We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

RayGel-An Alternative for Skin Care During External Beam Radiation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266331
First Posted: December 16, 2005
Last Update Posted: August 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nathalie Johnson, Legacy Health System
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Nathalie Johnson, Legacy Health System:

Primary Outcome Measures:
  • Reduction in skin damage [ Time Frame: Start of radiation therapy until completion ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 14, 2005
First Posted: December 16, 2005
Last Update Posted: August 28, 2013
Last Verified: August 2013

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