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Completed

NCT Number: NCT02431676

Survivorship Promotion In Reducing IGF-1 Trial

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Melanoma of Skin Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Other Solid Malignant Tumors Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins ProHealth

Baltimore, Maryland, 21207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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.

Coach Directed Behavioral Weight Loss

Behavioral

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

Self-control weight loss

Behavioral

Primary outcomes

  1. IGF-1 Levels

    Time frame: 6 months

    Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.

Secondary outcomes

  1. IGF-1 Levels

    Time frame: 12 months

    IGF-1 at 12 months

  2. IGF-1 to IGFBP3 Level Ratio (Molar Ratio)

    Time frame: 6 months

    IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.

Other outcomes

  1. Weight Measured by Scale(Kg)

    Time frame: 6 and 12 months

    Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months

  2. Body Mass Index Measured by Scale and Tap(kg/m2)

    Time frame: 6 and 12 months

    Changes in BMI among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  3. EuroQol Score Assessed by Questionnaire

    Time frame: 6 and 12 months

    Changes in EuroQol score among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  4. Dietary Intake Assessed by Questionnaire

    Time frame: 6 and 12 months

    Changes in dietary intake among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  5. Physical Activity Amount Assessed by Questionnaire

    Time frame: 6 and 12 months

    Changes in physical activity amount among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  6. Fasting Glucose Levels

    Time frame: 6 and 12 months

    Changes in fasting glucose among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  7. Insulin Levels

    Time frame: 6 and 12 months

    Changes in insulin among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  8. Hemoglobin A1C Levels

    Time frame: 6 and 12 months

    Changes in Hb-A1C among Metformin arm, or Coach-directed behavioral weight loss arm versus the Self-control weight loss arm at 6 and 12 months.

  9. Interleukin (IL)-6 Levels

    Time frame: 6 and 12 months

    Changes in IL-6 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  10. Interleukin 8 Levels

    Time frame: 6 and 12 months

    Changes in IL-8 among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  11. C-reactive Protein (CRP) Levels

    Time frame: 6 and 12 months

    Changes in CRP among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

  12. Side Effects Assessed by Side Effect Questionnaire

    Time frame: 6 and 12 months

    assessing side effect among Metformin arm, or coach-directed behavioral weight loss arm versus the self-directed arm at 6 and 12 months.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Maryland Cigarette Restitution Fund

Registry information

Official study title

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

Acronym: SPIRIT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 1, 2015
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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