The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
- Conditions
- head and neck cancer
- Registration Number
- JPRN-UMIN000016453
- Lead Sponsor
- Shizuoka Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
i. Opioid use before initiation of chemoradiotherapy ii. Use of AboundTM before initiation of chemoradiotherapy iii. Patients who will receive palliative chemoradiotherapy iv. Serious comorbidities include the following: a. Renal failure b. Disseminated intravascular coagulation c. Acute thrombocytopenia d. Chronic obstructive pulmonary disease e. Interstitial pneumonia f. Severe heart disease, such as ischemic heart disease and arrhythmia v. Women who are pregnant, contemplating pregnancy or amid breast-feeding. vi. Mental disorders which is considered inappropriate for inclusion in the study. vii. Continuous systemic treatment with corticosteroids viii. Signs of acute bacterial or fungus infection ix. Protein intake restriction x. Patients who are taking supplement or drugs containing Arginine or Glutamine, and who will continue to take them throughout the chemotherapy xi. Hypersensitivity to the element of AboundTM xii. Unable to take AboundTM per oral or per PEG xiii. Any other cases who are regarded as inadequate for study enrollment by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method