Clinical trial · Interventional
Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients
Double Blind Study - Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients
NCT03941665CI-TRIAL-00048616completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of the study is to evaluate the effect of Gelronate gel, NaHA based product (medical device for topical application) vs. Aloevera gel, in prevention or minimizing of radiation induced skin reaction in breast cancer patients
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aloevera | Other | — | UNRESOLVED |
| Gelronate | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gelronate
- description
- Tested new medical device
- interventionNames
- Device: Gelronate
- Other: Aloevera
- type
- ACTIVE_COMPARATOR
- label
- Aloevera
- description
- Current product used by the medical center
- interventionNames
- Device: Gelronate
- Other: Aloevera
Primary outcomes (3)
- measure
- Development and degree of any skin reaction
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged at least 18 years with unilateral breast following lumpectomy +/- chemotherapy * Planned to receive 42.4 Gy whole breast irradiation +/- boost to tumor bed. * ECOG performance status 0-2. * Capable of giving written informed consent. * No co-morbidities known to affect radiotherapy reactions. * No co-existing acute or chronic skin disease. * No evidence of infection or inflammation of breast to be treated. * Not receiving chemotherapy during radiotherapy course. Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study. Exclusion Criteria: * Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation. * Prior radiotherapy to the chest wall. * Collagen vascular disease. * Participation in other clinical study.
References
Publications (2)
- RESULTPrimavera G, Carrera M, Berardesca E, Pinnaro P, Messina M, Arcangeli G. A double-blind, vehicle-controlled clinical study to evaluate the efficacy of MAS065D (XClair), a hyaluronic acid-based formulation, in the management of radiation-induced dermatitis. Cutan Ocul Toxicol. 2006;25(3):165-71. doi: 10.1080/15569520600860009. PMID 16980242
- RESULTLeonardi MC, Gariboldi S, Ivaldi GB, Ferrari A, Serafini F, Didier F, Mariani L, Castiglioni S, Orecchia R. A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis. Eur J Dermatol. 2008 May-Jun;18(3):317-21. doi: 10.1684/ejd.2008.0396. Epub 2008 May 13. PMID 18474463