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NCT00876642
Phase III Trial Comparing Best Supportive Care to Aloe Vera Gel as a Prophylactic Agent for Radiation Induced Skin Toxicity
Phase 3 trial testing Aloe vera gel in Radiation Dermatitis in 137 participants. Completed in 1 December 2008.
1 September 2008
Quick facts
| Lead sponsor | Marilia Medicine School |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 137 |
| Start date | 1 March 2007 |
| Primary completion | 1 September 2008 |
| Estimated completion | 1 December 2008 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Aloe vera gel
Conditions studied
- Radiation Dermatitis — all drugs for Radiation Dermatitis →
Sponsor
Marilia Medicine School
Who can join
Adults 18 to 85, any sex, with Radiation Dermatitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- Acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer.
Sponsor's own description
Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years. Although initially used for the treatment of chest wall recurrences after mastectomy and for advanced inoperable disease, RT has evolved into a critical component of early therapy for women with an intact breast following lumpectomy and for mastectomized women who are at high risk for local failure. Currently breast cancer patients need a multidisciplinary management including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco regional control of the disease. It is estimated that 87% of these women will develop some degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist desquamation. Topical agents, such as corticosteroid creams and other products including Aquaphor (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of radiotherapy. The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream for the prevention of acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary objectives were to assess pain, treatment interruption as a result of skin reactions, and the quantity of life during the treatment.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Radiation-induced skin reactions: oxidative damage mechanism and antioxidant protection.
Liu C, Wei J, Wang X, Zhao Q, et al · · 2024 · cited 8× · PMID 39450273 · DOI 10.3389/fcell.2024.1480571 -
Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4
Verify or expand the search:
- PubMed search for NCT00876642
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Aloe vera gel
Trials testing the same drug.
- NCT07346677 — Comparing of Sesame Oil, Nitroglycerin Ointment, and Aloe Vera Gel · Phase 2 · not yet recruiting
- NCT06862817 — Comparison Between the Effect of Aloe Vera and Benzydamine Hydrochloride Mouth Gel on Prevention of Pain and Progression · Phase 1, PHASE2 · completed
- NCT06879366 — Evaluation of the Efficacy of Aloe-Vera el Versus Bezydamine Hydrochloride in the Prevention of Radiation Induced Oral M · Phase 4 · completed
- NCT04753775 — RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS. · NA · completed
Other recruiting trials for Radiation Dermatitis
Currently open trials in the same condition.
- NCT07086638 — ROS-Scavenging Nanozyme Combined With Thermotherapy Alleviate Radiation Dermatitis in Patients With Head and Neck Cancer · NA · recruiting
- NCT07081074 — ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head · NA · recruiting
- NCT07064577 — Novel ROS-scavenging Nanoenzymes for the Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer · NA · recruiting
- NCT06915857 — Topical Betamethasone Versus Moisturizer in Preventing Radiation Dermatitis in Large-Breasted Patients Treated in the Pr · Phase 3 · recruiting
- NCT06729814 — Prospective Assessment of Acute Skin Toxicities in Breast Cancer Patients Undergoing Retreatment with 40 Gy in 15 Fracti · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00876642 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Marilia Medicine School
- Last refreshed: 6 April 2009
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00876642.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing