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

NCT01823549 | Completed

• 1 other identifier: OSU-0240
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Breast Cancer

Keywords

CAM; Alternative Medicine

Outcome Measures

Primary Outcomes (5)

• 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

• Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment.

  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.

  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.

  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.

  Up to 1 year

Interventions

questionnaire administration OTHER

Ancillary studies

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven Clinton, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 4, 2013
• Study Start: December 11, 2002
• Primary Completion: September 1, 2014
• Study Completion: December 31, 2024
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (1)