Survivorship Promotion In Reducing IGF-1 Trial

Study Overview
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Brief Summary
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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 insulin-like growth factor (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

Official Title
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Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors

Conditions
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Breast Cancer, Prostate Cancer, Lung Cancer, Colon Cancer, Melanoma of Skin, Endometrial Cancer, Liver Cancer, Pancreatic Cancer, Rectal Cancer, Kidney Cancer, Other Solid Malignant Tumors

Intervention / Treatment
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* Drug: Metformin
* Behavioral: Coach Directed Behavioral Weight Loss
* Behavioral: Self-control weight loss


Participation Criteria
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Eligibility Criteria
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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- Luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted. Have a BMI of 25 kg/m^2 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 Estimated glomerular filtration rate (eGFR)<45 Have significant hepatic dysfunction [Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≥ 2 x upper limit of normal (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 White blood cell count (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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-Directed<br>In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management. | Behavioral: Self-control weight loss<br> <br> |
| Experimental: Coach Directed Behavioral Weight Loss<br>The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight | Behavioral: Coach Directed Behavioral Weight Loss<br>* Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals<br>|
| Experimental: Metformin<br>This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals | Drug: Metformin<br>* Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 Levels | Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 Levels | IGF-1 at 12 months | 12 months | 
| IGF-1 to IGFBP3 Level Ratio (Molar Ratio) | IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months. | 6 months |