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

Primary Purpose

DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)
Usual treatment
Sponsored by
Hospital Universitario Reina Sofia de Cordoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER focused on measuring BREAST CANCER, DERMATITIS

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of CordobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

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

Local administration of the Placebo cream on the affected skin

Outcomes

Primary Outcome Measures

Incidence of radiation-induced dermatitis
Analog visual scale
Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)

Secondary Outcome Measures

Full Information

First Posted
September 18, 2019
Last Updated
August 8, 2023
Sponsor
Hospital Universitario Reina Sofia de Cordoba
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1. Study Identification

Unique Protocol Identification Number
NCT04116151
Brief Title
Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer
Acronym
Alantel
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Reina Sofia de Cordoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER
Keywords
BREAST CANCER, DERMATITIS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study
Masking
ParticipantCare Provider
Masking Description
Double blind: both the patient and the healthcare professional do not know if the cream to be tested or the placebo is applied
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Local administration of the Alantel (R) cream on the affected skin
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Local administration of the Placebo cream on the affected skin
Intervention Type
Combination Product
Intervention Name(s)
Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)
Intervention Description
Application on the affected skin of the cream to be tested
Intervention Type
Combination Product
Intervention Name(s)
Usual treatment
Intervention Description
Application on the affected skin of the emollient and moisturizing substance
Primary Outcome Measure Information:
Title
Incidence of radiation-induced dermatitis
Time Frame
three weeks
Title
Analog visual scale
Description
Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)
Time Frame
three weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Angel Pérula De Torres, Ph D
Phone
+34659681627
Email
luisangel.perula@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Celia Jiménez Garcia, Ph D
Phone
600027731
Email
cejiga@gmail.com
Facility Information:
Facility Name
University of Cordoba
City
Córdoba
ZIP/Postal Code
14011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Pérula, Ph D
Phone
+34 659681627
Email
luisangel.perula@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis Angel Pérula De Torres, Ph D
Phone
+34659681627
Email
luisangel.perula@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis Angel Pérula De Torres, Ph D
First Name & Middle Initial & Last Name & Degree
Celia Jimenez Garcia, Ph D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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