Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging and Patient-reported Symptoms and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Compare the change in p16 from baseline to end of chemotherapy
研究概览
简要总结
Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy.
Participants: 200 patients age 21 or older with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy.
Procedures: The study entails screening, recruiting and consenting 200 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.
详细描述
The overall focus of this study remains the investigation of associations between p16 and assessments (independent and patient-reported) of chemotherapy-related toxicity (adverse events and symptoms) and patient-reported measures of function and quality of life. The research team has determined that p16 increases dramatically during chemotherapy and that p16 levels among persons of similar age are lower among those who exercise as compared to those who are sedentary. The research team hypothesizes that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, the study proposes to build on a completed trial, LCCC1334, and enroll 200 evaluable patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in an intervention that entails both aerobic and resistance exercises.
Results from both LCCC1334 and LCCC1410 and the proposed study, LCCC1749, will be used to provide evidence for a future grant application to conduct a randomized controlled trial in a larger study population to (1) establish the effect of physical activity on p16 levels during chemotherapy and (2) further evaluate how baseline and post-chemotherapy p16 levels correlate with measures of treatment-related toxicity and patient-reported outcomes over time. Findings from this study will also provide preliminary evidence for further investigations of the potential benefits of exercise during early breast cancer chemotherapy for (1) reducing the incidence and severity of peripheral neuropathy and (2) managing the interface of fatigue and perceived cognition deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study subjects must meet all of the inclusion criteria listed below to participate in this study:
- •21 years of age or older, female
- •Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
- •Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
- •English speaking
- •IRB approved, signed written informed consent
- •Approval from their treating physician to engage in moderate-intensity physical activity
- •Patient-assessed ability to walk and engage in moderate physical activity
- •Willing and able to meet all study requirements.
排除标准
- •All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria are:
- •One or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
- •Unable to walk or engage in moderate-intensity physical activity.
结局指标
主要结局
Compare the change in p16 from baseline to end of chemotherapy
时间窗: Baseline, 6-months post Baseline, 12-months post-Baseline
Compare the change in p16 from baseline to end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention.
次要结局
- Measure association of physical activity levels (Fitbit steps and strength training) with change in p16 levels(Baseline, during Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks) , and 12-months post-Baseline)
- Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the FACT/GOG-NTX(Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in functional status with the Karnofsky Performance Status(Baseline, 6-months post-Baseline)
- Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the PRO-CTCAE.(Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in QOL measures as assessed by the FACIT-F(Baseline, 6-months post-Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in QOL measures as assessed by the PROMIS Social Isolation Questionnaire.(Baseline, 6-months post-Baseline, 12-months post-Baseline)
- Measure associations between weight, physical activity and diet during chemotherapy.(Baseline, 3-months post-Baseline, 6-months post-Baseline, and 12-months post-Baseline)
- Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the CTCAE.(Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in QOL measures as assessed by the MHI-17(Baseline, 6-months post-Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in cognition by the PROMIS Cognitive Function-Short Form(Baseline, 6-months post-Baseline)
- Measure association of p16 with changes in cognition by the Blessed Memory Concentration test (BOMC)(Baseline, 6-months post-Baseline)
- Measure association of p16 with changes in functional status by the Medical Outcomes Survey.(Baseline, 6-months post-Baseline)
- Measure association of p16 with limitations in walking one block(Baseline, 6-months post-Baseline)
- Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the SPPB.(Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in QOL measures as assessed by the FACT-G(Baseline, 6-months post-Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in QOL measures as assessed by the MOS Social Activity Limitation Questionnaire(Baseline, 6-months post-Baseline, 12-months post Baseline)
- Measure association of p16 with changes in QOL measures as assessed by the PROMIS Instrumental Support(Baseline, 6-months post Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in QOL measures as assessed by the PROMIS Global Health(Baseline, 6-months post-Baseline, 12-months post-Baseline)
- Measure association of p16 with changes in functional status by the Timed Up and Go Test(Baseline, 6-months post-Baseline)
- Measure association of p16 with changes in functional status with the Instrumental Activities of Daily Living Survey(Baseline, 6-months post-Baseline)
- Measure association of p16 with number of Fall Questionnaire(Baseline, 6-months post-Baseline)