DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER
Conditions
Keywords
BREAST CANCER, DERMATITIS
Brief summary
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.
Interventions
COMBINATION_PRODUCTCosmetic cream (Alantel (R): aloe vera, chamomile and thime)
Application on the affected skin of the cream to be tested
COMBINATION_PRODUCTUsual treatment
Application on the affected skin of the emollient and moisturizing substance
Sponsors
Hospital Universitario Reina Sofia de Cordoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blind: both the patient and the healthcare professional do not know if the cream to be tested or the placebo is applied
Intervention model description
Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of radiation-induced dermatitis | three weeks | — |
| Analog visual scale | three weeks | Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..) |
Countries
Spain
Outcome results
None listed