Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Effectivenes and Safety of a Cream of Aloe Vera, Camomila and Tomillo (Alantel) for Profilaxis or Treatmment of Deratitis by Radiotheraphy in Patients With Breast Cancer

Conditions
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DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Intervention / Treatment
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* Combination Product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)
* Combination Product: Usual treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 14 years of age or older Diagnosed with cancer and who are or have recently received radiotherapy treatment. We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2. Exclusion Criteria: Patients with dermal lesions in grade greater than 2. Skin cancer invasion or distant tumor metastasis. Concurrent chemotherapy with RT, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.). History of hypersensitivity reaction to any of the ingredients of the studio cream. Participants involved in other clinical trials within that month.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Local administration of the Alantel (R) cream on the affected skin | Combination Product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)<br>* Application on the affected skin of the cream to be tested<br>|
| Placebo Comparator: Control group<br>Local administration of the Placebo cream on the affected skin | Combination Product: Usual treatment<br>* Application on the affected skin of the emollient and moisturizing substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BREAST CANCER, DERMATITIS