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

Breast Cancer Clinical Trial

Official title:

Use of Nutritional Supplements and CAM (Complementary and Alternative Medicine) by Prostate and Breast Cancer Patients Undergoing Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823549
• Other study ID #: OSU-0240
• Status: Completed
• Start date: December 11, 2002
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 31, 2023
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Prostate Cancer

Intervention

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 year
Primary	Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment.		Up to 1 year
Primary	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
Primary	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
Primary	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

External Links

•   Jamesline