Clinical trial NCT01823549: Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients
Official title: Use of Nutritional Supplements and CAM (Complementary and Alternative Medicine) by Prostate and Breast Cancer Patients Undergoing Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Breast Cancer
Keywords: CAM
Alternative Medicine
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-04-04
Enrollment: 109
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Quantitate the various types of CAM therapy utilized by men with prostate cancer and women with breast cancer who are currently undergoing radiation.
timeFrame: Up to 1 year
measure: Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment.
timeFrame: Up to 1 year
measure: Assess quality of life using validated instruments during radiation therapy and determine if there is a correlation between CAM use and quality of life.
timeFrame: Up to 1 year
measure: 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.
timeFrame: Up to 1 year
measure: To determine predictive factors for CAM and nutritional supplement use, such as age, race, income, education, marital status, or tobacco/alcohol use.
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Steven Clinton, MD
role: PRINCIPAL_INVESTIGATOR
References: