FatigueMDOFNCT01980719
Molecular Determinants of Persistent Cancer Related Fatigue
An observational study of Fatigue and Pain, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Pain, Poor Sleep Quality
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female breast cancer survivors
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy, Age-Matched | Not described | |
| Fatigued | Not described | |
| Not Fatigued | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity).
Measured: 6 weeks
Secondary outcomes (1)
Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJul 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanna Zick, University of Michigan
- Investigators
- Suzanna M Zick, ND, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980719
- Sponsor's protocol ID
- HUM00038766
- Acronym
- MDOF
- Status last verified
- Nov 2013
- First submitted
- 29 Oct 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Determinants of Persistent Cancer Related Fatigue
- ClinicalTrials.gov ID
- NCT01980719
- Acronym / sponsor ID
- MDOF / HUM00038766
- Conditions
- Fatigue, Pain, Poor Sleep Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy, Age-Matched | – | – |
| Fatigued | – | – |
| Not Fatigued | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer survivors
Key inclusion criteria (12 listed)
- Women age 18 or older with no contraindication to magnetic resonance imaging(MRI);
- 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.
- Generally healthy;
- Matched in age ± 2.5 years to a Fatigued BC participant.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity).
Time frame: 6 weeks
1 secondary outcome
Compare fatigue, pain, and sleep quality with peripheral immune markers, CRP, and brain markers.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanna M Zick, ND, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare peripheral immune markers (cytokines), C-reactive protein levels and brain neurotransmitters (glutamate, GABA, myoinositol, and resting state intrinsic connectivity). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.