Relationship of Mitochondrial Enzymes With Cancer Related Fatigue

Completed

• Conditions: Prostate Cancer
• Interventions: Other: There is no intervention

• Registration Number: NCT02414971
• Lead Sponsor: University of Florida

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.

Detailed Description

Project Narrative

Purpose and Specific Aims The primary purpose of this pilot study is to explore the relationship between mitochondria and fatigue in men diagnosed prostate cancer. The specific aims are to: (a) describe levels of mitochondrial enzymes, (b) examine relationships between levels of mitochondrial enzymes, fatigue, and health-related quality of life (HRQOL); and (c) compare levels of mitochondrial enzymes in men with and without fatigue.

Methods Design The proposed study will use a descriptive, longitudinal design to describe levels of mitochondrial enzymes Sample and Setting Men with prostate cancer who are scheduled to receive radiation at the University of Florida Health Cancer Center will be eligible for study participation. Men will be enrolled if they: (a) have prostate cancer (b) are scheduled to receive radiation and (c) are at least 18 years of age. Patients will be excluded if they: (a) have any inflammatory or infectious condition such as rheumatoid arthritis, lupus, or cirrhosis; an infectious disease such as HIV, tuberculosis, or hepatitis; (b) have other types of cancer; (c) had a major psychiatric disorder or alcohol or drug abuse within the past 5 years; (d) are receiving or scheduled to receive chemotherapy; or (e) are taking steroids, non-steroidal anti-inflammatories, or tranquilizers.

Experimental Variables:

The primary purpose of this study is to describe levels of mitochondrial enzymes, Cancer related fatigue and health related quality of life.

All mouth swab samples collected will be coded and stored in a secured freezer. The frozen buccal swab samples will be batch shipped to the National Institute of Nursing Research and then processed and shipped to St. Christopher's Hospital for Children of Philadelphia for analyses.

Data Collection Schedule Study time points. Data will be collected at four study visits: baseline, midpoint of treatment, completion of treatment and within 90 days after treatment. Four buccal swabs will be collected per participant at each study visit using the Epicentre Catch-All Sample Collection Swabs-Soft Pack.

Study Procedures. The patients included in this study will be consented and enrolled into an Institutional Review Board-approved protocol for men with prostate cancer who are scheduled to receive radiation treatment. Biologic (buccal swabs) and questionnaire (Functional Assessment of Cancer Therapy-Prostate) data will be collected at each of four study visits. Each study visit will be arranged to coincide with scheduled clinic visits to decrease patient burden.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-10
• Study First Posted: 2015-04-13
• Primary Completion: 2019-01-14
• Study Completion: 2019-01-14
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

diagnosis of prostate cancer, non metastatic, over 18 years of age, scheduled to receive external beam radiation, -

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men with prostate cancer	There is no intervention	men over 18 years of age diagnosed with prostate cancer receiving external beam radiation

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy-Prostate (FACT-P)	up to 180 days after completion of radiation	The FACT-P is a 39 item scale with a range of 0-140. Higher scores mean higher health related quality of life

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States