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The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer

Sponsor
City of Hope Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05023993
Collaborator
National Cancer Institute (NCI) (NIH)
20
Enrollment
1
Location
2
Arms
27.3
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise Intervention
  • Dietary Supplement: Nicotinamide Riboside
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. Evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (CCS) with a history of prediabetes.
EXPLORATORY OBJECTIVES:

  1. Describe the association between patient demographics and treatment exposures and subsequent hyperglycemia and skeletal muscle health in childhood cancer survivors.

  2. Describe the effect of exercise with or without nicotinamide riboside (NR) on hyperglycemia and skeletal muscle health in CCS with a history of prediabetes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.

ARM II: Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside orally (PO) daily for 6 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Exercise and Nicotinamide Riboside on Muscle Health and Insulin Resistance in Adult Survivors of Childhood Cancer With Prediabetes: A Pilot Feasibility Study
Actual Study Start Date :
Jun 23, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (home exercise)

Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.

Other: Exercise Intervention
Complete home exercise
Experimental: Arm II (home exercise, nicotinamide riboside)

Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside PO daily for 6 weeks.

Other: Exercise Intervention
Complete home exercise

Dietary Supplement: Nicotinamide Riboside
Given PO
Other Names:
  • Niagen
  • NR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of a nutrition and exercise program in childhood cancer survivors (CCS) [Up to 6 weeks]

      The current protocol will be considered feasible if: >= 50% of eligible patients that are approached for participation enroll onto the study, >= 70% of enrolled participants successfully complete all study assessments (i.e. physical function tests, blood draw, imaging, and questionnaires at baseline and 6 weeks, and Enrolled participants demonstrate >= 70% compliance with prescribed exercise and nicotinamide riboside. Feasibility measures 2 and 3 will be assessed for the entire group of 20 subjects as a whole.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • History of childhood cancer

    • History of prediabetes (HbA1c 5.7-6.4%)

    • In remission at time of enrollment

    • Time between completion of cancer-directed therapy and study entry: >= 6 months

    • At least 18 years of age at time of enrollment

    • Able to access online exercise program at home

    • Ability to tolerate the prescribed resistance exercise program

    • English-speaking

    • Able to understand and sign the study specific informed consent form (ICF)

    Exclusion Criteria:

    • Taking a nicotinamide adenine dinucleotide (NAD)+ precursor in the two weeks prior to enrollment

    • Currently taking medication for hyperglycemia or diabetes

    • Females who are pregnant or planning to become pregnant

    • Currently recovering from an injury

    • Contraindication to magnetic resonance imaging (MRI)

    • Pacemaker

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Rusha Bhandari, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT05023993
    Other Study ID Numbers:
    • 20676
    • NCI-2021-02807
    • 20676
    • P30CA033572
    First Posted:
    Aug 27, 2021
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Insulin Resistance
    Prediabetic State
    Glucose Intolerance
    Niacinamide
    Niacin
    Nicotinic Acids

    Study Results

    No Results Posted as of Jul 5, 2022