A Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer (RAREST-02)

University Hospital Schleswig-Holstein (UKSH)

Status: Terminated

Conditions: Radiation-induced Oral Mucositis; Radiation Dermatitis

Treatments: Device: mobile application (reminder app)

Study type: Interventional

Funder types: Other

Identifiers

NCT04110977

RAREST-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard Care supported by a Reminder App (Arm A)

Experimental group

Description:

Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy.

Treatment:

Device: mobile application (reminder app)

Standard Care alone (Arm B)

Active Comparator group

Description:

Treatment with Standard Care alone, starting at the beginning of radiotherapy.

Treatment:

Device: mobile application (reminder app)