Relationship of Mitochondrial Enzymes With Cancer Related Fatigue

NCT02414971 | Completed DMC

• 3 other identifiers: IRB201500023-NOCR14952pending
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

cancer related fatigue; prostate cancer; mitochondria

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Men with prostate cancer

men over 18 years of age diagnosed with prostate cancer receiving external beam radiation

Other: There is no intervention

Interventions

There is no intervention OTHER

There is no intervention

Men with prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men over 18 years of age diagnosed with prostate cancer

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Buccal swabs Whole blood

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Debra L Kelly, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 13, 2015
• Study Start: April 1, 2015
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (1)