Clinical trial · Observational
Relationship of Mitochondrial Enzymes With Cancer Related Fatigue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Project Study: Pilot Human Study Specific Aims: 1. describe levels of mitochondrial respiratory enzymes 2. examine relationships between levels of mitochondrial enzymes, fatigue, and health-related quality of life; and 3. compare levels of mitochondrial enzymes in men with a clinically-significant change in fatigue from those with no change in fatigue. Significance of Study: Cancer related fatigue is a common side effect of cancer. Cancer related fatigue is poorly understood. Many different biological mechanisms have been theorized, including mitochondrial dysfunction. Self-reported descriptions of reduced energy and muscle weakness lend support for a possible relationship of cancer related fatigue to mitochondrial dysfunction. Main Research Variables: Mitochondrial Enzymes, Cancer related fatigue, and health related quality of life Design: Descriptive, longitudinal study Sample/Setting: Men with non-metastatic prostate-cancer who are scheduled to receive radiation therapy Methods: Questionnaires, mouth swabs and blood will be collected at four study visits: prior to treatment, midpoint of treatment, completion of treatment and within 90 days of finishing treatment. Four mouth swabs will be collected per participant at each study visit. Implications for Practice: Understanding the role of mitochondrial enzymes in cancer related fatigue has major clinical implications in the development of targeted interventions and in providing specific knowledge for patients and their families to make informed treatment decisions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| There is no intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Men with prostate cancer
- description
- men over 18 years of age diagnosed with prostate cancer receiving external beam radiation
- interventionNames
- Other: There is no intervention
Primary outcomes (1)
- measure
- Functional Assessment of Cancer Therapy-Prostate (FACT-P)
- timeFrame
- up to 180 days after completion of radiation
- description
- The FACT-P is a 39 item scale with a range of 0-140. Higher scores mean higher health related quality of life
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: diagnosis of prostate cancer, non metastatic, over 18 years of age, scheduled to receive external beam radiation, - Exclusion Criteria: have any inflammatory or infectious condition such as rheumatoid arthritis, lupus, or cirrhosis; an infectious disease such as HIV, tuberculosis, or hepatitis; have other types of cancer; had a major psychiatric disorder or alcohol or drug abuse within the past 5 years; (d) are receiving or scheduled to receive chemotherapy; or are on a prescribed anti-inflammatory regimen such as steroids, non-steroidal anti-inflammatories, or tranquilizers. \-
References
Publications (0)
Data not yet available