Trial record 8 of 402 for:    (complementary OR alternative) medicine AND (woman OR women OR female)

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01823549
First received: March 28, 2013
Last updated: April 2, 2013
Last verified: March 2013
  Purpose

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 Intervention
Prostate Cancer Patients
Breast Cancer Patients
Other: questionnaire administration

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Determine if patients change their patterns of CAM use prior to, during, or after radiation treatment. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Assess radiation therapy toxicity using standardized criteria from the Oncology Nursing Society and determine if there is a correlation between CAM use and quality of life. [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • To determine predictive factors for CAM and nutritional supplement use, such as age, race, income, education, marital status, or tobacco/alcohol use. Study Plan: [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: questionnaire administration
    Ancillary studies
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823549

Locations
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Steven Clinton, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01823549     History of Changes
Other Study ID Numbers: OSU-0240
Study First Received: March 28, 2013
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Ohio State University Comprehensive Cancer Center:
CAM
Alternative Medicine

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014