UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016453 |
|---|---|
| Receipt number | R000019110 |
| Scientific Title | 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 17:13:23 |
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Basic information
Public title
The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
Acronym
The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
Scientific Title
The phase II study of AboundTM against oral mucositis induced by chemoradiotherapy for head and neck cancer patients
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomoya Yokota |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
Address
1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
t.yokota@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Yokota |
Organization
Shizuoka Cancer Center
Division name
Division of Gastrointestinal Oncology
Zip code
Address
1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka 411-8777, Japan
TEL
055-989-5222
Homepage URL
t.yokota@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 21 | Day |
Date of IRB
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
Other
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
Value
https://center6.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 | |
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| Registered date | File name |
