RayGel-An Alternative for Skin Care During External Beam Radiation

August 27, 2013 updated by: Nathalie Johnson

Prospective Blinded Randomized Study; RayGel Versus Placebo-an Alternative for Skin Care During External Beam Radiation.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RayGel versus Placebo- An Alternative for Skin Care during External Beam Radiation Therapy

RayGel is a formulation of reduced glutathione and anthocyanins extracts from various blue/purple flowering plants. Glutathione has been studied in a variety of ways in conjunction with therapies directed at cancer. It is a functional molecule, which plays a significant role in maintenance of normal cellular metabolism and regulation. Reduced glutathione plays an essential role in DNA synthesis and repair, as well as leukotriene and prostaglandin metabolism. Studies have looked at using glutathione to reduce the complication of chemotherapy such as bone pain with Taxol, and urinary effects with cyclophosphamide, and neurotoxicity with cisplatin. It has shown efficacy in these arenas.

External beam radiation is a standard part of breast conservation treatment. It reduces rates of loco regional recurrence significantly. Skin reaction of varying degrees occurs in everyone under going treatment. Occasionally, it can be so severe that the treatment schedule must be altered to allow healing. We would like to study the effect that topical RayGel may have on reducing the reaction of skin during external beam radiation therapy of the breast.

Ineligibility criteria:

  1. Post mastectomy
  2. Previous irradiation of the same breast
  3. Pregnancy
  4. Younger than 18 years of age

Contraindication:

1.Hypersensitivity

Study Design:

Prospective blinded randomized study. Enroll 150 patients.

Group A - RayGel topical cream is applied in a thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.

Group B - Placebo topical cream is applied in a thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.

In addition, patients with bright erythema reaction will use skin products at the discretion of the radiation oncologist.

Patients would be consented prior to start of therapy. Digital photos of the radiation area would be taken at start, ~ 5 weeks and evaluated by the radiation oncologist using the 0-6 Skin Reaction Scale. (0-no changes to 6-ulceration, hemorrhage or necrosis).

Weekly skin assessments and documentation of changes would be performed by the radiation oncology nurse and radiation oncologist, using the, 0-6 Skin Reaction Scale. Also weekly assessment of patient comfort, using Legacy's patient subjective pain rating, (0 no pain to 10 severe pain). Patients will keep track of their own pain and the time of application of the study gel. They will do this daily and write it on the calendar provided to them. A 5 question survey related to their comfort will be completed by the study nurse at the last visit. Outcomes would be measured by degree of skin reaction, discomfort, and cosmetic outcome. Breaks in treatment schedule, secondary to skin changes would be recorded.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97210
        • Legacy Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Start of radiation therapy until completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thomas Johnson, MD, Legacy Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (Estimate)

December 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • NW-05TJohn-01
  • LHS Foundation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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