Molecular Determinants of Persistent Cancer Related Fatigue

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01980719

Acronym

MDOF

Enrollment

Registered

2013-11-11

Start date

2010-07-31

Completion date

2015-03-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Pain, Poor Sleep Quality

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

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

Countries

United States

Outcome results