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

Not Applicable

Completed

• Conditions: DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER
• Interventions: Combination Product: Usual treatment

• Registration Number: NCT04116151
• Lead Sponsor: Hospital Universitario Reina Sofia de Cordoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Study Start: 2022-07-19
• Primary Completion: 2023-05-30
• Study Completion: 2023-07-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Usual treatment	Local administration of the Placebo cream on the affected skin

Primary Outcome Measures

Name	Time	Method
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, ..)

Trial Locations

Locations (1)

University of Cordoba; 🇪🇸 Córdoba, Spain