The phase II study of oral care program for head and neck cancer patients treated with chemoradiotherapy
Phase 2
- Conditions
- Head and neck cancer
- Registration Number
- JPRN-UMIN000006660
- Lead Sponsor
- Shizuoka Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of oral mucositis / stomatitis (clinical exam and functional/symptomatic) >Grade3
- Secondary Outcome Measures
Name Time Method 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