Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients
December 24, 2025 updated by: Steven Clinton, Ohio State University Comprehensive Cancer Center
Use of Nutritional Supplements and CAM (Complementary and Alternative Medicine) by Prostate and Breast Cancer Patients Undergoing Radiotherapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
109
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Men with clinically localized prostate cancer that have chosen external beam irradiation or brachytherapy or a combination for their treatment and women with localized breast cancer who are scheduled to begin external beam radiation therapy as a component of their primary or adjuvant therapy.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation therapy at The James Cancer Hospital and Solove Research Institute.
Nutrient supplements and alternative medication use is the primary focus of the assessment.
|
Up to 1 year
|
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Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment.
Time Frame: Up to 1 year
|
Up to 1 year
|
|
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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
|
Up to 1 year
|
|
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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
|
Up to 1 year
|
|
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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
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven Clinton, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2002
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
March 28, 2013
First Submitted That Met QC Criteria
April 2, 2013
First Posted (Estimated)
April 4, 2013
Study Record Updates
Last Update Posted (Estimated)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 24, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-0240
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.