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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006660
Receipt No. R000007869
Scientific Title The phase II study of oral care program for head and neck cancer patients treated with chemoradiotherapy
Date of disclosure of the study information 2011/12/01
Last modified on 2016/02/15

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Basic information
Public title The phase II study of oral care program for head and neck cancer patients treated with chemoradiotherapy
Acronym The phase II study of oral care program for head and neck cancer patients treated with chemoradiotherapy
Scientific Title The phase II study of oral care program for head and neck cancer patients treated with chemoradiotherapy
Scientific Title:Acronym The phase II study of oral care program for head and neck cancer patients treated with chemoradiotherapy
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Medicine in general Gastroenterology Oto-rhino-laryngology
Radiology Oral surgery Dental medicine
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate an oral care protocol intervention in the prevention of chemoradiotherapy-induced oral mucositis in patients with head and neck cancer
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 (clinical exam and functional/symptomatic) >Grade3
Key secondary outcomes 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

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
Behavior,custom
Interventions/Control_1 1. Education program for co-medical who evaluate oral mucositis
2. Oral care protocol intervention
2-1 Dental evaluation before chemoradiotherapy
2-2 Education for patients before chemoradiotherapy
2-3 Oral care during chemoradiotherapy
2-4 Evaluation of oral mucositis by co-medical
2-5 Cooperation between hospital treatment and outpatients' treatment
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 oral space
(v) Be to receive platinum-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)&#8805;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. 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 &#64257;brosis 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
Target sample size 120

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shizuoka Cancer Center
Division name Division of Gastrointestinal Oncology
Zip code
Address 1007 Shimonagakubo Nagaizumi Sunto-gun, Shizuoka 411-8777, Japan
TEL
Homepage URL
Email

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 静岡県立静岡がんセンター(静岡県)、愛知県がんセンター中央病院(愛知県)、独立行政法人 国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2011 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 05 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 02 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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