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.

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.

  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
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014