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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Reduction in skin damage

Outcome Description:

Skin reaction scale along with evaluation by radiation oncologist at weekly intervals from start of radiation therapy until completion of radiation.

Outcome Time Frame:

Start of radiation therapy until completion

Safety Issue:

No

Principal Investigator

Thomas Johnson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Legacy Health System

Authority:

United States: Institutional Review Board

Study ID:

NW-05TJohn-01

NCT ID:

NCT00266331

Start Date:

October 2004

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Radiation skin protection
  • Breast Neoplasms

Name

Location

Legacy Health SystemPortland, Oregon  97210