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

NCT04110977 | Terminated

• 1 other identifier: RAREST-02
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

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.

Conditions

Radiation Dermatitis; Radiation-induced Oral Mucositis

Keywords

Head-and-neck cancer; radiotherapy; radiation dermatitis; oral mucositis; reminder app

Outcome Measures

Primary Outcomes (1)

• Rate of radiation dermatitis grade ≥2

  at least moderate radiation-induced skin toxicity such as erythema and desquamation

  until 60 Gy of radiotherapy

Secondary Outcomes (5)

• Rate of radiation dermatitis grade ≥2

  at the end of radiotherapy

• Rate of radiation dermatitis grade ≥3

  at 60 Gy of radiotherapy and at the end of radiotherapy

• Pain score

  prior to radiotherapy, weekly during radiotherapy, at 60 Gy and at the end of radiotherapy

• Rate of radiation-induced oral mucositis grade ≥2

  at 60 Gy of radiotherapy and at the end of radiotherapy

• Rate of radiation-induced oral mucositis grade ≥3

  at 60 Gy of radiotherapy and at the end of radiotherapy

Study Arms (2)

Standard Care supported by a Reminder App (Arm A)

EXPERIMENTAL

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

Device: mobile application (reminder app)

Standard Care alone (Arm B)

ACTIVE COMPARATOR

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

Device: mobile application (reminder app)

Interventions

mobile application (reminder app) DEVICE

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.

Standard Care alone (Arm B); Standard Care supported by a Reminder App (Arm A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (4)

Medical Practice for Radiotherapy and Radiation Oncology

Hanover, Lower Saxony, 30449, Germany

Location

Dept. of Radiation Oncology, University of Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe,

Valencia, Valencia, Spain

Location

Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute

Barakaldo, Vizcaya, Spain

Location

Related Publications (1)

• 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.

  PMID: 32450921 DERIVED

MeSH Terms

Conditions

Radiodermatitis; Head and Neck Neoplasms; Stomatitis

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dirk Rades, Professor

  Dept. of Radiation Oncology, University of Lübeck, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Radiation Oncology

Model Details: randomized, active-controlled, parallel-group trial

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: October 10, 2020
• Primary Completion: January 17, 2022
• Study Completion: December 5, 2022
• Last Updated: January 15, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); ES (2)