Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR)
研究概览
简要总结
The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.
详细描述
Women with stage II-III triple-negative breast cancer (TNBC) undergoing neoadjuvant chemo-immunotherapy will be enrolled in the study. Following screening, consent, and baseline assessment, participants will be randomized to either the intervention group (nutrition and exercise counseling) or the usual care group. Participants randomized to the intervention group will complete weekly remote sessions with the interventionist throughout the duration of chemotherapy. Each counseling session will last about 30 minutes and will be conducted remotely. The exercise regimen is home-based.
Study activities include completing surveys and attending two in-person study visits, each of which will include a blood draw, a 6-minute walk test to assess aerobic capacity and endurance, and a Dual Energy X-Ray Absorptiometry (DXA) scan to measure body composition.
The primary outcome is the pathologic complete response.
Researchers will also compare the exercise and nutrition program to usual care to determine if the program improves residual cancer burden, symptoms related to cancer treatment, body composition, and blood biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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 will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18 years or older.
- •Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC).
- •Be scheduled to receive neoadjuvant chemo-immunotherapy.
- •Be physically able to walk.
- •Be able to complete forms, understand instructions and read in English.
- •Agree to be randomly assigned to either group.
- •Have clearance from oncologist to participate.
- •Not exercising (less than 150 min/week).
- •Not consuming more than 7 fruits and vegetable/day.
排除标准
- •Having already started a 2nd chemotherapy cycle.
- •Pregnancy or intention to become pregnant.
- •Presence of dementia or major psychiatric disease.
- •Recent (past year) stroke, myocardial infarction, or congestive heart failure.
研究组 & 干预措施
Exercise and Medical Nutrition
Women randomized to the intervention will receive 10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. In weeks in which one of the 10 counseling sessions is not scheduled the interventionist will observe the participant in an exercise session via zoom, or check in with the participant by phone regarding their exercise. The intervention will continue until the day prior to the last chemotherapy infusion.
干预措施: Exercise and Medical Nutrition (Behavioral)
Usual care
Contact limited to study assessments.
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: Post breast cancer surgery, an average of 6 months
Pathologic Complete Response (pCR) is defined as having no invasive residual disease in the breast or regional lymph nodes after completing neoadjuvant chemotherapy (ypT0 ypN0 or ypT0/is ypN0)
Pathologic Complete Response (pCR)
时间窗: Post breast cancer surgery, an average of 6 months
Pathologic Complete Response (pCR) is defined as having no invasive residual disease in the breast or regional lymph nodes after completing neoadjuvant chemotherapy (ypT0 ypN0 or ypT0/is ypN0)
次要结局
- Residual Cancer Burden (RCB)(Post breast cancer surgery, an average of 6 months)
- Residual Cancer Burden (RCB)(Post breast cancer surgery, an average of 6 months)