Relationship of Mitochondrial Enzymes With Cancer Related Fatigue

NCT ID: NCT02414971

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-01-14

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Men with prostate cancer

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

There is no intervention

Intervention Type: OTHER

There is no intervention

Interventions

There is no intervention

There is no intervention

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra L Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

OCR14952

Identifier Type: OTHER

Identifier Source: secondary_id

pending

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201500023-N

Identifier Type: -

Identifier Source: org_study_id