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.