N/A N=57 Randomized Supportive Care

Radiotherapy Related Skin Toxicity: Mepitel® vs. Standard Care in Patients With Locally Advanced Head-and-Neck Cancer

Head and Neck Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT03047174 ↗

Enrolled (actual)

Serious AEs

29.8%

Results posted

Mar 2020

Primary outcome: Primary: Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set) — 3; 9; 6; 18 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mepitel® Film (Other); Standard Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospital Schleswig-Holstein
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)	3; 9; 6; 18	—
SECONDARY Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set)	4; 15; 3; 11	—
SECONDARY Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set)	0; 0; 9; 27	—
SECONDARY Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set)	1; 3; 6; 23	—
SECONDARY Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)	8; 10; 15; 18	—
SECONDARY Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)	15; 16; 8; 11	—
SECONDARY Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)	0; 0; 23; 28	—
SECONDARY Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)	1; 3; 22; 24	—
SECONDARY Median Number of Radiation Fractions Until Occurence of Grade 2 Dermatitis	23; 23	—
SECONDARY Median Pain Score at the Irradiated Skin at 50 Gy	0.0; 0.0	—
SECONDARY Median Pain Score at the Irradiated Skin at 60 Gy	2.0; 2.5	—
SECONDARY Change in Quality of Life Between Screening and 50 Gy of Radiotherapy	11.11; 19.79; -2.22; -15.0; 0.0; -16.67	—

Summary

The aim for the present study named RAREST (RAdiotherapy RElated Skin Toxicity) is to compare the new dressing with the standard skin care. 168 patients receiving radiotherapy alone or radiochemotherapy for locally advanced head-and-neck cancer will be included. The primary aim is to investigate the rate of patients experiencing severe, stressful radiation dermatitis. The skin status will daily be inspected and assessed by specially trained doctors and nursing staff. It is expected that the new self-adhesive dressing is superior to standard care with respect to prevention of grade ≥2 radiation dermatitis in patients receiving radiotherapy or radio(chemo)therapy for a head-and-neck tumor. Thus, the dressing would be well qualified to become a new standard procedure at the skin care of patients with a head-neck tumor.

Eligibility Criteria

Inclusion Criteria

Histologically proven locally advanced squamous cell carcinoma of the head-and-neck (SCCHN)
Conventionally fractionated (5x2 Gy per week) definitive or adjuvant radio(chemo)therapy
Age ≥18 years
Written informed consent
Capacity of the patient to contract

Exclusion Criteria

N3 stage (lymph nodes >6 cm)
Distant metastases (M1)
Pregnancy, Lactation
Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)
Expected non-compliance

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03047174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.