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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00481884
First received: May 31, 2007
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Radiation Dermatitis
Other: RadiaPlexRx Gel
Other: Aquaphor Gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: May 2007
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RadiaPlexRx Gel
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.
Active Comparator: Aquaphor Gel
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:

  1. Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted)
  2. Patient has breast conserving surgery (lumpectomy) for breast cancer with negative surgical margin
  3. Stage Tis,0-3 N0-2 M0
  4. 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
  5. 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
  6. Patient wears bras with cup size larger than A
  7. Patient signs informed consent

Exclusion Criteria:

  1. Breast cancer treatment with mastectomy
  2. Stage T4 breast cancer
  3. Patient will require the use of tissue-equivalent bolus during radiation treatment or double treatment of junctions of radiation treatment fields
  4. Patient will require treatment to the internal mammary chain lymph node bed using a separate radiation electron field
  5. Patient is planned for partial-breast irradiation or Mammo-site treatment.
  6. Patient has unhealed wound or rash in the radiation field
  7. Patient has allergy to RadiaPlexRx or aloe vera
  8. Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development
  9. Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Herceptin® [Trastuzumab])
  10. Planned accelerated fractionation.
  11. Planned radiation therapy to the bilateral breasts
  12. Planned breast irradiation in the prone position
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Thomas Buchholz, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00481884     History of Changes
Other Study ID Numbers: 2006-0827
Study First Received: May 31, 2007
Last Updated: January 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Radiation Dermatitis
RadiaPlexRx Gel
Aquaphor

Additional relevant MeSH terms:
Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014