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Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02431676
First received: April 21, 2015
Last updated: August 12, 2016
Last verified: August 2016
  Purpose
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 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

Condition Intervention Phase
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
Drug: Metformin
Behavioral: Coach Directed Behavioral Weight Loss
Behavioral: Self-control weight loss
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • IGF-1 levels [ Time Frame: 6 months ]
    IGF-1 levels among coach-directed behavioral weight loss arm or Metformin arm compare to the self-directed weight loss arm at 6 months

  • IGF-1 levels :IGFBP3 levels (Ratio) [ Time Frame: 6 months ]
    IGF-1: IGFBP3 ratio among coach-directed behavioral weight loss arm or Metformin arm compare than those in the self-directed weight loss arm at 6 months


Secondary Outcome Measures:
  • IGF-1 levels [ Time Frame: 12 months ]
    IGF-1the Metformin arm or Coach-directed behavioral weight loss arm compare to those in the self-directed weight loss arm at 12 months

  • IGF-1 levels :IGFBP3 levels (Ratio) [ Time Frame: 12 months ]
    IGF-1:IGFBP3 among the Metformin arm or coach-directed behavioral weight loss arm compare to those in the self-directed weight loss arm at 12 months


Other Outcome Measures:
  • Weight measured by scale(Kg) [ Time Frame: 6 & 12 months ]
    Changes in weight among Metformin group, or coach-directed Groups versus the self-directed arm at 6 and 12 months

  • Body Mass Index measured by scale and tap(kg/m2) [ Time Frame: 6 & 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.

  • EuroQol score assessed by questionnaire [ Time Frame: 6 & 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Interleukin 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 120
Study Start Date: May 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Self-Directed
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
Experimental: Coach Directed Behavioral Weight Loss
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Behavioral: Coach Directed Behavioral Weight Loss
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
Experimental: Metformin
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Drug: Metformin
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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- LHRH therapy for prostate cancer in men will be permitted.
  • Have a BMI of 25 kg/m2 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 eGFR<45
  • Have significant hepatic dysfunction (AST/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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02431676

Contacts
Contact: Karen A White 410-281-1600 spirit@jhmi.edu
Contact: Jeanne Charleston 410-281-1600 jeannec@jhmi.edu

Locations
United States, Maryland
Johns Hopkins ProHealth Recruiting
Baltimore, Maryland, United States, 21207
Contact: Karen White    410-281-1600    spirit@jhmi.edu   
Contact: Jeanne Charleston    410-281-1600    jeannec@jhmi.edu   
Principal Investigator: Jessica Yeh, PhD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Jessica Yeh, PhD Johns Hopkins University
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02431676     History of Changes
Other Study ID Numbers: J14148  IRB00035653 
Study First Received: April 21, 2015
Last Updated: August 12, 2016

Additional relevant MeSH terms:
Pancreatic Neoplasms
Rectal Neoplasms
Endometrial Neoplasms
Liver Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Liver Diseases
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma

ClinicalTrials.gov processed this record on February 20, 2017