
timeFrame: one year post-diagnosis
measure: Body Composition-body Weight
timeFrame: two years post-diagnosis
measure: Body Composition-BMI
timeFrame: two years post-diagnosis
measure: Body Composition-body Fat
timeFrame: two years post-diagnosis
measure: Body Composition-lean Bone Mass
timeFrame: two years post-diagnosis
measure: Body Composition-bone Mineral Density
timeFrame: two years post-diagnosis
measure: Quality of Life
timeFrame: Baseline (pre-chemotherapy)
measure: Quality of Life
timeFrame: Up to 7 months from treatment onset
measure: Quality of Life
timeFrame: one year post-diagnosis
measure: Quality of Life
timeFrame: two years post-diagnosis
measure: Fecal Microbiome
timeFrame: Baseline (pre-chemotherapy)
measure: Fecal Microbiome
timeFrame: Up to 7 months from treatment onset
measure: Fecal Microbiome
timeFrame: one year post-diagnosis
measure: Fecal Microbiome
timeFrame: two years post-diagnosis
measure: Healthy Eating Index
timeFrame: five years post-diagnosis
measure: Minutes Per Week of Moderate/Vigorous Physical Activity
timeFrame: five years post-diagnosis
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Dana Farber Cancer Center
state: Massachusetts
Study officials:
affiliation: Yale University
name: Melinda Irwin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Tara Sanft, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.