RECRUITING

Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

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Conditions

Cystic Fibrosis

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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

The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.

Official Title

Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

Quick Facts

Study Start:2023-04-20
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05639556

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.
  2. * Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.
  3. * Both cohorts match by age, gender, race and CFTR genotype severity.
  1. * No prior solid organ transplantation
  2. * No initiation of an investigation drug within 28 days prior to and including Visit 1
  3. * No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
  4. * No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Visit 1.
  5. * For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
  6. * No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit.
  7. * Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.

Contacts and Locations

Study Contact

Judy Sibayan
CONTACT
(813) 975-8690
jsibayan@jaeb.org

Principal Investigator

Adam Stein
PRINCIPAL_INVESTIGATOR
Northwestern
Jessica Alvarez
PRINCIPAL_INVESTIGATOR
Emory University
Melissa Putman
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85724
United States
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
United States
Yale University School of Medicine
New Haven, Connecticut, 06520
United States
Emory
Atlanta, Georgia, 30324
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Kentucky
Lexington, Kentucky, 40508
United States
Tulane University
New Orleans, Louisiana, 70112
United States
John Hopkins University
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
United States
Boston Children's Hospital and Brigham and Women's CF Center
Boston, Massachusetts, 02120
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Washington University School of Medicine (St. Louis)
Saint Louis, Missouri, 63110
United States
New York Medical College (NYMC)
Hawthorne, New York, 10532
United States
Northwell LIJ Adult Cystic Fibrosis Center
New Hyde Park, New York, 11040
United States
University of Cincinnati
Cincinnati, Ohio, 45220
United States
University Hospitals
Cleveland, Ohio, 44106
United States
University of Oklahoma Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Baylor University
Houston, Texas, 77030
United States
University of Virginia Cystic Fibrosis Center
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

  • Adam Stein, PRINCIPAL_INVESTIGATOR, Northwestern
  • Jessica Alvarez, PRINCIPAL_INVESTIGATOR, Emory University
  • Melissa Putman, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Date2023-04-20
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-04-20
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis