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It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. For this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in Primary Care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). The main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Local administration of the Alantel (R) cream on the affected skin |
|
| Control group | Placebo Comparator | Local administration of the Placebo cream on the affected skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) | Combination Product | Application on the affected skin of the cream to be tested |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of radiation-induced dermatitis | three weeks | |
| Analog visual scale | Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..) | three weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cordoba | Córdoba | 14011 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38273379 | Derived | Jimenez-Garcia C, Perula-de Torres LA, Villegas-Becerril E, Munoz-Gavilan JJ, Espinosa-Calvo M, Montes-Redondo G, Romero-Rodriguez E; Alantel Trial Collaborative Group. Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials). Trials. 2024 Jan 25;25(1):84. doi: 10.1186/s13063-024-07901-8. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000713170 | Chamomile extract |
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Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study
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Double blind: both the patient and the healthcare professional do not know if the cream to be tested or the placebo is applied
| Usual treatment | Combination Product | Application on the affected skin of the emollient and moisturizing substance |
|
| D017437 |
| Skin and Connective Tissue Diseases |