Clinical trial NCT04110977: A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
Official title: RAdiotherapy RElated Skin Toxicity: a Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radiation Dermatitis
Radiation-induced Oral Mucositis
Keywords: Head-and-neck cancer
radiotherapy
radiation dermatitis
oral mucositis
reminder app
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, active-controlled, parallel-group trial
Primary purpose: PREVENTION

Brief summary: The goal of this randomized trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN). The primary endpoint is the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy. 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. If the addition of a reminder app to standard care will result in a significant reduction of radiation toxicity, it could become a helpful tool for these patients.

Detailed description: The goal of this trial is to investigate whether the addition of a reminder app to standard care leads to a reduction of dermatitis and oral mucositis during radio(chemo)therapy for locally advanced squamous cell carcinoma of the head-and-neck (SCCHN).

This is a randomized, active-controlled, parallel-group trial, which will compare the following treatments of radiation dermatitis (primary endpoint) and oral mucositis in patients with SCCHN: Standard care supported by a reminder app (Arm A) vs. standard care alone (Arm B). The primary endpoint is to investigate the rate of patients experiencing grade ≥2 radiation dermatitis at 60 Gy of radiotherapy, the minimum planned total dose for all patients receiving definitive or adjuvant radiotherapy for locally advanced SCCHN with curative intention. In addition, the following endpoints will be evaluated: Radiation dermatitis grade ≥2 at the end of radiation treatment (EOT), radiation dermatitis grade ≥3 at 60 Gy and EOT, quality of life, pain, and radiation-induced oral mucositis grade ≥2 and grade ≥3 at 60 Gy and at EOT. According to sample size calculations, 80 patients are required per arm within the full analysis set. Taking into account that 5% of patients will not qualify for full analysis set, 168 patients should be randomized. The impact of the reminder app will be considered clinically relevant, if the rate of grade ≥2 radiation dermatitis can be reduced from 85% to 65%.

If the addition of a reminder app to standard care will result in a significant reduction of radiation dermatitis and oral mucositis, it could become a helpful tool for patients during radiotherapy of for SCCHN.

Eligibility criteria: Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the head-and-neck (SCCHN)
* Indication for definitive or adjuvant radio(chemo)therapy
* Possession of and ability to use a smart phone
* Age ≥18 years
* Written informed consent
* Capacity of the patient to contract

Exclusion Criteria:

* Nasopharynx cancer
* Pregnancy, Lactation
* Treatment with epidermal growth factor receptor (EGFR)-antibodies (either given or planned)
* Expected non-compliance

Primary outcomes:
measure: Rate of radiation dermatitis grade ≥2
timeFrame: until 60 Gy of radiotherapy
Secondary outcomes:
measure: Rate of radiation dermatitis grade ≥2
timeFrame: at the end of radiotherapy
measure: Rate of radiation dermatitis grade ≥3
timeFrame: at 60 Gy of radiotherapy and at the end of radiotherapy
measure: Pain score
timeFrame: prior to radiotherapy, weekly during radiotherapy, at 60 Gy and at the end of radiotherapy
measure: Rate of radiation-induced oral mucositis grade ≥2
timeFrame: at 60 Gy of radiotherapy and at the end of radiotherapy
measure: Rate of radiation-induced oral mucositis grade ≥3
timeFrame: at 60 Gy of radiotherapy and at the end of radiotherapy
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical Practice for Radiotherapy and Radiation Oncology
state: Niedersachsen
city: Lübeck
country: Germany
facility: Dept. of Radiation Oncology, University of Lübeck
state: Schleswig-Holstein
city: Barakaldo
country: Spain
facility: Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute
state: Vizcaya
city: Valencia
country: Spain
facility: Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe,
Study officials:
affiliation: Dept. of Radiation Oncology, University of Lübeck, Germany
name: Dirk Rades, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rades D, Narvaez CA, Doemer C, Janssen S, Olbrich D, Tvilsted S, Conde-Moreno AJ, Cacicedo J. Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis. Trials. 2020 May 25;21(1):424. doi: 10.1186/s13063-020-04307-0.