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

Andalusian Health Service

Status: Completed

Conditions: DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Treatments: Combination Product: Usual treatment; Combination Product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)

Study type: Interventional

Funder types: Other

Identifiers

NCT04116151

Alantel

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Local administration of the Alantel (R) cream on the affected skin

Treatment:

Combination Product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)

Control group

Placebo Comparator group

Description:

Local administration of the Placebo cream on the affected skin

Treatment:

Combination Product: Usual treatment