Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT)

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

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

Treatments: Drug: Metformin; Behavioral: Self-control weight loss; Behavioral: Coach Directed Behavioral Weight Loss

Study type: Interventional

Funder types: Other

Identifiers

NCT02431676

IRB00035653 (Other Identifier)

J14148

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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121 participants in 3 patient groups

Self-Directed

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-control weight loss

Coach Directed Behavioral Weight Loss

Experimental group

Description:

The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight

Treatment:

Behavioral: Coach Directed Behavioral Weight Loss

Metformin

Experimental group

Description:

This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals

Treatment:

Drug: Metformin