Randomized Phase II Study of Exercise and Metformin in Colorectal and Breast Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Change in Fasting Insulin Level
研究概览
简要总结
Metformin is a medication that is commonly used in the treatment of diabetes. Recently small studies in cancer patients without diabetes suggest that metformin may benefit in lowering insulin levels. In those studies of patients with cancer but not diabetes, glucose (or sugar) levels in the blood are generally no lowered. Insulin and insulin-like growth factors affect the growth of cancer cells.
This randomized study will compare different interventions; exercise, exercise and metformin, metformin alone, or a control arm. The investigators are not directly testing how either exercise or metformin affects your disease. The investigators are testing how they affect insulin levels in your body as well as other blood markers. The investigators believe that these blood tests may either be related to cancer recurrences or be an early sign of cancer recurrences and they are testing how both exercise and metformin may change those markers.
详细描述
Subjects will be randomized into one of four groups: exercise training, exercise training and metformin, metformin alone, or control arm. All subjects will have lifestyle measurements, interviews regarding activity level, diet questionnaires, and blood tests.
Subjects randomized to exercise training will participate in two supervised exercise sessions per week with an exercise physiologist for 3 months. They will also be asked to exercise on their own for up to an additional 120 minutes each week.
Subjects randomized to exercise training and metformin will participate in two supervised exercise sessions per week and will take metformin. Metformin will be taken once daily for the first two weeks and then twice daily for 3 months.
Subjects randomized to metformin will take metformin once daily for the first two weeks and then twice daily.
Subjects on the control arm will receive a packet of educational information on nutrition and physical activity developed by the National Cancer Institute and American Cancer Society. In addition to education information, they will be offered two supervised sessions with an exercise physiologist as well as a pedometer 3 months after enrollment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage I-III colorectal or breast cancer
- •Undergone curative-intent complete surgical resection and completed all adjuvant therapy (if indicated) at least 2 months prior to enrollment
- •Note: Breast cancer subjects on hormonal therapy or trastuzumab only therapy and colorectal cancer subjects on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in CALGB 80702 receiving only celecoxib/placebo) are eligible.
- •Participants will be allowed to receive concomitant adjuvant endocrine therapy for breast cancer; however, all endocrine agents must be initiated at least 1 month prior to enrollment in the study and continued throughout the duration of study participation.
- •Less than 120 minutes of exercise per week
- •Approval by oncologist or surgeon
- •English speaking and able to read English
- •No planned surgery anticipated in the 3 month intervention period
- •At least one month from any major surgery to start of intervention including colostomy reversal
排除标准
- •Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)
- •Metastatic disease
- •Scheduled to receive any form of further adjuvant cancer therapy
- •Currently on medication for diabetes treatment
- •Pregnant or breast-feeding
- •Any condition associated with increased risk of metformin-associated lactic acidosis (prior renal failure or liver failure, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
- •Known hypersensitivity or intolerance to metformin
研究组 & 干预措施
Exercise training
Exercise training with exercise physiologist
干预措施: Exercise training (Behavioral)
Exercise training with metformin
Exercise training with exercise physiologist with oral metformin
干预措施: Exercise training (Behavioral)
Exercise training with metformin
Exercise training with exercise physiologist with oral metformin
干预措施: Metformin (Drug)
Metformin
Metformin
干预措施: Metformin (Drug)
Control
Educational information
干预措施: Educational information (Other)
结局指标
主要结局
Change in Fasting Insulin Level
时间窗: 0 and 3 months (change between 0 and 3 months)
Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting insulin level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.
次要结局
- Changes in Other Insulin-Related Biomarkers(0 and 3 months (change between 0 and 3 months))
- Change in Fasting Glucose Level(0 and 3 months (change between 0 and 3 months))
研究者
Jeffrey A. Meyerhardt, MD
Principal Investigator
Dana-Farber Cancer Institute