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

April 29, 2016 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Study Gels:

RadiaPlexRx (requires a prescription) and Aquaphor (over-the-counter) are both gels that are designed to treat irradiated (received radiation) breast skin.

These 2 gels contain different ingredients that may make one gel better than the other to treat irradiated breast skin. RadiaPlexRx contains hyaluronic acid (an ingredient found naturally in skin), aloe vera, and other ingredients that help the skin heal. Aquaphor is made of mostly petroleum that helps protect the skin.

Application of Study Gels:

If you decide to participate in this study, the following steps will be taken:

  • You will be given detailed instructions on how to apply both of the gels. You should not apply other gels or lotions on the areas of skin where you will be instructed to apply the study gels, unless you are instructed to do so by the treating doctor.
  • You will receive a supply of both gels (in tubes) with enough to last for the length of your treatment. You will know which gel is which, but each gel will be labeled with "outer" or "inner" so that you will know which gel to use on which side. You should not tell your treating doctor which side of the breast skin is being treated with which gel so that a fair comparison of the gels can be made.
  • You will apply 1 gel to the outer side of the irradiated breast skin and the other gel to the inner side of the irradiated breast skin.
  • If you experience any kind of allergic reaction (such as a rash) to the study gels, you should notify the study doctor or study staff immediately.

Schedule for Study Gels:

You will need to follow the schedule for applying the gels as follows:

  • You will need to apply both gels starting 1 day before the start of radiation treatments.
  • You will then need to apply both gels for 6 weeks during radiation treatment.
  • During the study period (1 day before the start of radiation treatment, during 6 weeks of radiation treatment), you will need to apply both gels 3 times (in the morning, afternoon, and evening just before going to sleep) each day at home.
  • During the days that you receive radiation treatment, you will be asked to apply the gels immediately after you receive your radiation treatment. This will count as 1 of the 3 daily gel applications.

Clinic Visits:

You will have the following tests done during your clinic visits:

  • Three (3) sets of photos of your breast skin will be taken (before radiation starts and during Weeks 3 and 6 of radiation therapy treatment).
  • During Weeks 1 through 6, you will go to the clinic to have your skin checked by your treating physician to learn the effects of each gel on your symptoms. .
  • You will need to return any empty tubes of study gel so that new tubes can be given if you will need more.

Length of Study:

If the treating doctor sees that the irradiated breast skin reacts poorly (does not improve or gets worse) or you experience any intolerable side effects, you will be taken off this study. Otherwise, the total time on this study is about 6 weeks.

End-of-Study:

-During your last week of radiation therapy treatment you will be asked to fill out a questionnaire about how you felt about each gel.

This is an investigational study. RadiaPlexRx and Aquaphor are both FDA approved and commercially available. Up to 92 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Thomas Buchholz, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

May 31, 2007

First Posted (ESTIMATE)

June 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0827

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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