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Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01823549
Recruitment Status : Unknown
Verified August 2019 by Steven Clinton, Ohio State University Comprehensive Cancer Center.
Recruitment status was:  Active, not recruiting
First Posted : April 4, 2013
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Prostate Cancer Breast Cancer Other: questionnaire administration

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Nutritional Supplements and CAM (Complementary and Alternative Medicine) by Prostate and Breast Cancer Patients Undergoing Radiotherapy
Study Start Date : October 2011
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : June 2020

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Groups and Cohorts
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Intervention Details:
  • Other: questionnaire administration
    Ancillary studies

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment. [ Time Frame: Up to 1 year ]
  3. 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 ]
  4. 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 ]
  5. 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
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823549


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Steven Clinton, MD Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:

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Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01823549    
Other Study ID Numbers: OSU-0240
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Keywords provided by Steven Clinton, Ohio State University Comprehensive Cancer Center:
CAM
Alternative Medicine
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases