Head and neck cancer
Conditions
Interventions
1. Education program for co-medical who evaluate oral mucositis 2. Oral care protocol intervention 2-1 Dental evaluation before chemoradiotherapy 2-2 Education for patients before chemoradiotherapy
treatment
Sponsors
Shizuoka Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (i) Age 20 - 75 years (ii) Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 (iii) Patients with head and neck cancer who will undergo definitive chemoradiotherapy or postoperative adjuvant chemoradiotherapy (iv) Be to receive over 50 Gy of irradiation for oral space (v) Be to receive platinum-based chemoradiotherapy (vi) Adequate hematological, liver and renal functions. (vii) Sufficient eating ability, normalcy of diet in performance status scale for head and neck cancer patients (PSSHN)≥50 (viii) Be able to keep water inside the oral cavity (ix) Absence of oral mucositis / stomatitis (clinical exam and functional/symptomatic) and dry mouth evaluated by CTCAE version 3.0 (x) Written informed consent was obtained from each patient
Exclusion criteria
Exclusion criteria: i. Women who are pregnant, contemplating pregnancy or amid breast-feeding. ii. Mental disorders which is considered inappropriate for inclusion in the study. iii. Continuous systemic treatment with corticosteroids iv. Introduction of opioid v. Serious comorbidities include the following: a. Renal failure b. Disseminated intravascular coagulation c. Acute thrombocytopenia d. Chronic obstructive pulmonary disease e. pulmonary fibrosis or interstitial pneumonia f. Severe heart disease, such as ischemic heart disease and arrhythmia vi. Signs of acute bacterial or fungus infection vii. Previous history of radiotherapy in the oral cavity viii. Patients who will receive palliative chemoradiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of oral mucositis / stomatitis (clinical exam and functional/symptomatic) >Grade3 | — |
Secondary
| Measure | Time frame |
|---|---|
| How many days oral intake is feasible after initiation of chemoradiotherapy Frequency of use of percutaneous endoscopic gastrostomy (PEG) for nutrition support Duration of oral mucositis / stomatitis (clinical exam and functional/symptomatic) Frequencies of treatment interruption due to oral mucositis / stomatitis (clinical exam and functional/symptomatic) When opioid is introduced for pain control after initiation of chemoradiotherapy Maximum dose of opioid used Adverse events rather than oral mucositis | — |
Countries
Japan
Outcome results
None listed