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RayGel-An Alternative for Skin Care During External Beam Radiation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System
ClinicalTrials.gov Identifier:
NCT00266331
First received: December 14, 2005
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

This study is for the patient with breast cancer. To take part in this study, external beam radiation therapy needs to be part of the treatment plan. Reduced glutathione, an ingredient of RayGel™, has been helpful in decreasing some radiation therapy side effects to the skin.

Reduced glutathione plays a vital role in both making DNA and cell repair. This study will measure if RayGel decreases skin reaction in breast cancer patients treated with external beam radiation therapy.


Condition Intervention Phase
Breast Cancer
Drug: Reduced glutathione
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prospective Blinded Randomized Study; RayGel Versus Placebo-an Alternative for Skin Care During External Beam Radiation.

Resource links provided by NLM:


Further study details as provided by Legacy Health System:

Primary Outcome Measures:
  • Reduction in skin damage [ Time Frame: Start of radiation therapy until completion ] [ Designated as safety issue: No ]
    Skin reaction scale along with evaluation by radiation oncologist at weekly intervals from start of radiation therapy until completion of radiation.


Enrollment: 150
Study Start Date: October 2004
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A, RayGel Topical Cream
RayGel Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.
Drug: Reduced glutathione
Placebo Comparator: Arm B Placebo Topical Cream
Placebo Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Breast Cancer

  • Radiation

Exclusion Criteria:

  1. Post Mastectomy
  2. Previous irradiation of the same breast
  3. Pregnacy
  4. Younger than 18 years of age
  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: NCT00266331

Locations
United States, Oregon
Legacy Health System
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Nathalie Johnson
Investigators
Principal Investigator: Thomas Johnson, MD Legacy Health System
  More Information

Additional Information:
Publications:
Responsible Party: Nathalie Johnson, Principal investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT00266331     History of Changes
Other Study ID Numbers: NW-05TJohn-01, LHS Foundation
Study First Received: December 14, 2005
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Health System:
Breast cancer
Radiation skin protection

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014