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Weight Loss or Metformin Hydrochloride in Reducing IGF-1 Hormone in Cancer Survivors

Trial Status: Closed to Accrual and Intervention

This clinical trial compares how well weight loss or metformin hydrochloride work in reducing levels of the hormone insulin-like growth factor 1 (IGF-1) in cancer survivors, and how well a coached weight loss program works compared with self-directed weight loss. High levels of IGF-1 is linked to the growth of cancer or the return of cancer in cancer survivors. Studying different strategies of weight loss and medication with metformin hydrochloride to see how they affect IGF-1 levels may help doctors learn more about IGF-1 and the best way to lower levels of this hormone.

Inclusion Criteria

  • 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 body mass index (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
  • Non-fasting blood glucose >= 200 mg/dL, or hemoglobin A1C (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 aminotransferase [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
  • White blood cell (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

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Hsin Chieh Yeh
Phone: 410-614-4316

PRIMARY OBJECTIVES:

I. Test the hypothesis that participants in the coach-directed behavioral weight loss arm will experience greater decreases in IGF-1 and IGF-1:insulin-like growth factor binding protein 3 (IGFBP3) than those in the self-directed weight loss arm at 6 months.

II. Test the hypothesis that participants in the metformin arm will experience greater decreases in IGF-1 and IGF-1:IGFBP3 than those in the self-directed weight loss arm at 6 months.

SECONDARY OBJECTIVES:

I. Test the hypothesis that participants in the metformin arm will experience greater decreases in IGF-1 and IGF-1:IGFBP3 than those in the coach-directed behavioral weight loss arm at 6 months.

II. Determine the effects of coach-directed behavioral weight loss and metformin separately on IGF-1 and IGF-1:IGFBP3 at 12 months (Aims 1 - 3 at 12 months).

III. Determine the effects of coach-directed behavioral weight loss and metformin separately on the following outcomes at 6 and 12 months: weight, body mass index; European Quality of Life (EuroQol); dietary intake and physical activity; glucose, insulin, hemoglobin A1c; interleukin (IL)-6, IL-8, c-reactive protein (CRP); side effects questionnaire.

IV. Conduct exploratory analyses (Aims 1 - 5 above) in key, pre-specified subgroups, defined by sex, race, type of cancer, and baseline levels of IGF-I and the IGF-1:IGFBP-3 ratio.

V. Explore the association of physical activity levels with IGF-1 and the IGF-1:IGFBP-3 ratio.

VI. Collect and store specimens of blood and stool for other assays.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM A (SELF-DIRECTED WEIGHT LOSS): Participants continue to receive care from their primary care provider or oncologist. Participants also undergo a visit with a staff member after randomization, and receive the National Institutes of Health booklets "Aim for a Healthy Weight" and "What I need to know about Physical Activity and Diabetes." Participants also receive a link to the Centers for Disease Control and Prevention (CDC) website "Healthy Weight."

ARM B (COACH-DIRECTED BEHAVIORAL WEIGHT LOSS): Participants undergo the Remote Lifestyle Coaching intervention, comprising coaching from a Johns Hopkins coach and access to a study website for learning and self-monitoring. Coaching sessions are weekly for 3 months and then monthly for months 4-12. Participants receive automated e-mail reminders after 7 days of no website login, and personal follow-up from their coach via email or call if there is no login within 14 days. Participants also receive bathroom scales and track calories using the study website/phone app.

ARM C (METFORMIN HYDROCHLORIDE): Participants continue to receive care from their primary care provider, oncologist, or other provider, and receive medication-related education and counseling from a study staff member following randomization. Participants also receive metformin hydrochloride orally (PO) twice (BID) or thrice (TID) daily.

After completion of study, patients are followed up at 3, 6, and 12 months.

Trial Phase Phase II

Trial Type Prevention

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Hsin Chieh Yeh

  • Primary ID J14148
  • Secondary IDs NCI-2015-01160, CRMS-60415, IRB00035653
  • Clinicaltrials.gov ID NCT02431676