Protective cream for skin during radiotherapy
Development of a Protective Cream Against Radiodermatitis Caused by Radiotherapy.
This study is testing a new cream to see if it can help protect the skin of patients getting radiotherapy for head and neck cancer from painful skin reactions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Drugs / interventions | radiation, cetuximab, chemotherapy |
| Locations | 1 site (Valencia) |
| Trial ID | NCT05886673 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new topical cream designed to protect against radiodermatitis in patients undergoing radiotherapy for squamous cell carcinoma of the head and neck. Conducted in two hospitals in Valencia, the study involves 82 patients who will be randomly assigned to receive either the experimental cream or standard skin care. The primary goal is to reduce the incidence of severe radiation dermatitis, while secondary objectives include minimizing the severity of skin reactions. The trial employs a double-blind, controlled methodology to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with localized squamous cell carcinoma of the head and neck who are about to start radiotherapy.
Not a fit: Patients with distant metastases, prior radiation therapy for the same condition, or certain dermatological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this cream could significantly reduce the incidence and severity of skin reactions in patients receiving radiotherapy.
How similar studies have performed: While similar protective creams have been tested, this specific approach is novel in its application for radiodermatitis in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Valencia
- Medical Reserarch Institute La Fe — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio J Conde Moreno — Medical Research Institut La Fe
- Study coordinator: Antonio J Conde Moreno
- Email: antoniojconde@gmail.com
- Phone: +34 649 03 98 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.