Breast CancerNCT00894712
Topical Application of Sulforaphane-containing Broccoli Sprout Extracts on Radiation Dermatitis
An observational study of Breast Cancer and Dermatitis, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The investigators plan to investigate the protective effects of topical sulforaphane-containing broccoli-sprout extracts (BSE) on radiation-induced dermatitis in women undergoing external-beam radiation therapy for breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Dermatitis
- What is being tested?
- Sulforaphane-containing broccoli sprout extracts (active agent)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2009to 15 Nov 2012
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer
Who may be able to join
- Must have pathologically confirmed invasive adenocarcinoma or ductal carcinoma in situ of the breast.
- Patients must have undergone segmental mastectomy (i.e., lumpectomy).
- Patients must not have received prior radiation therapy to the breast.
- Patients must not have active local-regional disease prior to registration.
- Patients must not be pregnant because of the potential for fetal harm as a result of radiation treatment. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. They will also be counseled on the importance of avoiding pregnancy and hormonal contraception while undergoing radiation therapy.
- Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
- All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
Who cannot join
- Visible skin pathology, excessive freckles, or skin blemishes in the test area.
- History of skin disease or hypersensitivity and repeated contact allergies.
- Sarcoma or squamous cell histology.
- Metastatic disease to the breast.
- Current tobacco use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Application of Sulforaphane- Containing Broccoli Sprout Extracts on Radiation Dermatitis During External-beam Radiation Therapy for Breast Cancer
The investigators plan to investigate the protective effects of topical sulforaphane-containing broccoli-sprout extracts (BSE) on radiation-induced dermatitis in women undergoing external-beam radiation therapy for breast cancer. Topical sulforaphane induces phase 2 enzymes that are protective against oxidants, electrophiles, and inflammation (Talalay and Fahey, 2001) - all of which are generated by both ultraviolet and ionizing radiation. Previous work from the investigators' group demonstrated that sulforaphane treatment protects against ultraviolet radiation-induced erythema of human skin (IRB protocol NA_00004897; Talalay et al. 2007). This investigation will extend the investigators' previous work by employing ionizing rather than ultraviolet radiation.
The investigators propose a two part sequential protocol (Study A and Study B). Both studies will involve women with breast cancer who have undergone lumpectomy and are scheduled for adjuvant external beam radiation treatment. In study A, the investigators will validate their technique for measurement of skin erythema using a device called a chromometer; no active agent will be applied (up to 6 women). Study B will follow completion of Study A. Study B will involve the application of broccoli sprout extracts (BSE) or vehicle alone to determine if sulforaphane can reduce radiation-induced erythema (27 women). Four adjacent, 1.5-cm diameter areas-of-interest on the affected breast will be located by means of an adhesive vinyl template which can be accurately and repeatedly placed at the same position. Two of the four areas will be treated with BSE (active agent) and two with vehicle (inactive control). BSE will be applied on three days weekly throughout the 5-week period of whole breast radiation. Erythema will be noninvasively quantified by measuring the red-reflectance of the skin with a chromometer up to three times weekly throughout treatment. A total of 33 patients are to be enrolled.
The investigators' objective is to determine and quantify the effect of topical BSE on radiation-induced skin erythema. This study will employ standard, clinically-accepted radiation doses and techniques that are safe and well tolerated. The safety and tolerability of both oral and topical broccoli sprout preparations is well established; no safety concerns have been noted. (Shapiro et al. 2006; Dinkova-Kostova et al. 2007).
- Conditions
- Breast Cancer, Dermatitis
- Being tested
- Sulforaphane-containing broccoli sprout extracts (active agent), Vehicle (inactive control)
- Keywords
- Radiation Therapy
- Medical subject headings
- Breast Neoplasms, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulforaphane-containing broccoli sprout extracts (active agent)Other
Topical application, prepared with acetone, 280 nml daily, 3 times a week.
Vehicle (inactive control)Device
Subjects will have measurements of skin erythema using a device called a chromometer
What is being measured
The primary outcome is the main question the study is designed to answer.
Variance of the skin erythema measurements due to non-radiation effects.
Measured: Week 0 and Week 1 of radiation treatment
Absolute change in red reflectance of the skin.
Measured: before and after radiation
Secondary outcomes (1)
Clinical grade of dermatitis (per NCI CTCAE v3.0 guidelines) for each region.
