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

NCT00481884 | Completed Phase 3 DMC

• 1 other identifier: 2006-0827
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: 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.

Conditions

Radiation Dermatitis

Keywords

Breast Cancer; Radiation Dermatitis; RadiaPlexRx Gel; Aquaphor

Outcome Measures

Primary Outcomes (1)

• Number of Patients using RadiaPlexRx Hydrogel that developed grade 2 or higher radiation dermatitis in breast cancer from adjuvant radiation compared to a petroleum-based gel (Aquaphor) commonly used as best supportive care

  6 weeks

Study Arms (2)

RadiaPlexRx Gel

EXPERIMENTAL

RadiaPlexRx Gel for application to one half of irradiated breast skin, determined by a randomization process.

Other: RadiaPlexRx Gel

Aquaphor Gel

ACTIVE COMPARATOR

Aquaphor Gel for application to one half of irradiated breast skin, determined by a randomization process.

Other: Aquaphor Gel

Interventions

RadiaPlexRx Gel OTHER

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.

RadiaPlexRx Gel

Aquaphor Gel OTHER

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.

Aquaphor Gel

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 Mammo-site 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 will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Herceptin® \[Trastuzumab\])
• Planned accelerated fractionation.
• Planned radiation therapy to the bilateral breasts
• Planned breast irradiation in the prone position

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Thomas Buchholz, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 4, 2007
• Study Start: May 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 2, 2016

Record last verified: 2012-01

Locations

US (1)