Development of a Protective Cream Against Radiodermatitis Caused by Radiotherapy.

Radiodermatitis Clinical Trial

— RADIOCREMVAL  

Official title:

Development of a Protective Cream Against Radiodermatitis Caused by Radiotherapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886673
• Other study ID #: 2022-963-1
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Antonio J Conde Moreno
• Phone: +34 649 03 98 66
• Email: antoniojconde[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study cream is to be evaluated in a multicenter, randomized, controlled clinical study carried out in 2 hospitals, in the Radiation Oncology service of Valencia to evaluate its radioprotective and radiomitigation effect in the prophylactic treatment of acute radiodermatitis caused by radiation.

A total of 82 patients with squamous cell carcinoma of the head and neck (SCCHN) were are going to be randomized in a study. Patients receive the study topical cream or "standard" skin care from Hospitals where the study is carried out. All patients will be treated with a combination of fractionated radiotherapy and platinum-based chemotherapy OR cetuximab for curative purposes.

The main objective of the study cream is to obtain a reduction in the number of patients who experience acute radiation dermatitis grade 3 or 4 (NCI CTCAE version 4.03) to grade 2, the last day of treatment. As a secondary objective, to obtain a reduction in the number of patients experiencing grade 3 or 4 to grade 0 acute radiation dermatitis, within a month of finish treatment. All patients will be evaluated periodically. The skin is photographed irradiated and all changes of radiation dermatitis are classified. The valuation of the radiodermatitis will be carried out objectively using a thermograph. In addition, the patients who complete questionnaires about their quality of life (QLQ-C30). These Questionnaires are answered in weeks 1, 2, 3 and 4 of treatment, as well as at the end of the radiation therapy or chemotherapy.

For the primary endpoint of radiodermatitis with CTCAE ≥ grade 2, assessments are made according to the protocol (PP), in addition to the primary intention-to-treat (ITT) approach. In this PP analysis, the patients are excluded according to protocol definition or meeting decisions preanalysis, respectively. The study is designed as a randomized trial with a 1:1 allocation to the two groups.

The secondary objective is to study a reduction in the percentage of patients experiencing radiation dermatitis with a maximum CTCAE grade 3 or 4 during the period of treatment and in the follow-up period of one month, thanks to the application of the cream of study.

Description:

The study will be a randomized, controlled, parallel, prospective, double-blind, two-armed clinical study with a cosmeceutical product.

The creams (experimental cream (CE) and standard of care (SC)) will be randomly distributed among the patients, so that 50% receive CE and the other 50% SC. Each tube will have a number whose content does not neither the evaluators and the patients will know.

In a period between January 2023 and June 2023, the radiation oncology services of Hospitals La Fe and Clinic de Valencia conducted a study on 82 patients with SCCHN. what will they be undergoing external beam radiotherapy with or without concomitant chemotherapy.

Radiotherapy treatment uses techniques of modulated intensity of the radiation beam (IMRT or VMAT) image-guided (IGRT) that offer very high precision in the daily administration of treatment, improving the tolerance of healthy tissues and the quality life of patients.

Patients will be divided into two groups:

Group A (intervention, CE): this group will receive the topical application of the study cream.

Group B (control, SC): standard care will be applied to this group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed localized (nonmetastatic) SCCHN.

• 18 years or older, with ECOG (Eastern Cooperative Oncology Group) Performance Status of performance from 0 to 2, a life expectancy of 6 months or more, and with signed informed consent.

• Intact skin at the start of radiotherapy.

Exclusion Criteria:

• Distant metastases, prior radiation therapy for SCCHN.

• Ongoing participation in any other study or clinical trial.

• Pregnant or lactating.

• Hypersensitivity to any of the components of the study cream.

• Prior or concurrent cancer within 5 years of study start and any other social or medical condition that may affect participation in or evaluation of the study will be excluded.

• History of collagen disease, such as systemic lupus erythematosus and/or scleroderma.

• Present dermatological conditions, such as psoriasis, bullous pemphigus or epidermolysis bullosa or bullosa.

• Inflammatory changes in the skin of the area to be irradiated.

Related Conditions & MeSH terms

• Radiodermatitis

Intervention

Other:
• experimental cream
experimental cream
• standard of care
standard of care

Locations

Country	Name	City	State
Spain	Medical Reserarch Institute La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Antonio J. Conde Moreno	University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction the occurrence of grade 2 radiodermatitis	Reduction (in the progression to severe radiation dermatitis) of the number of patients experiencing acute radiation dermatitis from grade 3 or 4 to grade 2 on the last day of treatment.	Through study completion, an average of 4 months
Primary	Delay in the occurrence of grade 2 radiodermatitis compared to the placebo group.	Delay in the occurrence of grade 2 radiodermatitis compared to the placebo group.	Through study completion, an average of 4 months
Secondary	Incidence of radiodermatitis	To compare the percentage of patients (incidence) with radiodermatitis, the degree of toxicity and the percentage of cases with radiodermatitis grade 2 or higher in patients undergoing the different treatments, in the total sample and stratified by number of radiotherapy sessions per month and at the end of treatment.; To assess and compare the time to onset of each grade of skin reaction; to identify the frequency and location of specific features of radiodermatitis.; To study the health-related quality of life perceived by patients at the beginning and at the end of radiotherapy. of radiotherapy. To evaluate and compare the local symptoms described by patients during radiotherapy treatment and treatment and assessed by PREMS-PROMS.; To compare the temperature of the irradiated area using a thermograph during radiotherapy, in the 4 visits to be made by the patient. the 4 visits to be made by the patient.	through study completion, an average of 4 months