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OpenTrials
Completed

NCT Number: NCT01980719

Molecular Determinants of Persistent Cancer Related Fatigue

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: MDOF

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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