ACTIVE_NOT_RECRUITING

Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer

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Conditions

Lung Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial determines the effect of metformin extended release on the risk for developing lung cancer in overweight/obese patients that are at high-risk for developing lung cancer. Metformin is widely used to treat type II diabetes and has a long history of safety and minimal side effects. At similar dosage, the drug may have potential anti-cancer activity. Metformin use has been associated with improved survival in patients with non-small cell lung carcinoma, a specific type of lung cancer, and it has also been shown to enhance immune mobilization against tumors. This trial aims to see whether metformin extended release as a preventative treatment may lower the chance of developing lung cancer, and whether it may help patients' immune system learn ("reprogram") to lower a certain type of immune cell (called regulatory T cells) that are linked to tumor development.

Official Title

Metformin for Chemoprevention of Lung Cancer in High-Risk Overweight or Obese Individuals

Quick Facts

Study Start:2022-09-09
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04931017

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.

Ages Eligible for Study:30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Former smokers (male and female) with a \>= 20 pack year smoking history
  2. * Quit smoking \>= 12 months prior to enrollment
  3. * Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCOm2012) Lung Cancer Risk Prediction Score \> 1.34%
  4. * Overweight
  5. * Body mass index (BMI) \> 25 and
  6. * Waist circumference
  7. * Female \> 88 cm (35")
  8. * Male \> 102 cm (40")
  9. * Age greater than 30 years. Participants younger than 30 years are unlikely to accrue enough smoking exposure followed by enough time after quitting (\>12 months) to qualify
  10. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  11. * Leukocytes \>= 3,000/microliter
  12. * Absolute neutrophil count (ANC) \>= 1,000/microliter
  13. * Platelets \>= 100,000/microliter
  14. * Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
  15. * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x IULN
  16. * Estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73 m\^2 (eGFR will be calculated using the equation Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] creatinine)
  17. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured
  18. * Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
  19. * The effects of metformin ER on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  20. * Ability to understand and the willingness to sign a written informed consent document
  1. * Current or previous diagnosis of diabetes mellitus (type I or type II diabetes)
  2. * Use of metformin within the past 2 years
  3. * Use of GLP-1 agonists within 6 weeks prior to enrollment
  4. * Glycosylated hemoglobin A1C (HbA1c) \> 8%
  5. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin ER
  6. * Participants currently using immunosuppressive medication, including systemic steroids (not inhalational) and episodic use of inhaled steroids are excluded from this trial due to the potential impact of these treatments on the primary trial endpoint
  7. * Participants receiving any other investigational agents
  8. * History of chronic alcohol use or abuse defined by any one of the following:
  9. * Average consumption of 3 or more alcohol containing beverages daily in the past 12 months
  10. * Consumption of 7 or more alcoholic beverages within a 24 hour period in the past 12 months
  11. * Acute or chronic liver disease, evidence of hepatitis (infectious or autoimmune), cirrhosis or portal hypertension
  12. * History of or current condition predisposing to increased risk for lactic acidosis such as: severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV), metabolic acidosis, severe liver disease, or renal failure
  13. * Uncontrolled intercurrent illness or psychiatric illness/social situations that would or limit compliance with study requirements
  14. * Pregnant women are excluded from this study. Metformin ER is a class B agent that was not teratogenic in rats and rabbits at doses representing 3 and 6 times the maximum recommended human daily dose of 2000 mg; however, animal reproduction studies are not always predictive of human response. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with metformin ER, breastfeeding should be discontinued if the mother is treated with metformin ER
  15. * Biopsy with invasive carcinoma of the lung or carcinoma in situ
  16. * Participants with prior stage 1 non-small cell lung cancer (NSCLC) diagnosis are allowed to participate, as long as there has been 12 months since the completion of cancer treatment prior to enrollment with no evidence of recurrence or second primary cancer

Contacts and Locations

Principal Investigator

Saikrishna S Yendamuri
PRINCIPAL_INVESTIGATOR
Roswell Park University

Study Locations (Sites)

Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Saikrishna S Yendamuri, PRINCIPAL_INVESTIGATOR, Roswell Park University

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 Registration Dates

Study Start Date2022-09-09
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2022-09-09
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Carcinoma