Clinical trial · Interventional
Novel Skin Care Product for the Management of Acute Radiodermatitis
Evaluation of a Novel Skin Care Product for the Management of Acute Radiodermatitis in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Notwithstanding the continuous progress in cancer treatment, patients with cancer still have to cope with quality of life (QoL) - impairing complications. Especially an extensive spectrum of dermatologic toxicities has been associated with cancer treatments. The number and type of cutaneous toxicities have evolved over the past 50 years, paralleling the development of new radiotherapy (RT) techniques. Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing RT. Important organizations in the field of oncology and supportive care, such as the MASCC, the ASCO, and the ESMO, have developed guidelines for the management of cancer therapy- related cutaneous toxicities based on available scientific evidence. Still, for some interventions, the evidence of recommendation is moderate to insufficient. Therefore, it is essential to elucidate other new potential management strategies for dermatological complications of cancer treatment. Based on the previously mentioned supportive care guidelines for the RTskin project, a novel emollient to tackle ARD has been developed. The RTskin project general aim is to evaluate the efficacy of a novel skincare product to manage ARD in breast cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Dermatitis | — | UNRESOLVED | — |
| Radiodermatitis; Acute | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrating emollient for acute radiodermatitis | Other | — | UNRESOLVED |
| Standard institutional skin care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Will receive the standard institutional skin care for acute radiodermatitis
- interventionNames
- Other: Standard institutional skin care
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Will receive the novel, self-prepared skin care product
- interventionNames
- Other: Hydrating emollient for acute radiodermatitis
Primary outcomes (3)
- measure
- Skin reaction evaluation
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast cancer and underwent lumpectomy or mastectomy * Scheduled for radiotherapy: hypofractionation regimen (16 or 16+5 boost fractions) at the Jessa Hospital (Hasselt, BE) * Age ≥ 18 years * Able to comply to the study protocol * Able to sign written informed consent * Signed written informed consent Exclusion Criteria: * Previous irradiation to the breast region * Metastatic disease * Patients with pre-existing skin rash, ulceration or open wound in the treatment area * Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator •- Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
References
Publications (1)
- DERIVEDRobijns J, Van Bever L, Hermans S, Claes M, Lodewijckx J, Lenaerts M, Tuts L, Vandaele E, Vinken E, Noe L, Verboven K, Maes A, Van de Velde AS, Bulens P, Bulens P, Van den Bergh L, Mebis J. A novel, multi-active emollient for the prevention of acute radiation dermatitis in breast cancer patients: a randomized clinical trial. Support Care Cancer. 2023 Oct 11;31(12):625. doi: 10.1007/s00520-023-08096-5. PMID 37819539