Radiation DermatitisPhase 3NCT00481884
Comparing RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients
A Phase 3 study testing RadiaPlexRx Gel and Aquaphor Gel in people with Radiation Dermatitis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- RadiaPlexRx Gel and Aquaphor Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiation Dermatitis
- Being tested
- RadiaPlexRx Gel, Aquaphor Gel
- Keywords
- Breast Cancer, Radiation Dermatitis, RadiaPlexRx Gel, Aquaphor
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiaPlexRx GelOther
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.
Aquaphor GelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RadiaPlexRx Gel | Experimental | RadiaPlexRx Gel for application to one half of irradiated breast skin, determined by a randomization process. Receives: Other: RadiaPlexRx Gel |
| Aquaphor Gel | Active comparator | Aquaphor Gel for application to one half of irradiated breast skin, determined by a randomization process. Receives: Other: Aquaphor Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Buchholz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481884
- Sponsor's protocol ID
- 2006-0827
- Status last verified
- Jan 2012
- First submitted
- 31 May 2007
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial to Compare RadiaPlexRx Hydrogel and Standard-of-Care for Radiation Dermatitis in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00481884
- Acronym / sponsor ID
- 2006-0827
- Conditions
- Radiation Dermatitis
- Keywords
- Breast Cancer, Radiation Dermatitis, RadiaPlexRx Gel, Aquaphor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RadiaPlexRx Gel | Experimental | Other: RadiaPlexRx GelRadiaPlexRx Gel for application to one half of irradiated breast skin, determined by a randomization process. |
| Aquaphor Gel | Active comparator | Other: Aquaphor GelAquaphor Gel for application to one half of irradiated breast skin, determined by a randomization process. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiaPlexRx GelRadiaPlexRx 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. | Other | RadiaPlexRx Gel |
| Aquaphor GelAquaphor 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. | Other | Aquaphor Gel |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Buchholz, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RadiaPlexRx Gel and Aquaphor Gel in people with Radiation Dermatitis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.