Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients
Purpose: Radiotherapy (RT) is commonly used in the treatment of breast cancer and often, despite advances in fractionated dosing schedules, produces undesirable skin toxicity. The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraN...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2024-01-01
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| Series: | Technology in Cancer Research & Treatment |
| Online Access: | https://doi.org/10.1177/15330338231222137 |
| _version_ | 1797361436123463680 |
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| author | Karen M. Winkfield MD, PhD Ryan T. Hughes MD Doris R. Brown MD, PhD Ryan M. Clohessy PhD Robert C. Holder PhD Gregory B. Russell MS Alexis F. Rejeski MBA Luke R. Burnett PhD |
| author_facet | Karen M. Winkfield MD, PhD Ryan T. Hughes MD Doris R. Brown MD, PhD Ryan M. Clohessy PhD Robert C. Holder PhD Gregory B. Russell MS Alexis F. Rejeski MBA Luke R. Burnett PhD |
| author_sort | Karen M. Winkfield MD, PhD |
| collection | DOAJ |
| description | Purpose: Radiotherapy (RT) is commonly used in the treatment of breast cancer and often, despite advances in fractionated dosing schedules, produces undesirable skin toxicity. The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraNetics, Inc., Winston Salem, NC, USA) to manage the symptoms of radiation dermatitis (RD) in breast cancer patients undergoing RT. Materials and Methods: A total of 24 subjects were enrolled on this single-center, randomized, open-label study. Participants were randomly assigned to KC or standard of care (SOC, patient's choice of a variety of readily available creams or moisturizers). Patients were asked to apply the assigned treatment to the irradiated area twice daily, beginning with day 1 of RT, through 30 days post-RT. The primary outcome was compliance of use. Secondary outcomes included safety and tolerability of KC, as well as RD severity assessed using the Radiation Therapy Oncology Group (RTOG) scale and the patient-reported Dermatology Life Quality Index (DLQI). Results: All subjects in the KC group were assessed as compliant with no adverse events. The rate of RTOG Grade 2 RD was lower in the KC group (30.8%) compared to the SOC group (54.5%, P = .408). At the final RT visit, the mean RTOG RD score was lower in the KC group (1.0) versus the SOC group (1.4). Similarly, patient-reported quality of life measured by the DLQI at the end of RT was improved in the KC group (mean 4.25, small effect) versus the SOC group (mean 6.18, moderate effect, P = .412). Conclusions: KC was safe and well tolerated with no adverse events. Though efficacy measures were not powered to draw definitive conclusions, trends and clinical assessments suggest that there is a benefit of using KC compared to SOC for breast cancer patients treated with RT, and a larger powered study for efficacy is warranted. Trial Registry: This clinical trial is registered as NCT03374995 titled KeraStat(R) Cream for Radiation Dermatitis. |
| first_indexed | 2024-03-08T15:53:40Z |
| format | Article |
| id | doaj.art-7032f69679eb46f2b676f99f2d779881 |
| institution | Directory Open Access Journal |
| issn | 1533-0338 |
| language | English |
| last_indexed | 2024-03-08T15:53:40Z |
| publishDate | 2024-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Technology in Cancer Research & Treatment |
| spelling | doaj.art-7032f69679eb46f2b676f99f2d7798812024-01-09T03:03:19ZengSAGE PublishingTechnology in Cancer Research & Treatment1533-03382024-01-012310.1177/15330338231222137Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer PatientsKaren M. Winkfield MD, PhD0Ryan T. Hughes MD1Doris R. Brown MD, PhD2Ryan M. Clohessy PhD3Robert C. Holder PhD4Gregory B. Russell MS5Alexis F. Rejeski MBA6Luke R. Burnett PhD7 Department of Radiation Oncology, , Winston Salem, NC, USA Department of Radiation Oncology, , Winston Salem, NC, USA Department of Radiation Oncology, , Winston Salem, NC, USA KeraNetics, Inc., Winston Salem, NC, USA KeraNetics, Inc., Winston Salem, NC, USA Department of Biostatistics and Data Science, Division of Public Health Sciences, , Winston Salem, NC, USA KeraNetics, Inc., Winston Salem, NC, USA KeraNetics, Inc., Winston Salem, NC, USAPurpose: Radiotherapy (RT) is commonly used in the treatment of breast cancer and often, despite advances in fractionated dosing schedules, produces undesirable skin toxicity. The purpose of this study was to evaluate the feasibility of using a keratin-based topical cream, KeraStat® Cream (KC; KeraNetics, Inc., Winston Salem, NC, USA) to manage the symptoms of radiation dermatitis (RD) in breast cancer patients undergoing RT. Materials and Methods: A total of 24 subjects were enrolled on this single-center, randomized, open-label study. Participants were randomly assigned to KC or standard of care (SOC, patient's choice of a variety of readily available creams or moisturizers). Patients were asked to apply the assigned treatment to the irradiated area twice daily, beginning with day 1 of RT, through 30 days post-RT. The primary outcome was compliance of use. Secondary outcomes included safety and tolerability of KC, as well as RD severity assessed using the Radiation Therapy Oncology Group (RTOG) scale and the patient-reported Dermatology Life Quality Index (DLQI). Results: All subjects in the KC group were assessed as compliant with no adverse events. The rate of RTOG Grade 2 RD was lower in the KC group (30.8%) compared to the SOC group (54.5%, P = .408). At the final RT visit, the mean RTOG RD score was lower in the KC group (1.0) versus the SOC group (1.4). Similarly, patient-reported quality of life measured by the DLQI at the end of RT was improved in the KC group (mean 4.25, small effect) versus the SOC group (mean 6.18, moderate effect, P = .412). Conclusions: KC was safe and well tolerated with no adverse events. Though efficacy measures were not powered to draw definitive conclusions, trends and clinical assessments suggest that there is a benefit of using KC compared to SOC for breast cancer patients treated with RT, and a larger powered study for efficacy is warranted. Trial Registry: This clinical trial is registered as NCT03374995 titled KeraStat(R) Cream for Radiation Dermatitis.https://doi.org/10.1177/15330338231222137 |
| spellingShingle | Karen M. Winkfield MD, PhD Ryan T. Hughes MD Doris R. Brown MD, PhD Ryan M. Clohessy PhD Robert C. Holder PhD Gregory B. Russell MS Alexis F. Rejeski MBA Luke R. Burnett PhD Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients Technology in Cancer Research & Treatment |
| title | Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients |
| title_full | Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients |
| title_fullStr | Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients |
| title_full_unstemmed | Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients |
| title_short | Randomized Pilot Study of a Keratin-based Topical Cream for Radiation Dermatitis in Breast Cancer Patients |
| title_sort | randomized pilot study of a keratin based topical cream for radiation dermatitis in breast cancer patients |
| url | https://doi.org/10.1177/15330338231222137 |
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