RECRUITING

Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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Conditions

Chronic Fatigue SyndromeMyalgic Encephalomyelitis

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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

Chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. The present exploratory clinical trial aims to advance our understand of the mechanisms of in situ GSH synthesis control through assessment of the response of brain GSH and plasma markers of oxidative stress to different doses of NAC in comparison to placebo, as a potential treatment for ME/CFS that would provide neuroprotection against oxidative stress by restoring cortical GSH reserves. If successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto the mechanisms of action of NAC in brain GSH restoration, which could open a new avenue for the development of potentially effective treatments for a disorder, ME/CFS, that currently has none.

Official Title

Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Through Dose Response and Treatment Target Engagement

Quick Facts

Study Start:2020-09-01
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04542161

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:21 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or females, ages 21 to 60 years (inclusive).
  2. * Baseline GSH levels at or less than a predefined cutoff value.
  3. * Primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
  4. * Willing and capable of providing informed consent.
  1. * Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders.
  2. * Any significant neurological illness or impairment.
  3. * Other unstable medical conditions (asthma, hypertension, endocrine or metabolic disease, etc).
  4. * History alcohol abuse.
  5. * Positive urine toxicology at screening and on days of assessments.
  6. * Positive pregnancy test at screening or on days of assessments.
  7. * Contra-indication for clinical MRI scan (e.g., pacemaker, metallic prosthesis).
  8. * Baseline GSH levels higher than a predefined cutoff value.

Contacts and Locations

Study Contact

Xiangling Mao, MS
CONTACT
2127462632
xim2004@med.cornell.edu

Principal Investigator

Dikoma C. Shungu, Ph.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Dikoma C. Shungu, Ph.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell 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 Date2020-09-01
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis