RAdiotherapy RElated Skin Toxicity: a Reminder App to Reduce Radiation Dermatitis Rates in Patients with Head-and-Neck Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiation Dermatitis
- Sponsor
- University Hospital Schleswig-Holstein
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Rate of radiation dermatitis grade ≥2
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Prof Dirk Rades
Chair of the Department of Radiation Oncology
University Hospital Schleswig-Holstein
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- 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)