NCT01143467 is a clinical trial in Cancer, sponsored by National Institute of Nursing Research (NINR).

Who is sponsoring NCT01143467?

NCT01143467 is sponsored by National Institute of Nursing Research (NINR).

What condition does NCT01143467 study?

NCT01143467 studies Cancer, Fatigue.

Is NCT01143467 still recruiting?

NCT01143467 is currently completed. Last updated 6 October 2017.

Last reviewed 2017-10-06 · How we verify

NCT01143467

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 6 October 2017

What this trial tests

trial in Cancer in 26 participants. Completed in 6 November 2015.

Timeline

24 May 2010

6 November 2015

Quick facts

Lead sponsor	National Institute of Nursing Research (NINR)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	26
Start date	24 May 2010
Estimated completion	6 November 2015
Sites	1 location across United States

Conditions studied

Cancer — all drugs for Cancer →
Fatigue — all drugs for Fatigue →

Sponsor

National Institute of Nursing Research (NINR)

Who can join

Adults 18 to 100, male only, with Cancer or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Differential expression of genes related to mitochondrial biogenesis and bioenergetics in fatigued prostate cancer men receiving external beam radiation therapy.
Hsiao CP, Wang D, Kaushal A, Chen MK, et al · · 2014 · cited 26× · PMID 24786901 · DOI 10.1016/j.jpainsymman.2014.03.010
Lower brain-derived neurotrophic factor levels associated with worsening fatigue in prostate cancer patients during repeated stress from radiation therapy.
Saligan LN, Lukkahatai N, Holder G, Walitt B, et al · · 2016 · cited 20× · PMID 25815565 · DOI 10.3109/15622975.2015.1012227
Altered Cd8+ T lymphocyte Response Triggered by Arginase 1: Implication for Fatigue Intensification during Localized Radiation Therapy in Prostate Cancer Patients.
Saligan LN, Lukkahatai N, Zhang ZJ, Cheung CW, et al · · 2018 · cited 7× · PMID 30364895 · DOI 10.4172/neuropsychiatry.1000454

Verify or expand the search:

Other recruiting trials for Cancer

Currently open trials in the same condition.

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Other National Institute of Nursing Research (NINR) trials

Trials by the same sponsor.

NCT04141696 — A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue · Phase 1, PHASE2 · completed
NCT04883359 — Immersive VR Environments to Induce and Evaluate Cognitive Fatigability · terminated
NCT03998358 — Characterization of Fatigue in Military Personnel With Traumatic Brain Injuries · withdrawn
NCT03394040 — Point-of-Use Pathogen Identification Tool for Diarrhea · terminated
NCT02931474 — Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and · Phase 2 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01143467 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Nursing Research (NINR)
Last refreshed: 6 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01143467.

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