Clinical trial · Interventional
Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis
An Open-Label, Randomized Study to Evaluate the Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis In Breast Cancer Patients Undergoing Radiation Therapy.
NCT01923220CI-TRIAL-00011775ARDunknownEarly Phase 1ClinicalTrials.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)
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aloe Vera Jel | Other | — | UNRESOLVED |
| HO/02/02 20µg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HO/02/02
- description
- Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily
- interventionNames
- Drug: HO/02/02 20µg
- type
- SHAM_COMPARATOR
- label
- Aloe Vera Jel
- description
- To be applied topically
- interventionNames
- Other: Aloe Vera Jel
Primary outcomes (1)
- measure
- Number of patients using HO/02/02 20µg that developed grade 1-4 radiation dermatitis during adjuvant radiation therapy for breast cancer compared to SoC (Aloe Vera) commonly used as standard of care treatment.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients 18 years old and above. * Histology confirmed unilateral breast cancer following lumpectomy * Planned to receive 50 Gy, whole breast XRT and regional lymph nodes radiation. * ECOG performance status 0-2 * Completed Chemotherapy 3 weeks prior to XRT (if applicable) * Patient should be available for the entire study period, and be able and willing to adhere to protocol requirements; * Patient must sign an informed consent form prior to undergoing any study-related procedures Exclusion Criteria: * Known uncontrolled diabetes * Prior radiation to breast * Known connective tissue disorder * Known skin disease over the treated breast * Prior burn over treated area * Evidence of infection or inflammation of breast to be treated. * Receiving biological therapy or hormone therapy (other than Herceptin) during radiation treatment/study duration and 4 weeks prior to study entry. * Pre-existing skin breakdown within the planned radiotherapy field at the time of study entry. * Pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the Investigator. * Participation in another investigational drug or vaccine trial concurrently or within 30 days. * Use of any other topical or systemic treatments aimed at radiation dermatitis. * Use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation
References
Publications (0)
Data not yet available
No reference posted for this study.