NCT03270111已完成不适用
High Energy Expenditure From Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
Carol Fabian, MD2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年9月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Adherence to supervised exercise sessions
研究概览
简要总结
The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction.
详细描述
All subjects participate in same intervention. Intervention consists of a 6-month structured weight loss program utilizing portion controlled meals and a prescribed level of graduated physical activity with an eventual goal of 200 minutes or more per week. The program will include twice weekly sessions with a trainer at a local YMCA, and weekly phone group sessions the first 3 months with transition to unsupervised exercise and less frequent group phone sessions the second 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601 (Cohort B)
- •Body Mass Index (BMI) >30 kg/m
- •Women with a BMI > 45 kg/m2 must be age < 60 and ability to perform physical activity must be confirmed
- •By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
- •Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel
- •Access to a personal computer
- •Live in the greater Kansas City Metropolitan Area
- •Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months. This consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week. Must be willing to perform unsupervised home exercise for the entire 6 months.
- •Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 3 months
- •Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 6 months and track food intake and exercise
- •Blood tests (Cohort A2) must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function as well as a hemoglobin of 10 or higher and/or performed within a year of study entry
排除标准
- •Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks
- •Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
- •Need for chronic immunosuppressive drugs
- •Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
- •Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
- •Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
- •Currently receiving investigational agents in a clinical trial
结局指标
主要结局
Adherence to supervised exercise sessions
时间窗: Week 12
Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.
次要结局
- Percent participants meeting physical activity goal(Week 12)
研究者
Carol Fabian, MD
Professor, Director Breast Cancer Prevention Unit
University of Kansas Medical Center
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Lifestyle Program (Scalable Nutrition and Physical Activity) for the Improvement of Nutrition and Physical Activity in Stage 0-III Breast Cancer SurvivorsAnatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage 0 Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8NCT04200482Fred Hutchinson Cancer Center90
已完成
2 期
An Extension Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 InfectionHepatitis C, ChronicNCT00292084BioWest Therapeutics Inc60
已完成
2 期
Study of E7389 for Advanced or Metastatic Breast CancerBreast CancerNCT00965523Eisai Co., Ltd.81
招募中
2 期
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate ThrombocytopeniaModerate ThrombocytopeniaMyelofibrosisNCT05980806Karyopharm Therapeutics Inc58
已完成
2 期
Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension)Duchenne Muscular DystrophyNCT00758225Santhera Pharmaceuticals21