Molecular Determinants of Persistent Cancer Related Fatigue

Pain Clinical Trial

— MDOF  

Official title:

Molecular Determinants of Persistent Cancer Related Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980719
• Other study ID #: HUM00038766
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: March 25, 2015
• Start date: July 2010
• Est. completion date: March 2015

Study information

• Verified date: November 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatigue
• Pain
• Poor Sleep Quality

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity).		6 weeks	No
Secondary	Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers.		6 weeks	No