Prostate Cancer Clinical Trial
Official title:
Relationship of Mitochondrial Enzymes With Cancer Related Fatigue
Verified date | January 2020 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | January 14, 2019 |
Est. primary completion date | January 14, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. - |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Institute of Nursing Research (NINR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Assessment of Cancer Therapy-Prostate (FACT-P) | The FACT-P is a 39 item scale with a range of 0-140. Higher scores mean higher health related quality of life | up to 180 days after completion of radiation |
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