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

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ClinicalTrials.gov Identifier: NCT04110977
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dirk Rades, MD, 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.

Condition or disease Intervention/treatment Phase
Radiation Dermatitis Radiation-induced Oral Mucositis Device: mobile application (reminder app) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, active-controlled, parallel-group trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RAdiotherapy RElated Skin Toxicity: A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Rate of radiation dermatitis grade ≥2 [ Time Frame: until 60 Gy of radiotherapy ]
    at least moderate radiation-induced skin toxicity such as erythema and desquamation


Secondary Outcome Measures :
  1. Rate of radiation dermatitis grade ≥2 [ Time Frame: at the end of radiotherapy ]
    at least moderate radiation-induced skin toxicity such as erythema and desquamation

  2. Rate of radiation dermatitis grade ≥3 [ Time Frame: at 60 Gy of radiotherapy and at the end of radiotherapy ]
    severe radiation-induced skin toxicity such as erythema and desquamation

  3. Pain score [ Time Frame: 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.

  4. Rate of radiation-induced oral mucositis grade ≥2 [ Time Frame: at 60 Gy of radiotherapy and at the end of radiotherapy ]
    at least moderate radiation-induced inflammation of the oral mucosa

  5. Rate of radiation-induced oral mucositis grade ≥3 [ Time Frame: at 60 Gy of radiotherapy and at the end of radiotherapy ]
    severe radiation-induced inflammation of the oral mucosa



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110977


Contacts
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Contact: Dirk Rades, Professor +49 451 500 ext 45400 dirk.rades@uksh.de
Contact: Carlos A Narvaez +49 451 500 carlos.narvaez@uksh.de

Locations
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Germany
Medical Practice for Radiotherapy and Radiation Oncology Recruiting
Hannover, Niedersachsen, Germany, 30449
Contact: Stefan Janssen, Priv.-Doz.       st-janssen@gmx.net   
Dept. of Radiation Oncology, University of Lübeck Recruiting
Lübeck, Schleswig-Holstein, Germany, 23562
Contact: Dirk Rades, Professor    +49 451 500 ext 45400    dirk.rades@uksh.de   
Contact: Carlos A Narvaez    +49 451 500 ext 45401    carlos.narvaez@uksh.de   
Spain
Department of Radiation Oncology, Cruces University Hospital/ Biocruces Health Research Institute Not yet recruiting
Barakaldo, Vizcaya, Spain
Contact: Jon Cacicedo, MC       JON.CACICEDOFERNANDEZBOBADILLA@osakidetza.eus   
Dept. of Radiation Oncology, Hospital Universitario y Politecnico La Fe, Not yet recruiting
Valencia, Spain
Contact: Antonio J Conde, MD       antoniojconde@gmail.com   
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Investigators
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Principal Investigator: Dirk Rades, Professor Dept. of Radiation Oncology, University of Lübeck, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dirk Rades, MD, Chair of the Department of Radiation Oncology, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT04110977    
Other Study ID Numbers: RAREST-02
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein:
Head-and-neck cancer
radiotherapy
radiation dermatitis
oral mucositis
reminder app
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Skin Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Radiation Injuries
Wounds and Injuries