Development of a Protective Cream Against Radiodermatitis Caused by Radiotherapy.

NCT05886673 | Unknown DMC

• 1 other identifier: 2022-963-1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiodermatitis

Keywords

radiodermatitis; oncology; radiotherapeutic oncology

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Incidence of radiodermatitis

  through study completion, an average of 4 months

Study Arms (2)

Study treatment

EXPERIMENTAL

The experimental cream formulation has the same components as the control plus 2% pterostilbene, 1% silibinin and 2% nicotinamide riboside.

Other: experimental cream

Control treatment

OTHER

The control cream formulation is designed to help maintaining skin hydration and texture. It contains common ingredients largely used in cosmetics: stearic acid, cetyl alcohol, liquid vaselin, isopropyl myristate, triethanolamine, methyl paraben, propyl paraben, propylene glycol, ethoxydiglycol, and water.

Other: standard of care

Interventions

experimental cream OTHER

experimental cream

Study treatment

standard of care OTHER

standard of care

Control treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed localized (nonmetastatic) SCCHN.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antonio J. Conde Moreno: lead
• University of Valencia: collaborator

Study Sites (1)

Medical Reserarch Institute La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Radiodermatitis; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Antonio J Conde Moreno

  Medical Research Institut La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio J Conde Moreno

CONTACT

+34 649 03 98 66; antoniojconde@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 2, 2023
• Study Start: March 29, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

ES (1)