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Trial · Interventional

CompletedPhase 2Registry data

RayGel-An Alternative for Skin Care During External Beam Radiation

NCTNCT00266331 (opens ClinicalTrials.gov in a new tab)Other idNW-05TJohn-01Other idLHS Foundation
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
150 participants (actual)
Sponsor
Nathalie Johnson · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Oct 2004
Primary completion
May 2011
Completion
May 2011
First posted
16 Dec 2005 (estimated)
Last update posted
28 Aug 2013 (estimated)
Conditions
Breast Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph 2

    RayGel-An Alternative for Skin Care During External Beam Radiation

    NCT00266331

    Oct 2004 to May 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Reduced glutathioneDrug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Reduction in skin damage

    Time frame · Start of radiation therapy until completion

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultMiko 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 15862509

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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