Relationship of Mitochondrial Enzymes With Cancer Related Fatigue

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.

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.

-