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

RAdiotherapy RElated Skin Toxicity: A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Radiation Dermatitis; Radiation-induced Oral Mucositis
• Intervention / Treatment: Device: mobile application (reminder app)

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 Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dirk Rades, Professor; Phone Number: 45400 +49 451 500; Email: dirk.rades@uksh.de
• Study Contact Backup: Name: Carlos A Narvaez; Phone Number: +49 451 500; Email: carlos.narvaez@uksh.de

Study Locations

• Germany
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30449
      • Recruiting
      • Medical Practice for Radiotherapy and Radiation Oncology
      • Contact: Stefan Janssen, Priv.-Doz.; Email: st-janssen@gmx.net
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Recruiting
      • Dept. of Radiation Oncology, University of Lübeck
      • Contact: Dirk Rades, Professor; Phone Number: 45400 +49 451 500; Email: dirk.rades@uksh.de
      • Contact: Carlos A Narvaez; Phone Number: 45401 +49 451 500; Email: carlos.narvaez@uksh.de
• Spain
  • Valencia, Spain
    • Not yet recruiting
    • Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe,
    • Contact: Antonio J Conde, MD; Email: antoniojconde@gmail.com
  • Vizcaya
    • Barakaldo, Vizcaya, Spain
      • Not yet recruiting
      • Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute
      • Contact: Jon Cacicedo, MC; Email: JON.CACICEDOFERNANDEZBOBADILLA@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Care supported by a Reminder App (Arm A); Treatment with Standard Care supported by a Reminder App, starting at the beginning of radiotherapy.	Device: mobile application (reminder app); This app will remind the patients four times a day to perform skin and mouth care. Instructions are given how to properly perform skin and mouth care. The patients may postpone each required care procedure for up to 2 hours. Finally, the patients are asked to state for each procedure whether or not they performed it. To increase the patients' motivation, they will earn points for each successfully performed care procedure.
Active Comparator: Standard Care alone (Arm B); Treatment with Standard Care alone, starting at the beginning of radiotherapy.	Device: mobile application (reminder app); This app will remind the patients four times a day to perform skin and mouth care. Instructions are given how to properly perform skin and mouth care. The patients may postpone each required care procedure for up to 2 hours. Finally, the patients are asked to state for each procedure whether or not they performed it. To increase the patients' motivation, they will earn points for each successfully performed care procedure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of radiation dermatitis grade ≥2	at least moderate radiation-induced skin toxicity such as erythema and desquamation	at the end of radiotherapy
Rate of radiation dermatitis grade ≥3	severe radiation-induced skin toxicity such as erythema and desquamation	at 60 Gy of radiotherapy and at the end of radiotherapy
Pain score	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.	prior to radiotherapy, weekly during radiotherapy, at 60 Gy and at the end of radiotherapy
Rate of radiation-induced oral mucositis grade ≥2	at least moderate radiation-induced inflammation of the oral mucosa	at 60 Gy of radiotherapy and at the end of radiotherapy
Rate of radiation-induced oral mucositis grade ≥3	severe radiation-induced inflammation of the oral mucosa	at 60 Gy of radiotherapy and at the end of radiotherapy

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Dirk Rades, Professor, Dept. of Radiation Oncology, University of Lübeck, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: radiotherapy; Head-and-neck cancer; radiation dermatitis; oral mucositis; reminder app
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Radiation Injuries; Head and Neck Neoplasms; Dermatitis; Mucositis; Radiodermatitis; Stomatitis
• Other Study ID Numbers: RAREST-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No