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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01823549
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
120
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104
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Study Details

Study Description

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 Phase
  • Other: questionnaire administration

Study Design

Study Type:
Observational
Anticipated 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 :
Oct 1, 2011
Actual Primary Completion Date :
Sep 1, 2014
Anticipated Study Completion Date :
Jun 1, 2020

Outcome Measures

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. [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. [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. [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. [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. [Up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Locations

Site City State Country Postal Code
1 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

  • Principal Investigator: Steven Clinton, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01823549
Other Study ID Numbers:
  • OSU-0240
First Posted:
Apr 4, 2013
Last Update Posted:
Aug 30, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2019