Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients - Full Text View

Purpose

Primary Objective:

1. To determine if RadiaPlexRx Hydrogel can reduce the development of grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation when compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care.

Condition	Intervention	Phase
Radiation Dermatitis	Other: RadiaPlexRx Gel Other: Aquaphor Gel	Phase III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment, Efficacy Study

Official Title:	Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Determine if RadiaPlexRx Hydrogel can reduce the development of grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation when compared to a petroleum-based gel (Aquaphor) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	92
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental RadiaPlexRx Gel for application to one half of irradiated breast skin, determined by a randomization process.	Other: RadiaPlexRx Gel RadiaPlexRx Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply RadiaPlexRx gel topically 3 Times Daily to one half of the irradiated breast skin and the control, Aquaphor gel, to the other half of irradiated breast skin. This is determined through randomization process.
2: Active Comparator Aquaphor Gel for application to one half of irradiated breast skin, determined by a randomization process.	Other: Aquaphor Gel Aquaphor Gel: The treated breast is divided into two vertical halves during the simulation using skin marker (medial and lateral halves). Patients are given detailed instructions to apply Aquaphor gel topically 3 Times Daily to one half of the irradiated breast skin and the experimental, RadiaPlexRx gel, to the other half of irradiated breast skin. This is determined through randomization process.

Show Detailed Description

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
Patient has breast conserving surgery (lumpectomy) for breast cancer with negative surgical margin
Stage Tis,0-3 N0-2 M0
Patient will receive irradiation of whole breast. An additional field to treat the supraclavicular / axillary apex lymphatics is allowed, but a separate field to treat the internal mammary chain nodes is not allowed
The breast will receive radiation dose greater than or equal to 50 Gy, with or without a boost field to give additional dose to the tumor bed
Patient wears bras with cup size larger than A
Patient signs informed consent

Exclusion Criteria:

Breast cancer treatment with mastectomy
Stage T4 breast cancer
Patient will require the use of tissue-equivalent bolus during radiation treatment or double treatment of junctions of radiation treatment fields
Patient will require treatment to the internal mammary chain lymph node bed using a separate radiation electron field
Patient is planned for partial-breast irradiation or Mammosite treatment.
Patient has unhealed wound or rash in the radiation field
Patient has allergy to RadiaPlexRx or aloe vera
Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
Patient has plan for concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481884

Contacts


Contact: Tse-Kuan Yu, MD, PhD	713-794-4892

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Tse-Kuan Yu, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Tse-Kuan Yu, MD, PhD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T. M.D. Anderson Cancer Center ( Tse-Kuan Yu, MD/Asst. Professor )
Study ID Numbers:	2006-0827
First Received:	May 31, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00481884
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer

Radiation Dermatitis

RadiaPlexRx Gel

Aquaphor

Study placed in the following topic categories:

Skin Diseases

Wounds and Injuries

Disorders of Environmental Origin

Radiodermatitis

Breast Neoplasms

Radiation Injuries

Breast Diseases

Dermatitis

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00481884