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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-19

Study Completion Date

2023-07-30

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.

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Detailed Description

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Conditions

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DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Double blind: both the patient and the healthcare professional do not know if the cream to be tested or the placebo is applied

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

Application on the affected skin of the cream to be tested

Control group

Local administration of the Placebo cream on the affected skin

Group Type PLACEBO_COMPARATOR

Usual treatment

Intervention Type COMBINATION_PRODUCT

Application on the affected skin of the emollient and moisturizing substance

Interventions

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

Application on the affected skin of the cream to be tested

Intervention Type COMBINATION_PRODUCT

Usual treatment

Application on the affected skin of the emollient and moisturizing substance

Intervention Type COMBINATION_PRODUCT

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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes