Survivorship Promotion In Reducing IGF-1 Trial (SPIRIT)

August 4, 2024 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21207
        • Johns Hopkins ProHealth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IGF-1 Levels
Time Frame: 6 months
Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IGF-1 Levels
Time Frame: 12 months
IGF-1 at 12 months
12 months
IGF-1 to IGFBP3 Level Ratio (Molar Ratio)
Time Frame: 6 months
IGF-1 level to IGFBP3 level ratio (molar ratio) at 6 months.
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 and 12 months
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.
6 and 12 months
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.
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.
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.
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.
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.
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.
6 and 12 months
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.
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.
6 and 12 months
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.
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.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maryland Cigarette Restitution Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Yeh, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • J14148
  • IRB00035653 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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