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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016453
Receipt No. R000019110
Official scientific title of the study The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
Date of disclosure of the study information 2015/02/09
Last modified on 2018/08/12

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Basic information
Official scientific title of the study The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
Title of the study (Brief title) The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Hematology and clinical oncology Oto-rhino-laryngology Radiology
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate beta-Hydroxy-beta-Methylbutyrate (HMB), Arginine, and Glutamine (AboundTM) in the prevention of chemoradiotherapy-induced oral mucositis in patients with head and neck cancer (ABLE)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Frequency of oral mucositis / stomatitis (functional/symptomatic) >=Grade 3
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of beta-Hydroxy-beta-Methylbutyrate (HMB), Arginine, and Glutamine (AboundTM)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key 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
Key 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
Target sample size 35

Research contact person
Name of lead principal investigator Tomoya Yokota
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Address 1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Email t.yokota@scchr.jp

Public contact
Name of contact person Tomoya Yokota
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Address 1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Homepage URL
Email t.yokota@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Pharma Valley Center
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 09 Day

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 21 Day
Anticipated trial start date
2015 Year 02 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Published
URL releasing results
Results
Other related information

Management information
Registered date
2015 Year 02 Month 05 Day
Last modified on
2018 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019110

Research Plan
Registered date File name
2018/08/12 アバンド_単相P2_プロトコールver1.4 20160411.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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