CompletedNot Applicable

Relationship Between Mitochondrial Dysfunction and Fatique in Cancer Patients Following External Beam Radiation Therapy

United States26 participantsStarted 2010-05-24

Plain-language summary

Background: \- Fatigue is a very common early and late side effect of cancer treatment, including radiation therapy. The cause of fatigue is poorly understood, making it hard to diagnose and treat. More research is necessary to understand why patients receiving cancer treatment experience fatigue. Changes in mitochondria, parts of body cells that help provide energy to the cell, may contribute to fatigue. Researchers are interested in looking at blood chemicals and mitochondrial genes of cancer patients to study those associated with fatigue. Objectives: \- To study the relationship between fatigue and the effects of cancer treatment. Eligibility: * Men at least 18 years of age who have been diagnosed with localized prostate cancer and are scheduled to receive external beam radiation therapy. * Participants on study 09-NR-0088, Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving External Beam Radiation Therapy, are also eligible. Design: * This study requires three outpatient visits to the NIH Clinical Center. * Participants will be seen before they start radiation treatment, at the middle of treatment, and at the end of treatment. Each visit will take less than 30 minutes to complete. * Participants will complete questionnaires that ask about fatigue and depression. * Participants will provide blood samples for research testing and potential HIV testing. * No treatment will be provided as part of this protocol.

Who can participate

Age range

18 Years – 100 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Clinically localized prostate cancer;
. Scheduled to receive EBRT either by 3D conformal or IMRT techniques that is not anticipated to change during the course of the study, with or without Androgen Deprivation Therapy (ADT);
. Able to provide written informed consent;
. Men greater than or equal to 18 years of age;
. Have enrolled in the study of molecular-genetic correlates of fatigue in cancer patients receiving localized radiation therapy (09-NR-0088).

Exclusion criteria

. Systemic infections (e.g., human immunodeficiency virus \[HIV\], active hepatitis);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT01143467

SponsorNational Institute of Nursing Research (NINR)

Sponsor typeNIH

Study typeOBSERVATIONAL

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