Survivorship Promotion In Reducing IGF-1 Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Colorectal Cancer, Cervical Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Endometrial Cancer, Kidney Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | May 2015 |
| End Date: | December 2019 |
Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
This is a prospective, single-center randomized trial with three arms, and an allocation
ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and
coach-directed behavioral weight loss versus self-directed weight loss on IGF-1 and IGF-1 to
THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed
Behavioral Weight Loss arm is a web-based remote delivery and communication system that
promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of
oral metformin. This is a secondary prevention study for men and women who have survived
solid malignant tumors
ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and
coach-directed behavioral weight loss versus self-directed weight loss on IGF-1 and IGF-1 to
THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed
Behavioral Weight Loss arm is a web-based remote delivery and communication system that
promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of
oral metformin. This is a secondary prevention study for men and women who have survived
solid malignant tumors
Inclusion Criteria:
- Women and men ages 18 or older
- Have been previously diagnosed with a malignant solid tumor, completed their required
surgical, and/or chemotherapy and/or radiation curative intent therapy at least three
months prior to enrollment, and have an anticipated treatment-free life span of 12
months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast
cancer in women and anti- LHRH therapy for prostate cancer in men will be permitted.
- Have a BMI of 25 kg/m2 or greater and weight <=400 lbs.
- Willingness to accept randomization to each of the three arms
- Willingness to change diet, physical activity, and weight
- Regular access to computer with a reliable Internet connection
- Ability to send and receive emails
- Ability to complete online forms
- Access to phone
- Willingness to provide written informed consent
Exclusion Criteria:
- Women who are breastfeeding, pregnant, or planning pregnancy within the next year
- Medication-treated diabetes
- Fasting blood glucose >=200 mg/dL, or fasting blood glucose >=126 and <200 mg/dL and
HbA1C >=7%
- Current or prior regular use of metformin within the past 3 months
- Uncontrolled concurrent medical condition likely to limit compliance with the study
interventions
- Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months
or less prior to the proposed intervention date
- Have a prior history of lactic acidosis by self-report
- Prior or planned bariatric surgery
- Have significant renal disease or dysfunction defined as eGFR<45
- Have significant hepatic dysfunction (AST/ALT ≥ 2 x ULN or reported liver disease)
- Self-reported average consumption of > 14 alcoholic drink per week
- Currently enrolled or planned to enroll in weight loss program
- Hemoglobin <9 g/dl
- Platelet count <100
- WBC <2.5
- Plans to relocate from the area within one years
- Use of prescription weight loss medication(s) (e.g., lorcaserin,
topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including
off label use of drugs for weight loss or over-the-counter weigh loss medications such
as Orlistat within the past 6 months.
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