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study start15 Apr 2009
- Primary completion15 Nov 2012
- Study completion15 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Zellars, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894712
- Sponsor's protocol ID
- J-0838
- Other IDs
- NA_00018779
- Status last verified
- May 2019
- First submitted
- 5 May 2009
- Last updated
- 7 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Application of Sulforaphane- Containing Broccoli Sprout Extracts on Radiation Dermatitis During External-beam Radiation Therapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT00894712
- Acronym / sponsor ID
- J-0838
- Conditions
- Breast Cancer, Dermatitis
- Keywords
- Radiation Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 15 Apr 2009 (actual)
- Primary completion
- 15 Nov 2012 (actual)
- Study completion
- 15 Nov 2012 (actual)
- First posted
- 7 May 2009 (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.
The investigators plan to investigate the protective effects of topical sulforaphane-containing broccoli-sprout extracts (BSE) on radiation-induced dermatitis in women undergoing external-beam radiation therapy for breast cancer. Topical sulforaphane induces phase 2 enzymes that are protective against oxidants, electrophiles, and inflammation (Talalay and Fahey, 2001) - all of which are generated by both ultraviolet and ionizing radiation. Previous work from the investigators' group demonstrated that sulforaphane treatment protects against ultraviolet radiation-induced erythema of human skin (IRB protocol NA_00004897; Talalay et al. 2007). This investigation will extend the investigators' previous work by employing ionizing rather than ultraviolet radiation.
The investigators propose a two part sequential protocol (Study A and Study B). Both studies will involve women with breast cancer who have undergone lumpectomy and are scheduled for adjuvant external beam radiation treatment. In study A, the investigators will validate their technique for measurement of skin erythema using a device called a chromometer; no active agent will be applied (up to 6 women). Study B will follow completion of Study A. Study B will involve the application of broccoli sprout extracts (BSE) or vehicle alone to determine if sulforaphane can reduce radiation-induced erythema (27 women). Four adjacent, 1.5-cm diameter areas-of-interest on the affected breast will be located by means of an adhesive vinyl template which can be accurately and repeatedly placed at the same position. Two of the four areas will be treated with BSE (active agent) and two with vehicle (inactive control). BSE will be applied on three days weekly throughout the 5-week period of whole breast radiation. Erythema will be noninvasively quantified by measuring the red-reflectance of the skin with a chromometer up to three times weekly throughout treatment. A total of 33 patients are to be enrolled.
The investigators' objective is to determine and quantify the effect of topical BSE on radiation-induced skin erythema. This study will employ standard, clinically-accepted radiation doses and techniques that are safe and well tolerated. The safety and tolerability of both oral and topical broccoli sprout preparations is well established; no safety concerns have been noted. (Shapiro et al. 2006; Dinkova-Kostova et al. 2007).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer
Key inclusion criteria (7 listed)
- Must have pathologically confirmed invasive adenocarcinoma or ductal carcinoma in situ of the breast.
- Patients must have undergone segmental mastectomy (i.e., lumpectomy).
- Patients must not have received prior radiation therapy to the breast.
- Patients must not have active local-regional disease prior to registration.
- Patients must not be pregnant because of the potential for fetal harm as a result of radiation treatment. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. They will also be counseled on the importance of avoiding pregnancy and hormonal contraception while undergoing radiation therapy.
Key exclusion criteria (5 listed)
- Visible skin pathology, excessive freckles, or skin blemishes in the test area.
- History of skin disease or hypersensitivity and repeated contact allergies.
- Sarcoma or squamous cell histology.
- Metastatic disease to the breast.
- Current tobacco use.
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 |
|---|---|---|
| Sulforaphane-containing broccoli sprout extracts (active agent)Topical application, prepared with acetone, 280 nml daily, 3 times a week. | Other | – |
| Vehicle (inactive control)Subjects will have measurements of skin erythema using a device called a chromometer | Device | – |
Primary outcome
Variance of the skin erythema measurements due to non-radiation effects.
Time frame: Week 0 and Week 1 of radiation treatment
Absolute change in red reflectance of the skin.
Time frame: before and after radiation
1 secondary outcome
Clinical grade of dermatitis (per NCI CTCAE v3.0 guidelines) for each region.
Time frame: weekly
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 7 May 2019.
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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.
Richard Zellars, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Dermatitis, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 7 inclusion and 5 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 7 May 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Variance of the skin erythema measurements due to non-radiation effects. (time frame: Week 0 and Week 1 of radiation treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2019.