AzTrials
AzTrials

Breast CancerPhase 2SPIRITNCT02431676

Survivorship Promotion In Reducing IGF-1 Trial

A Phase 2 study testing Metformin and Coach Directed Behavioral Weight Loss in people with Breast Cancer and Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Prostate Cancer, Lung Cancer
What is being tested?
Metformin and Coach Directed Behavioral Weight Loss
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteUnited States
Study dates
May 2015to Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Ability to send and receive emails
  • Ability to complete online forms
  • Access to phone
  • Willingness to provide written informed consent

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins ProHealth

    Baltimore, Maryland, 21207

Other trials in United States

About this study

Official title: 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

Being tested
Metformin, Coach Directed Behavioral Weight Loss, Self-control weight loss
Medical subject headings
Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Colonic Neoplasms, Melanoma, Endometrial Neoplasms, Liver Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    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 LossBehavioural

    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 lossBehavioural

Study groups in NCT02431676
Study groupRoleWhat they receive
Self-DirectedActive comparatorIn this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
Receives: Behavioral: Self-control weight loss
Coach Directed Behavioral Weight LossExperimentalThe Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
Receives: Behavioral: Coach Directed Behavioral Weight Loss
MetforminExperimentalThis group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IGF-1 Levels

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

    Measured: 6 months

Secondary outcomes (2)

  1. IGF-1 Levels

    IGF-1 at 12 months

    Measured: 12 months

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

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02431676
Sponsor's protocol ID
J14148
Other IDs
IRB00035653
Acronym
SPIRIT
Status last verified
Aug 2024
First submitted
21 Apr 2015
Last updated
28 Aug 2024
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35730613

  • 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.

    PubMed 34987204

  • 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.

    PubMed 34444833

  • 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.

    PubMed 34006565

  • 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.

    PubMed 29361843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin and Coach Directed Behavioral Weight Loss in people with Breast Cancer and Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IGF-1 Levels (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02431676, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in