This trial is active, not recruiting.

Conditions prostate cancer, breast cancer
Treatment questionnaire administration
Sponsor Ohio State University Comprehensive Cancer Center
Collaborator National Center for Complementary and Integrative Health (NCCIH)
Start date October 2011
End date September 2014
Trial size 120 participants
Trial identifier NCT01823549, OSU-0240


This study was a survey to determine the frequency of Complementary and Alternative Medicine (CAM) use in patients recently diagnosed with breast or prostate cancer who were starting radiation therapy. The survey was repeated at three time points to assess changes in CAM use over time.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation.
time frame: Up to 1 year
Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment.
time frame: Up to 1 year
Assess quality of life using validated instruments during radiation therapy and determine if there is a correlation between CAM use and quality of life.
time frame: Up to 1 year
Assess radiation therapy toxicity using standardized criteria from the Oncology Nursing Society and determine if there is a correlation between CAM use and measures of toxicity.
time frame: Up to 1 year
To determine predictive factors for CAM and nutritional supplement use, such as age, race, income, education, marital status, or tobacco/alcohol use.
time frame: Up to 1 year

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

Inclusion/Exclusions - Men that have histologically proven carcinoma of the prostate and have chosen some form of radiation therapy as their primary therapy for prostate cancer. - Women who are undergoing external beam radiation therapy to the breast as primary or adjuvant therapy are eligible. - All participants must be able to read and write. - Subjects with dementia and mental retardation that complicates completing the questionnaires will not be enrolled. - Subjects with known metastatic disease will be excluded. - There are no age restrictions for this study.

Additional Information

Official title Use of Nutritional Supplements and CAM (Complementary and Alternative Medicine) by Prostate and Breast Cancer Patients Undergoing Radiotherapy
Principal investigator Steven Clinton, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.