Breast CarcinomaNCT03374995

Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

A study testing Best Practice, Quality-of-Life Assessment and Topical Keratin in people with Breast Carcinoma and Radiation-Induced Dermatitis, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Carcinoma, Radiation-Induced Dermatitis
What is being tested?: Best Practice, Quality-of-Life Assessment and Topical Keratin
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 26 Mar 2018to 1 Nov 2018
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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)
Area to be irradiated representing 1-10% of total body surface area (TBSA)
Able and willing to sign protocol consent form
Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
Able and willing to have photographs of the affected area taken regularly

Who cannot join

Women who are pregnant, lactating/nursing or plan to become pregnant
Previous radiation therapy to the area to be treated with radiation therapy
Receiving palliative radiation therapy
Unhealed or infected surgical sites in the irradiation area
Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
Use of oral corticosteroids or topical corticosteroids in the irradiation area

Show all 11Show fewer

Use of Erbitux
Autoimmune disease
Skin disease in target irradiation area
Smoker
Known allergy to the standard of care or ingredients in KeraStat Cream

Trial locations and contacts

1 site in 1 country.

United States1 site

Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Pilot Study: KeraStat Cream for Radiation Dermatitis

Read the detailed description

PRIMARY OBJECTIVES:

To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks).

GROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).

After completion of study treatment, patients are followed up at 4-6 weeks.

Conditions: Breast Carcinoma, Radiation-Induced Dermatitis
Being tested: Best Practice, Quality-of-Life Assessment, Topical Keratin
Medical subject headings: Breast Neoplasms, Radiodermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Topical KeratinDevice
Also called KeraStat
Given topically

Study groups in NCT03374995
Study group	Role	What they receive
Group I (topical keratin)	Experimental	Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks). Receives: Other: Quality-of-Life Assessment; Device: Topical Keratin
Group II (standard of care)	Active comparator	Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks). Receives: Other: Best Practice; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Early Adverse Skin Reactions (EASRs)
The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.
Measured: Up to 4 weeks post-RT
Change in Quality of Life
A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Measured: Baseline to up to 7 weeks
Physician Observed Improvement in Skin Appearance
Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Measured: Baseline to up to 7 weeks
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.
Measured: Baseline to up to 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 20181 Nov 2018

First posted15 Dec 2017
Study start26 Mar 2018
Primary completion1 Nov 2018
Study completion1 Nov 2018

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.
Other trials for Breast CarcinomaStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03374995
Sponsor's protocol ID: IRB00046759
Other IDs: NCI-2017-02011, CCCWFU 97417, P30CA012197
Status last verified: Feb 2020
First submitted: 29 Nov 2017
Last updated: 11 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study: KeraStat Cream for Radiation Dermatitis
ClinicalTrials.gov ID: NCT03374995
Acronym / sponsor ID: IRB00046759
Conditions: Breast Carcinoma, Radiation-Induced Dermatitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 26 Mar 2018 (actual)
Primary completion: 1 Nov 2018 (actual)
Study completion: 1 Nov 2018 (actual)
First posted: 15 Dec 2017 (actual)
Results: Posted 12 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks).

GROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).

After completion of study treatment, patients are followed up at 4-6 weeks.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group I (topical keratin)	Experimental	Other: Quality-of-Life Assessment, Device: Topical KeratinPatients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).
Group II (standard of care)	Active comparator	Other: Best Practice, Other: Quality-of-Life AssessmentPatients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)
Area to be irradiated representing 1-10% of total body surface area (TBSA)
Able and willing to sign protocol consent form
Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
Able and willing to have photographs of the affected area taken regularly

Key exclusion criteria (11 listed)

Women who are pregnant, lactating/nursing or plan to become pregnant
Previous radiation therapy to the area to be treated with radiation therapy
Receiving palliative radiation therapy
Unhealed or infected surgical sites in the irradiation area
Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)

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
Best PracticeAlso: standard of care, standard therapyReceive standard of care	Other	Group II (standard of care)
Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Group I (topical keratin), Group II (standard of care)
Topical KeratinAlso: KeraStatGiven topically	Device	Group I (topical keratin)

Primary outcome

Incidence of Early Adverse Skin Reactions (EASRs)
Time frame: Up to 4 weeks post-RT
The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.
Change in Quality of Life
Time frame: Baseline to up to 7 weeks
A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Physician Observed Improvement in Skin Appearance
Time frame: Baseline to up to 7 weeks
Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.
Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
Time frame: Baseline to up to 7 weeks
Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.

Results and safety

Results posted to the registry on 12 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I (Topical Keratin)	13	13
Group II (Standard of Care)	12	11

Primary outcome: Incidence of Early Adverse Skin Reactions (EASRs)

Time frame: Up to 4 weeks post-RT. Count of participants. Unit: Participants

Measure	Group I (Topical Keratin) n = 13	Group II (Standard of Care) n = 11
Grade I Acute Radiation Dermatitis	13	10
Grade II Acute Radiation Dermatitis	4	6
Moist Desquamation	1	0

Primary outcome: Change in Quality of Life

Time frame: Baseline to up to 7 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Group I (Topical Keratin) n = 13	Group II (Standard of Care) n = 11
Visit 1 (baseline)	0.31 (0.82)	2.73 (5.26)
Visit 2	0.77 (1.31)	1.64 (2.06)
Visit 3	2.23 (3.85)	1.91 (2.11)
Visit 4	2.85 (2.98)	2.36 (2.53)
Visit 5	4.75 (6.99)	5.27 (5.01)
Visit 6	4.25 (4.87)	6.18 (5.70)
Visit 7	0.85 (1.10)	1.00 (2.05)

Primary outcome: Physician Observed Improvement in Skin Appearance

Time frame: Baseline to up to 7 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Group I (Topical Keratin) n = 13	Group II (Standard of Care) n = 11
Visit 1 (baseline)	0.00 (0)	0.00 (0)
Visit 2	0.15 (0.36)	0.09 (0.29)
Visit 3	0.62 (0.49)	0.55 (0.50)
Visit 4	1.00 (0.68)	0.82 (0.38)
Visit 5	1.17 (0.55)	1.00 (0.43)
Visit 6	1.00 (0)	1.36 (0.64)
Visit 7	0.23 (0.42)	0.30 (0.46)

Primary outcome: Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale

Time frame: Baseline to up to 7 weeks. Count of participants. Unit: Participants

Measure	Group I (Topical Keratin) n = 13	Group II (Standard of Care) n = 11
Visit 1 (baseline)	2	4
Visit 2	6	6
Visit 3	8	8
Visit 4	11	7
Visit 5	11	10
Visit 6	10	10
Visit 7	7	2

Adverse events

Time frame: Up to 30 days post radiation therapy. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (Topical Keratin)	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Group II (Standard of Care)	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Karen Winkfield principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 11 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 11 Jun 2024. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 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?

Incidence of Early Adverse Skin Reactions (EASRs) (time frame: Up to 4 weeks post-RT). 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 NCT03374995.

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 11 Jun 2024.