Breast CancerNCT02165605
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
A study testing HylaCare in people with Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HylaCare
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age 18 or older
- Diagnosis of breast cancer
- Intact breast (not surgically absent)
- Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)
- Ability to understand and comply with the requirements of this study
- Ability to give Informed Consent
- For sexually active females, patient agrees to use acceptable method of birth control
Who cannot join
- Women who are pregnant or lactating
- Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
- Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
- Planned relocation which would make follow-up visits impossible during the course of the study
- Collagen vascular disease such as Lupus, or scleroderma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75239
About this study
Official title: Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.
This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.
Read the detailed description
Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.
- Conditions
- Breast Cancer
- Being tested
- HylaCare, Placebo
- Keywords
- external beam radiotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HylaCareDrug
cream
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| HylaCare | Experimental | HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment. Receives: Drug: HylaCare |
| Placebo | Placebo comparator | The patient is her own control. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Skin Toxicity Per NCI-CTC v4.0
NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Measured: Week 5 during radiation therapy
Acute Skin Toxicity Per NCI-CTC v4.0
NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Measured: Week 2 post-radiation therapy
Acute Skin Toxicity Per Investigator Grading Scale
Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin
- = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema
- = erythema with dry desquamation
- = wet desquamation </= 2 cm
- = wet desquamation from 2.1 - 5cm
- = wet desquamation from 5.1 - 9 cm
- = wet desquamation > 9.1 cm
Measured: Week 5 during radiation therapy
Acute Skin Toxicity Per Investigator Grading Scale
Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with
0 = normal skin
- = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema
- = erythema with dry desquamation
- = wet desquamation </= 2 cm
- = wet desquamation from 2.1 - 5cm
- = wet desquamation from 5.1 - 9 cm
- = wet desquamation > 9.1 cm
Measured: Week 2 post-radiation therapy
Secondary outcomes (1)
Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions
Acute skin toxicity, as measured by number of participants with skin reactions via self assessment
Measured: Week 5 during radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startAug 2012
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asal Rahimi, University of Texas Southwestern Medical Center
- Investigators
- Asal Rahimi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165605
- Sponsor's protocol ID
- STU 092012-058
- Status last verified
- Sep 2020
- First submitted
- 19 Dec 2013
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rahimi A, Mohamad O, Albuquerque K, Kim DWN, Chen D, Thomas K, Wooldridge R, Rivers A, Leitch M, Rao R, Haley B, Ahn C, Garwood D, Spangler A. Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial. Support Care Cancer. 2020 Mar;28(3):1481-1489. doi: 10.1007/s00520-019-04957-0. Epub 2019 Jul 4.
PubMed 31273506
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.
- ClinicalTrials.gov ID
- NCT02165605
- Acronym / sponsor ID
- STU 092012-058
- Conditions
- Breast Cancer
- Keywords
- external beam radiotherapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.
Detailed description
Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HylaCare | Experimental | Drug: HylaCareHylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment. |
| Placebo | Placebo comparator | Drug: PlaceboThe patient is her own control. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, age 18 or older
- Diagnosis of breast cancer
- Intact breast (not surgically absent)
- Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)
- Ability to understand and comply with the requirements of this study
Key exclusion criteria (7 listed)
- Women who are pregnant or lactating
- Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
- Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
- Severe renal failure creatinine > 3.0 within 6 months of study registration
- Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
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 |
|---|---|---|
| HylaCarecream | Drug | HylaCare |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Acute Skin Toxicity Per NCI-CTC v4.0
Time frame: Week 5 during radiation therapy
NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Acute Skin Toxicity Per NCI-CTC v4.0
Time frame: Week 2 post-radiation therapy
NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.
Acute Skin Toxicity Per Investigator Grading Scale
Time frame: Week 5 during radiation therapy
Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin 1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema 2. = erythema with dry desquamation 3. = wet desquamation </= 2 cm 4. = wet desquamation from 2.1 - 5cm 5. = wet desquamation from 5.1 - 9 cm 6. = wet desquamation > 9.1 cm
Acute Skin Toxicity Per Investigator Grading Scale
Time frame: Week 2 post-radiation therapy
Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin 1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema 2. = erythema with dry desquamation 3. = wet desquamation </= 2 cm 4. = wet desquamation from 2.1 - 5cm 5. = wet desquamation from 5.1 - 9 cm 6. = wet desquamation > 9.1 cm
1 secondary outcome
Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions
Time frame: Week 5 during radiation therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31273506Rahimi A, Mohamad O, Albuquerque K, Kim DWN, Chen D, Thomas K, Wooldridge R, Rivers A, Leitch M, Rao R, Haley B, Ahn C, Garwood D, Spangler A. Novel hyaluronan formulation for preventing acute skin reactions in breast during radiotherapy: a randomized clinical trial. Support Care Cancer. 2020 Mar;28(3):1481-1489. doi: 10.1007/s00520-019-04957-0. Epub 2019 Jul 4.
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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.
Asal Rahimi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HylaCare in people with Breast Cancer, run by University of Texas Southwestern Medical 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 7 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 22 Oct 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acute Skin Toxicity Per NCI-CTC v4.0 (time frame: Week 5 during radiation therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165605, which also lists 1 linked publication.
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 22 Oct 2020.