head and neck cancer
Conditions
Interventions
Intake of beta-Hydroxy-beta-Methylbutyrate (HMB), Arginine, and Glutamine (AboundTM)
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 pharyngeal space or oral space (v) Be to receive cisplatin-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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of oral mucositis / stomatitis (functional/symptomatic) >=Grade 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of oral mucositis / stomatitis (clinical exam)>=Grade3 Duration of oral mucositis / stomatitis (clinical exam and functional/symptomatic) >=Grade 3 Frequency of oral mucositis / stomatitis (clinical exam and functional/symptomatic) >=Grade2 Duration of oral mucositis / stomatitis (clinical exam and functional/symptomatic) >=Grade 2 How many days oral intake is feasible after initiation of chemoradiotherapy Frequency of use of percutaneous endoscopic gastrostomy (PEG) for nutrition support 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
Contacts
Public ContactTomoya Yokota
Shizuoka Cancer Center Division of Gastrointestinal Oncology
Outcome results
None listed