Molecular Determinants of Persistent Cancer Related Fatigue (MDOF)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Fatigue; Poor Sleep Quality

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female breast cancer survivors

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy, Age-Matched
Fatigued
Not Fatigued

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers.	6 weeks

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 29, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: HUM00038766