Know Cancer

or
forgot password

Effect of Topical Application of Sulforaphane- Containing Broccoli Sprout Extracts on Radiation Dermatitis During External-beam Radiation Therapy for Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Dermatitis

Thank you

Trial Information

Effect of Topical Application of Sulforaphane- Containing Broccoli Sprout Extracts on Radiation Dermatitis During External-beam Radiation Therapy for Breast Cancer


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Variance of the skin erythema measurements due to non-radiation effects.

Outcome Time Frame:

Week 0 and Week 1 of radiation treatment

Safety Issue:

No

Principal Investigator

Richard Zellars, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

J-0838

NCT ID:

NCT00894712

Start Date:

April 2009

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • Dermatitis
  • Radiation Therapy
  • Breast Neoplasms
  • Dermatitis
  • Radiodermatitis

Name

Location

Johns Hopkins University Baltimore, Maryland  21205