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MDOF: Molecular Determinants of Persistent Cancer Related Fatigue

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT01980719
Collaborator
(none)
30
Enrollment
1
Location
56
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if inflammatory markers in blood as well as brain neurotransmitters (markers of in-brain activity and metabolism) are related to long-term or chronic fatigue.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Molecular Determinants of Persistent Cancer Related Fatigue
    Study Start Date :
    Jul 1, 2010
    Actual Primary Completion Date :
    Mar 1, 2015
    Actual Study Completion Date :
    Mar 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy, Age-Matched
    Fatigued
    Not Fatigued

    Outcome Measures

    Primary Outcome Measures

    1. Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity). [6 weeks]

    Secondary Outcome Measures

    1. Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers. [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    All Participants:
    • Women age 18 or older with no contraindication to magnetic resonance imaging(MRI);
    Fatigued BC Participants:

    • Have a diagnosis of breast cancer;

    • And have completed all cancer-related treatments (i.e., surgery, chemotherapy, radiotherapy, immunotherapy, etc.) except for hormonal therapy and or herceptin at least 12 weeks previously; and be apparently cancer-free.

    Age-Matched, Healthy Participants:

    • Generally healthy;

    • Matched in age ± 2.5 years to a Fatigued BC participant.

    • No prior history of any cancer except for basal cell or squamous cell tumors of the skin that have been surgically excised;

    • Have good sleep quality

    • Have no chronic pain

    • Have no chronic fatigue

    Exclusion Criteria:

    • Pregnant, wanting to become pregnant or lactating women ;

    • Diagnosed with anemia [defined as hemoglobin levels < 12 gm/dl] or receiving treatment for anemia ;

    • Diagnosed with any comorbidities likely to cause significant fatigue (i.e., moderate to severe heart failure)

    • Diagnosed with nutritional deficiencies;

    • Have a diagnosis of untreated hypo- or hyper-thyroidism

    • Have an initiation, a cessation or change of dose (up to three weeks prior to the study's start) of any chronic medications or dietary supplements or any planned change of chronic medications or dietary supplements during the study;

    • Have implanted (e.g., surgical clips or staples) metal objects.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48106

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    • Principal Investigator: Suzanna M Zick, ND, MPH, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suzanna Zick, Research Associate Professor, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT01980719
    Other Study ID Numbers:
    • HUM00038766
    First Posted:
    Nov 11, 2013
    Last Update Posted:
    Mar 26, 2015
    Last Verified:
    Nov 1, 2013
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    No Results Posted as of Mar 26, 2015