Prostate CancerNCT01823549
Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients
An observational study of Prostate Cancer and Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Breast Cancer
- What is being tested?
- questionnaire administration
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2002to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
- Conditions
- Prostate Cancer, Breast Cancer
- Being tested
- questionnaire administration
- Keywords
- CAM, Alternative Medicine
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Ancillary studies
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation.
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.
Measured: Up to 1 year
Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study start11 Dec 2002
- Primary completionSep 2014
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Steven Clinton, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823549
- Sponsor's protocol ID
- OSU-0240
- Status last verified
- Dec 2025
- First submitted
- 28 Mar 2013
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nutritional Supplements and CAM (Complementary and Alternative Medicine) by Prostate and Breast Cancer Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT01823549
- Acronym / sponsor ID
- OSU-0240
- Conditions
- Prostate Cancer, Breast Cancer
- Keywords
- CAM, Alternative Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 11 Dec 2002 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire administrationAncillary studies | Other | – |
Primary outcome
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
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Clinton, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.