Recruiting

Muscle Health Endotypes

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07531498

Conditions

Muscle Weakness

Low Muscle Mass

Sarcopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Multimodal Muscle Imaging and Functional Assessment

Multimodal Muscle Imaging and Neuromuscular Assessment

Comprehensive Muscle Phenotyping

Integrated Neuromuscular and Imaging Evaluation

Study Details

Brief summary:

Childhood cancer survivors experience premature declines in muscle mass, strength, and physical function that contribute to morbidity and early mortality. The biological mechanisms driving these impairments are heterogeneous and poorly understood. This observational study aims to characterize distinct muscle health endotypes in adult survivors of childhood cancer using advanced imaging, neuromuscular testing, and functional assessment. Survivors with reduced muscle health and community controls will undergo multimodal magnetic resonance imaging and spectroscopy, nerve conduction studies, surface electromyography, body composition assessment, and physical performance testing during a single study visit integrated into an ongoing cohort evaluation. Identifying mechanistic endotypes of impaired muscle health will support development of targeted interventions to preserve function and improve long-term outcomes in childhood cancer survivors.

Primary Objective:

\- Characterize reduced muscle health endotypes in childhood cancer survivors.

Secondary Objective:

\- Identify specific treatment and lifestyle related risk factors for each reduced muscle health endotype.

Exploratory Objective:

\- Host germline genetics will be associated with specific muscle endotypes.

Conditions

Muscle Weakness

Low Muscle Mass

Sarcopenia

Study ID

NCT07531498

Start date

Oct 1, 2026

Status verified date

Aug, 2026

Completion date

May, 2031

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 years old or older at time of consent and enrolled in SJLIFE.
  • Participant (100 per group for a total of 400) is/has:
  • Group 1: No cancer history
  • Group 2: Age and sex specific relative lean mass z-score of less than -0.5 OR age and sex specific hand grip or isokinetic (60 degrees/sec) quadriceps strength z-score of <-0.5 AND exposure to a peripheral neurotoxin.
  • Group 3: Age and sex specific relative lean mass z-score of less than -0.5 OR age and sex specific hand grip or isokinetic (60 degrees/sec) quadriceps strength z-score of <-0.5 AND NOT exposed to a peripheral neurotoxin.
  • Group 4: Age and sex specific relative lean mass z-score of less than -0.5 AND age and sex specific hand grip strength or isokinetic (60 degrees/sec) quadriceps strength z-score of <-0.5 REGARDLESS of exposure status.
  • Participant or legal guardian is able and willing to give informed consent.

Exclusion Criteria:

  • Presence of implanted medical devices or metal that would interfere with MRI or MRS.
  • Female Participant is pregnant.
  • Body weight exceeding 300 pounds, due to MRI restrictions.
  • Inability to lie flat on his/her back for 90 minutes or longer for MRI.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  • Presence of known radiation-induced nerve injury.
  • Prescence of pre-existing neurologic (non-cancer related) or who develop chronic neurologic disorders (i.e. Charcot Marie Tooth Disease, Downs, congenital brain injury).
  • Participation on a lifestyle or medication clinical trial within the past 1 year.

Study Design

Enrollment

533 participants

Anticipated

Interventions and Outcome Measures

Arms

Community Controls

Adults with no history of cancer recruited from the community or non-first-degree relatives of St. Jude patients.

Survivors With Low Lean Mass or Weakness and Peripheral Neurotoxin Exposure

Adult childhood cancer survivors with low lean mass and/or muscle weakness and documented exposure to peripheral neurotoxic therapies.

Survivors With Low Lean Mass or Weakness Without Peripheral Neurotoxin Exposure

Adult childhood cancer survivors with low lean mass and/or muscle weakness and no history of exposure to peripheral neurotoxic therapies.

Survivors With Low Lean Mass and Muscle Weakness (Regardless of Neurotoxin Exposure)

Adult childhood cancer survivors meeting criteria for both low lean mass and muscle weakness, irrespective of treatment exposure.

Interventions

Multimodal Muscle Imaging and Functional Assessment

Participants undergo comprehensive muscle phenotyping, including magnetic resonance imaging (MRI) to assess muscle cross-sectional area and fat fraction; magnetic resonance spectroscopy (¹H MRS and ³¹P MRS) to evaluate skeletal muscle mitochondrial energetics; body composition assessment using dual energy X ray absorptiometry (DXA) and bioelectrical impedance analysis (BIA); nerve conduction velocity testing; surface electromyography (EMG); and standardized physical performance testing.

Multimodal Muscle Imaging and Neuromuscular Assessment

Participants complete advanced neuromuscular and imaging assessments, including MRI-based evaluation of muscle structure and fat infiltration; magnetic resonance spectroscopy to assess mitochondrial oxidative metabolism; DXA and BIA for lean mass measurement; nerve conduction studies; surface electromyography during submaximal and maximal muscle activation; and physical function testing, performed during a single study visit.

Comprehensive Muscle Phenotyping

Participants undergo protocol-defined observational assessments including MRI and MRS of skeletal muscle, body composition analysis via DXA and BIA, neuromuscular testing with nerve conduction velocity and surface electromyography, and functional performance evaluations to characterize muscle health and underlying biological mechanisms.

Integrated Neuromuscular and Imaging Evaluation

Participants receive integrated phenotyping of muscle health using multimodal MRI and MRS imaging, neuromuscular testing with EMG and nerve conduction velocity, body composition assessment, and standardized physical performance measures to identify muscle aging endotypes.

Primary outcome measure

  • Nerve conduction velocity (NCV) at rest and Electromyography (EMG) during submaximal and maximal force generation [ Time Frame: Baseline ]
  • Creatinine recovery post exercise with magnetic resonance imaging (MRI) [ Time Frame: Baseline ]
  • Intramyocellular and extramyocellular fat fraction in muscle during magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Kirsten Ness, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Kirsten Ness, PhD

888-226-4343referralinfo@stjude.org

Principal Investigator:

Kirsten Ness, PhD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Childhood Cancer Survivors
  • Adult Survivors of Childhood Cancer
  • Neuromuscular Function
  • Muscle Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-09-01.