Molecular Determinants of Persistent Cancer Related Fatigue

NCT01980719 | Completed

• 1 other identifier: HUM00038766
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (1)

• Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers.

  6 weeks

Study Arms (3)

Healthy, Age-Matched

Fatigued

Not Fatigued

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female breast cancer survivors

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

MeSH Terms

Conditions

Fatigue; Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Suzanna M Zick, ND, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 11, 2013
• Study Start: July 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 26, 2015

Record last verified: 2013-11

Locations

US (1)