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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

Tracking Information
First Submitted Date  ICMJE September 27, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE October 10, 2020
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
radiation dermatitis grade ≥2 [ Time Frame: until 60 Gy of radiotherapy ]
at least moderate radiation-induced skin toxicity such as erythema and desquamation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • 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
  • 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
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • radiation dermatitis grade ≥2 [ Time Frame: at the end of radiotherapy ]
    at least moderate radiation-induced skin toxicity such as erythema and desquamation
  • 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
  • Pain score [ Time Frame: prior to radiotherapy, weekly during radiotherapy, at 60 Gy and at the end of radiotherapy ]
    pain score (0= no pain, 10= maximum pain) within the radiation fields
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer
Official Title  ICMJE RAdiotherapy RElated Skin Toxicity: A Reminder App to Reduce Radiation Dermatitis Rates in Patients With Head-and-Neck Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, active-controlled, parallel-group trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Radiation Dermatitis
  • Radiation-induced Oral Mucositis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: mobile application (reminder app)
  • Active Comparator: Standard Care alone (Arm B)
    Treatment with Standard Care alone, starting at the beginning of radiotherapy.
    Intervention: Device: mobile application (reminder app)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2019)
168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dirk Rades, Professor +49 451 500 ext 45400 dirk.rades@uksh.de
Contact: Carlos A Narvaez +49 451 500 carlos.narvaez@uksh.de
Listed Location Countries  ICMJE Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04110977
Other Study ID Numbers  ICMJE RAREST-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prof. Dirk Rades, MD, University Hospital Schleswig-Holstein
Study Sponsor  ICMJE University Hospital Schleswig-Holstein
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dirk Rades, Professor Dept. of Radiation Oncology, University of Lübeck, Germany
PRS Account University Hospital Schleswig-Holstein
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP