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

NCT04116151 | Completed

• 1 other identifier: Alantel
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Keywords

BREAST CANCER; DERMATITIS

Outcome Measures

Primary Outcomes (2)

• Incidence of radiation-induced dermatitis

  three weeks

• Analog visual scale

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

  three weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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

Control group

PLACEBO COMPARATOR

Local administration of the Placebo cream on the affected skin

Combination Product: Usual treatment

Interventions

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

Application on the affected skin of the cream to be tested

Intervention group

Usual treatment COMBINATION_PRODUCT

Application on the affected skin of the emollient and moisturizing substance

Control group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Reina Sofia de Cordoba: lead

Study Sites (1)

University of Cordoba

Córdoba, 14011, Spain

Location

Related Publications (1)

• Jimenez-Garcia C, Perula-de Torres LA, Villegas-Becerril E, Munoz-Gavilan JJ, Espinosa-Calvo M, Montes-Redondo G, Romero-Rodriguez E; Alantel Trial Collaborative Group. Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials). Trials. 2024 Jan 25;25(1):84. doi: 10.1186/s13063-024-07901-8.

  PMID: 38273379 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Dermatitis

Interventions

Chamomile extract

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blind: both the patient and the healthcare professional do not know if the cream to be tested or the placebo is applied
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 4, 2019
• Study Start: July 19, 2022
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)