RayGel-An Alternative for Skin Care During External Beam Radiation
Prospective Blinded Randomized Study; RayGel Versus Placebo-an Alternative for Skin Care During External Beam Radiation.
2 other identifiers
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Oct 2004
Typical duration for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 14, 2005
CompletedFirst Posted
Study publicly available on registry
December 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedAugust 28, 2013
August 1, 2013
6.6 years
December 14, 2005
August 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in skin damage
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
Study Arms (2)
Group A, RayGel Topical Cream
ACTIVE COMPARATORRayGel Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.
Arm B Placebo Topical Cream
PLACEBO COMPARATORPlacebo Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments.
Interventions
Eligibility Criteria
You may qualify if:
- \. Breast Cancer
- Radiation
You may not qualify if:
- Post Mastectomy
- Previous irradiation of the same breast
- Pregnacy
- Younger than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nathalie Johnsonlead
Study Sites (1)
Legacy Health System
Portland, Oregon, 97210, United States
Related Publications (1)
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.
PMID: 15862509RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Johnson, MD
Legacy Health System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 14, 2005
First Posted
December 16, 2005
Study Start
October 1, 2004
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
August 28, 2013
Record last verified: 2013-08