RECRUITING

A Study of Exercise and Pharmacologic Intervention on Systemic Inflammation

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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 is a study assessing the feasibility of performing an anti-aging intervention which is a combination of an exercise regimen, spermidine supplementation, and either rapamycin or lamivudine.

Official Title

A Phase 1b, Multi-cohort Clinical Trial Assessing Safety and Feasibility of Exercise and Spermidine Administered in Conjunction With Lamivudine (RTi) or Rapamycin (mTORi) to Assess Impact on Dynamic Changes of Inflammation and Aging

Quick Facts

Study Start:2025-08-25
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07058974

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:65 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 65-80 years old
  2. * Current or former smokers
  3. * BMI 25-32
  4. * No cancer requiring active therapy within the last 2 years
  5. * No autoimmune disease requiring disease modifying agents
  6. * No patients with CKD stage 3/4 or ESRD
  7. * No class 3 or 4 heart failure
  1. * Patients may not have cancer requiring active therapy within the last 2 years
  2. * Patients may not have autoimmune disease requiring disease modifying agents
  3. * Patients may not be receiving immune modifying biologic therapies
  4. * Patients may not have chronic kidney disease stage 3/4 or end stage renal disease
  5. * Patients may not have a known history of metabolic dysfunction-associated steatohepatitis
  6. * Patients may not have a known chronic viral infection such as HIV or active Hepatitis B or C, or a known history of genital HSV. Patients who have spontaneously or through treatment cleared hepatitis B or C are candidates for the trial. If Hepatitis B core ab is positive must document a negative PCR.
  7. * Patients may not have class 3 or 4 heart failure, or have experienced a myocardial infarction or cerebrovascular event in the past 6 months
  8. * Patients may not have uncontrolled diabetes mellitus
  9. * Patients may not have a history of clinically significant interstitial lung disease (ILD).
  10. * Patients may not have clinically significant active wound healing due to recent injury or surgery
  11. * Patients may not have signs or symptoms of clinically significant acute infectious illness on screening laboratory testing or physical examination.
  12. * Patients may not have evidence of active or latent tuberculosis
  13. * Patients may not have nephrotic range proteinuria on screening labs
  14. * Patients may not have received a live virus within one month of study initiation.
  15. * Patients cannot have uncontrolled hypertension (persistent systolic \>160; diastolic \>100)
  16. * Patients with an inherited primary immunodeficiency
  17. * Patients may not have a history of, or current evidence of, clinically significant chronic liver disease
  18. * Patients may not be receiving any chronic immunosuppressive therapy.
  19. * Patients may not be receiving medications that could increase rapamycin blood concentrations, such as strong inhibitors and inducers of CYP3A4 and/or P-gp (ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin; rifampin or rifabutin), bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, protease inhibitors, metoclopramide, nicardipine, troleandomycin, verapamil. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
  20. * Patients may not be receiving medications that could decrease rapamycin blood concentrations, such as: carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.
  21. * Patients may not be receiving medications known to cause angioedema with concomitant use of rapamycin, such as angiotensin-converting enzyme (ACE) inhibitors. Furthermore, these medications may not be used during the study if patient is assigned to the rapamycin cohort.

Contacts and Locations

Study Contact

Thomas Marron, MD, PhD
CONTACT
(212) 824-9472
thomas.marron@mssm.edu

Principal Investigator

Thomas Marron, MD, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Hospital
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Thomas Marron, MD, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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 Date2025-08-25
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2025-08-25
Study Completion Date2026-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Smokers
  • Former Smokers