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OpenTrials
Completed

NCT Number: NCT04116151

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

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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Key information

Conditions

DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER Breast Diseases Breast Neoplasms Dermatitis Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cordoba

Córdoba, 14011, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Combination Product

Application on the affected skin of the cream to be tested

Usual treatment

Combination Product

Application on the affected skin of the emollient and moisturizing substance

Primary outcomes

  1. Incidence of radiation-induced dermatitis

    Time frame: three weeks

  2. Analog visual scale

    Time frame: three weeks

    Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)

Sponsors and collaborators

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba

Other Gov

Registry information

Official study title

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

Acronym: Alantel

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2019
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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