Survivorship Promotion In Reducing IGF-1 Trial

NCT02431676 | Completed Phase 2 Results DMC

• 2 other identifiers: J14148IRB00035653
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• IGF-1 Levels

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

  6 months

Secondary Outcomes (2)

• IGF-1 Levels

  12 months

• IGF-1 to IGFBP3 Level Ratio (Molar Ratio)

  6 months

Other Outcomes (12)

• Weight Measured by Scale(Kg)

  6 and 12 months

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

  6 and 12 months

• EuroQol Score Assessed by Questionnaire

  6 and 12 months

Study Arms (3)

Self-Directed

ACTIVE COMPARATOR

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

Coach Directed Behavioral Weight Loss

EXPERIMENTAL

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

Behavioral: Coach Directed Behavioral Weight Loss

Metformin

EXPERIMENTAL

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

Drug: Metformin

Interventions

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.

Metformin

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

Coach Directed Behavioral Weight Loss

Self-control weight loss BEHAVIORAL

Self-Directed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Johns Hopkins ProHealth

Baltimore, Maryland, 21207, United States

Location

Related Publications (5)

• Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller E, White K, Appel LJ, Mueller NT. Increases in Circulating and Fecal Butyrate are Associated With Reduced Blood Pressure and Hypertension: Results From the SPIRIT Trial. J Am Heart Assoc. 2022 Jul 5;11(13):e024763. doi: 10.1161/JAHA.121.024763. Epub 2022 Jun 22.

  PMID: 35730613 DERIVED

• Tilves C, Yeh HC, Maruthur N, Juraschek SP, Miller ER, Appel LJ, Mueller NT. A behavioral weight-loss intervention, but not metformin, decreases a marker of gut barrier permeability: results from the SPIRIT randomized trial. Int J Obes (Lond). 2022 Mar;46(3):655-660. doi: 10.1038/s41366-021-01039-2. Epub 2022 Jan 6.

  PMID: 34987204 DERIVED

• Hu JR, Yeh HC, Mueller NT, Appel LJ, Miller ER 3rd, Maruthur NM, Jerome GJ, Chang AR, Gelber AC, Juraschek SP. Effects of a Behavioral Weight Loss Intervention and Metformin Treatment on Serum Urate: Results from a Randomized Clinical Trial. Nutrients. 2021 Jul 31;13(8):2673. doi: 10.3390/nu13082673.

  PMID: 34444833 DERIVED

• Mueller NT, Differding MK, Zhang M, Maruthur NM, Juraschek SP, Miller ER 3rd, Appel LJ, Yeh HC. Metformin Affects Gut Microbiome Composition and Function and Circulating Short-Chain Fatty Acids: A Randomized Trial. Diabetes Care. 2021 Jul;44(7):1462-1471. doi: 10.2337/dc20-2257. Epub 2021 May 18.

  PMID: 34006565 DERIVED

• Juraschek SP, Plante TB, Charleston J, Miller ER, Yeh HC, Appel LJ, Jerome GJ, Gayles D, Durkin N, White K, Dalcin A, Hermosilla M. Use of online recruitment strategies in a randomized trial of cancer survivors. Clin Trials. 2018 Apr;15(2):130-138. doi: 10.1177/1740774517745829. Epub 2018 Jan 24.

  PMID: 29361843 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Colonic Neoplasms; Melanoma; Endometrial Neoplasms; Liver Neoplasms; Pancreatic Neoplasms; Rectal Neoplasms; Kidney Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Jessica Yeh
• Organization: Johns Hopkins University

hyeh1@jhmi.edu

410-614-4316

Study Officials

• Jessica Yeh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: May 1, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 28, 2024
• Results First Posted: September 16, 2020

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)