Stay on Track: A Pilot Study of the Effects of Exercise on Mitigating Side Effects and Altering Inflammatory Biomarker Profiles During Radiation Therapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm
研究概览
简要总结
The purpose of this study is to examine the impact of a lifestyle intervention. The study will examine the Stay on Track program, dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy.
详细描述
Research Design. The investigators will be conducting an randomized trial in 60 women undergoing radiation treatment for breast cancer to examine the feasibility of a 12-week lifestyle intervention that addresses diet and physical activity and to explore the impact on behavioral, biological and psychosocial outcomes.
Procedure Summary. Patients who are eligible are consented by the research coordinator, after which a baseline assessment will be scheduled. The baseline assessment requires 60 minutes and includes questionnaires, height/weight, dual energy x-ray absorptiometry (DEXA), and phlebotomy. Participants will also wear the Fitbit for one week to establish baseline activity level. After the baseline assessment, women are then randomly assigned to: the 12-week "Stay on Track" lifestyle intervention or the 12-week self-guided control. Both groups complete a post-intervention and a 3-month follow-up visit identical to their baseline assessment. Self-guided controls can utilize their Fitbit and will receive informative binders 24 weeks' post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •> 18 years of age;
- •confirmed primary non-metastatic breast adenocarcinoma;
- •planned lumpectomy/segmentectomy/partial mastectomy surgery for primary breast cancer;
- •planning to undergo adjuvant whole breast radiation therapy following a lumpectomy;
- •Have a Karnovsky Performance Score of 70 or above (see Appendix)
- •Patient's Body Mass Index (BMI) is greater than determine by the treating physician, not currently meeting physical activity guidelines: moderate physical activity for at least 30 minutes at least five days a week AND 2 weekly sessions of resistance exercise;
- •have access to a mobile phone with capacity for text messaging (either unlimited or aware and accepting of text messaging charges);
- •understand and speak English;
- •physically able to engage in the intervention;
- •accepting of randomization (Note that anti-estrogen therapy is allowed.)
排除标准
- •Patients who have metastatic disease;
- •Patients with a history of prior malignancy within the past 3 years, other than non-melanoma skin cancer.
- •Patients with serious orthopedic, cardiovascular, or pulmonary conditions, have serious psychiatric or cognitive problems.
- •Patients who have received chemotherapy for their breast cancer.
- •Patients with prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
研究组 & 干预措施
12-week "Stay on Track" intervention
The study intervention includes three personal exercise training sessions, three dietary counseling sessions, use of a physical activity tracking device, and approximately three weekly text messaging
干预措施: Lifestyle- Supportive Care (Behavioral)
12-week self-guided control
The self guided group does not receive the study intervention, but is offered a Nutrition and wellness guide at the end of 6 months
干预措施: Lifestyle- Supportive Care (Behavioral)
结局指标
主要结局
Percent time of personal fitness tracker use during the intervention period for the Stay on Track intervention arm
时间窗: 6 months
次要结局
- Measures of skin side effects (CTCAE v4.0 Scoring)(6 months)
- Quality of life (FACT-B Questionnaire) over the study period associated with intervention and activity(6 months)
- Changes in biomarker (IL-6) associated with intervention and activity(6 months)
- Dietary intake (assessed via Full Length Block Questionnaire)(6 months)
- The percent of eligible patient who choose to take part in the study(6 months)
- Changes in biomarker (IL-8) associated with intervention and activity(6 months)
- Number of personal exercise sessions were attended by members in the Stay on Track Intervention Arm(6 months)
- Changes in lean soft tissue over the study period associated with intervention and activity(6 months)
- Changes in BMI (weight and height will be combined to report BMI in kg/m^2) over the study period associated with intervention and activity(6 months)
- Measures of fatigue (Piper Fatigue Scale Score and physician CTCAE v4.0 Scoring)(6 months)
- Changes in biomarker (GM-CSF) associated with intervention and activity(6 months)
- Changes in biomarker (IL-1beta) associated with intervention and activity(6 months)
- Percent of participant retention thoughout the 12-week intervention through the six month follow-up(6 months)
- Measures of physical activity (self-report and objective)(6 months)
- Changes in biomarker (IL-1alpha) associated with intervention and activity(6 months)
- Changes in biomarker (MCP-1) associated with intervention and activity(6 months)
- Measures of pain (PROMIS Scale v1.0- Pain Intensity 3a Questionnaire) over the study period associated with intervention and activity(6 months)
- Changes in biomarker (IFN-gamma) associated with intervention and activity(6 months)
- Changes in biomarker (CRP) associated with intervention and activity(6 months)
- Changes in blood insulin level associated with intervention and activity(6 months)
- Changes in biomarker (IL-4) associated with intervention and activity(6 months)
- Changes in biomarker (adiponectin) associated with intervention and activity(6 months)
- Changes in biomarker (IL-10) associated with intervention and activity(6 months)
- Changes in biomarker (IL-12) associated with intervention and activity(6 months)
- Changes in biomarker (TNF-alpha) associated with intervention and activity(6 months)
- Changes in biomarker (leptin) associated with intervention and activity(6 months)
- Changes in blood hemoglobin A1C level associated with intervention and activity(6 months)
- Changes in blood glucose level associated with intervention and activity(6 months)
研究者
John Longo
Assistant Professor Radiation Oncology
Medical College of Wisconsin