Clinical trial · Interventional
KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer
Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No longer pursuing study at our site.
Summary
Brief summary (as posted)
This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Skin Reactions Secondary to Radiation Therapy | — | UNRESOLVED | — |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dermatologic complications management/prevention | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (KeraStat Skin Therapy)
- description
- Patients apply KeraStat Skin Therapy topically BID during radiation therapy.
- interventionNames
- Procedure: dermatologic complications management/prevention
- Other: questionnaire administration
Primary outcomes (1)
- measure
- Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity
- timeFrame
- Up to 2 months after completion of radiation therapy
- description
- At each time point the proportion of women who have RT-induced EASR present will be estimated and a 95% confidence interval will be calculated around this estimate.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ \[DCIS\]) * Status post-lumpectomy, -quadrantectomy, or -mastectomy * Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes * Total dose \>= 40Gy * Dose per fraction \>= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens * Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens * Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist * Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist * Patients who are able and willing to sign protocol consent form Exclusion Criteria: * Prior radiation to the involved breast or chest wall * Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion) * Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed) * Patients undergoing partial breast irradiation * Patients who have undergone MammoSite® or any other form of brachytherapy * Patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed * Patients who are pregnant or breastfeeding
References
Publications (0)
Data not yet available