Molecular Determinants of Persistent Cancer Related Fatigue

NCT ID: NCT01980719

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-03-31

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.

Conditions

Fatigue; Pain; Poor Sleep Quality

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy, Age-Matched

No interventions assigned to this group

Fatigued

No interventions assigned to this group

Not Fatigued

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Suzanna Zick

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanna M Zick, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00038766

Identifier Type: -

Identifier Source: org_study_id