RayGel-An Alternative for Skin Care During External Beam Radiation
NCT ID: NCT00266331
Last Updated: 2013-08-28
Study Results
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Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2004-10-31
2011-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Reduced glutathione
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.
No interventions assigned to this group
Interventions
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Reduced glutathione
Eligibility Criteria
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Inclusion Criteria
* Radiation
Exclusion Criteria
2. Previous irradiation of the same breast
3. Pregnacy
4. Younger than 18 years of age
18 Years
FEMALE
Yes
Sponsors
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Nathalie Johnson
OTHER
Responsible Party
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Nathalie Johnson
Principal investigator
Principal Investigators
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Thomas Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Legacy Health System
Locations
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Legacy Health System
Portland, Oregon, United States
Countries
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References
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Miko Enomoto T, Johnson T, Peterson N, Homer L, Walts D, Johnson N. Combination glutathione and anthocyanins as an alternative for skin care during external-beam radiation. Am J Surg. 2005 May;189(5):627-30; discussion 630-1. doi: 10.1016/j.amjsurg.2005.02.001.
Related Links
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Related Info
Other Identifiers
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LHS Foundation
Identifier Type: -
Identifier Source: secondary_id
NW-05TJohn-01
Identifier Type: -
Identifier Source: org_study_id