Breast CancerPhase 2NCT00266331
RayGel-An Alternative for Skin Care During External Beam Radiation
A Phase 2 study testing Reduced glutathione in people with Breast Cancer, run by Nathalie Johnson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Reduced glutathione
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Breast Cancer
- Radiation
Who cannot join
- Post Mastectomy
- Previous irradiation of the same breast
- Pregnacy
- Younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Blinded Randomized Study; RayGel Versus Placebo-an Alternative for Skin Care During External Beam Radiation.
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.
Read the 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:
- Post mastectomy
- Previous irradiation of the same breast
- Pregnancy
- 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
- Breast Cancer
- Being tested
- Reduced glutathione
- Keywords
- Breast cancer, Radiation skin protection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced glutathioneDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A, RayGel Topical Cream | Active comparator | RayGel Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments. Receives: Drug: Reduced glutathione |
| Arm B Placebo Topical Cream | Placebo comparator | Placebo Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of radiation therapy until completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathalie Johnson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nathalie Johnson, Legacy Health System
- Investigators
- Thomas Johnson, MD, Principal investigator, Legacy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266331
- Sponsor's protocol ID
- NW-05TJohn-01
- Other IDs
- LHS Foundation
- Status last verified
- Aug 2013
- First submitted
- 14 Dec 2005
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15862509
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Blinded Randomized Study; RayGel Versus Placebo-an Alternative for Skin Care During External Beam Radiation.
- ClinicalTrials.gov ID
- NCT00266331
- Acronym / sponsor ID
- NW-05TJohn-01
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Radiation skin protection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nathalie JohnsonUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Post mastectomy
- Previous irradiation of the same breast
- Pregnancy
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, RayGel Topical Cream | Active comparator | Drug: Reduced glutathioneRayGel 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 comparator | –Placebo Topical Cream applied in thin layer to the area exposed to radiation 60-90 minutes prior to radiotherapy, standard skin care between treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Breast Cancer
- Radiation
Key exclusion criteria (4 listed)
- Post Mastectomy
- Previous irradiation of the same breast
- Pregnacy
- Younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced glutathione | Drug | Group A, RayGel Topical Cream |
Primary outcome
Reduction in skin damage
Time frame: Start of radiation therapy until completion
Skin reaction scale along with evaluation by radiation oncologist at weekly intervals from start of radiation therapy until completion of radiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Results publication: PubMed 15862509Miko 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 InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Johnson, MD principal investigator
Legacy Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reduced glutathione in people with Breast Cancer, run by Nathalie Johnson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in skin damage (time frame: Start of radiation therapy until completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00266331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.