Clinical trial · Observational
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
Phase II, Double Blinded, Randomized Study of R1 and R2 (Waterjel) Verses Aloe Vera Jell for the Prevention and Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
NCT01597921CI-TRIAL-00007799terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped due to unbalanced side effects
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.
Conditions
Conditions (3)
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 |
| Erythema | — | UNRESOLVED | — |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patient receiving RT
- description
- Total dose:2Gy/Fx
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy. 2. Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy. 3. Patient able to understand the study designed and cooperate with instructions of use. 4. Patient able to sign informed consent Exclusion Criteria: 1. Woman with lactose allergy (lactose intolerance are eligible) 2. Woman with known connective tissue disorder 3. Woman with uncontrolled diabetes 4. Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx 5. Woman who is unable to sign an informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.