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Relationship of Mitochondrial Enzymes With Cancer Related Fatigue

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by University of Florida
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02414971
First received: April 8, 2015
Last updated: March 23, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Prostate Cancer Other: There is no intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship of Mitochondrial Enzymes With Cancer Related Fatigue

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: up to 90 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


Biospecimen Retention:   Samples Without DNA
Buccal swabs Whole blood

Estimated Enrollment: 25
Actual Study Start Date: April 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Men with prostate cancer
men over 18 years of age diagnosed with prostate cancer receiving external beam radiation
Other: There is no intervention
There is no intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men over 18 years of age diagnosed with prostate cancer
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02414971

Contacts
Contact: Debra L Kelly, Ph.D. 3522736390 dlynchkelly@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Debra L Kelly, Ph.D.    352-273-6390    dlynchkelly@ufl.edu   
Contact: Rebecca Beaulieu, B.S.N.    352-672-8158 ext 87818    SHMIR@shands.ufl.edu   
Sponsors and Collaborators
University of Florida
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Debra L Kelly, PhD University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02414971     History of Changes
Other Study ID Numbers: IRB201500023
Study First Received: April 8, 2015
Last Updated: March 23, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
cancer related fatigue
prostate cancer
mitochondria

Additional relevant MeSH terms:
Prostatic Neoplasms
Fatigue
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 22, 2017