A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer

Not Applicable

Terminated

• Conditions: Radiation Dermatitis; Radiation-induced Oral Mucositis
• Interventions: Device: mobile application (reminder app)

• Registration Number: NCT04110977
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Study Start: 2020-10-10
• Primary Completion: 2022-01-17
• Status Verified: 2022-12
• Study Completion: 2022-12-05
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care supported by a Reminder App (Arm A)	mobile application (reminder app)	Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy.
Standard Care alone (Arm B)	mobile application (reminder app)	Treatment with Standard Care alone, starting at the beginning of radiotherapy.

Primary Outcome Measures

Name	Time	Method
Rate of radiation dermatitis grade ≥2	until 60 Gy of radiotherapy	at least moderate radiation-induced skin toxicity such as erythema and desquamation

Secondary Outcome Measures

Name	Time	Method
Rate of radiation-induced oral mucositis grade ≥2	at 60 Gy of radiotherapy and at the end of radiotherapy	at least moderate radiation-induced inflammation of the oral mucosa
Rate of radiation-induced oral mucositis grade ≥3	at 60 Gy of radiotherapy and at the end of radiotherapy	severe radiation-induced inflammation of the oral mucosa
Rate of radiation dermatitis grade ≥2	at the end of radiotherapy	at least moderate radiation-induced skin toxicity such as erythema and desquamation
Rate of radiation dermatitis grade ≥3	at 60 Gy of radiotherapy and at the end of radiotherapy	severe radiation-induced skin toxicity such as erythema and desquamation
Pain score	prior to radiotherapy, weekly during radiotherapy, at 60 Gy and at the end of radiotherapy	Pain within the radiation fields measured with a self-rating analogue scale ranging from 0 (no pain) to 10 (maximum pain) points; higher values represent worse outcomes.

Trial Locations

Locations (4)

Medical Practice for Radiotherapy and Radiation Oncology; 🇩🇪 Hannover, Niedersachsen, Germany

Dept. of Radiation Oncology, University of Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute; 🇪🇸 Barakaldo, Vizcaya, Spain

Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe,; 🇪🇸 Valencia, Spain