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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003012
Receipt No. R000003648
Scientific Title Gabapentin for the treatment of pain related to radiation induced mucositis in patients with head and neck cancer
Date of disclosure of the study information 2010/02/01
Last modified on 2019/05/14

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Basic information
Public title Gabapentin for the treatment of pain related to radiation induced mucositis in patients with head and neck cancer
Acronym Gabapentin for the treatment of pain related to radiation induced mucositis in patients with head and neck cancer
Scientific Title Gabapentin for the treatment of pain related to radiation induced mucositis in patients with head and neck cancer
Scientific Title:Acronym Gabapentin for the treatment of pain related to radiation induced mucositis in patients with head and neck cancer
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effect and efficacy of gabapentin for the treatment of pain related to radiation-induced mucositis in patients with head and neck cancer treated with radiation or chemoradiation therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The maximum of visual analogue scale (VAS) during the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 standard of care
Interventions/Control_2 start gabapentin on the first day of radiation therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. PS (ECOG): 0-2
2. Histologically diagnosed malignant tumor
3. Primary site: oral cavity, nasopharynx, oropharynx, hypopharyns, larynx
4. Head and neck cancer patients who are to be treated with radiation or chemoradiation therapy
5. Dose of radiation: more than 60Gy
6. Patients provided written informed consent
7. Chemothrapy: cisplatin or cisplatin+fluorouracil
Key exclusion criteria 1. malignant tumors of other organs
2. women who are pregnant or breast feeding
3. with mental disorder
4. recieve the systemic therapy of steroid continuously
5. inadequately controlled diabetes
6. have the history of miocardial or cerebral infarction within 3 months
7. with sever active co-mobidity (COPD, interstitial pneumonitis, angina pectoris and so on)
8. a previous history of a severe drug hypersensitivity against an anticonvulsant agent
9. moderate and severe renal dysfunction (creatinine clearance<60mL/min.), severe liver dysfunction (T-Bil>2.0mg/dL)
10. severe infection with systemic aaministration
11. use of anticonvulsant or antidepressant drug
12. use of pain killer before starting radiation therapy
13. visual analogue scale (VAS): over 4.0 before starting radiation therapy
Target sample size 22

Research contact person
Name of lead principal investigator
1st name Naomi
Middle name
Last name Kiyota
Organization Kobe University Graduate School of Medecine
Division name Medical Oncology and Hematology
Zip code 650-0017
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5111
Email nkiyota@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Kataoka
Organization Kobe University Hospital
Division name Oral and Maxillofacial Surgery
Zip code 650-0017
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL 078-382-5111
Homepage URL
Email tkataoka@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization Kobe University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe University Hospital
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel 078-382-5111
Email chiken@med.kobe-u.ac.jp

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
2010 Year 02 Month 01 Day

Related information
URL releasing protocol none
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/26992271
Number of participants that the trial has enrolled 22
Results
Twenty-two eligible patients were randomly assigned to standard pain control (SPC) or SPC+gabapentin (G) (n=11 each). Median maximum VAS scores, median total dose of opioids at maximum VAS and total dose of opioids at 4 weeks after CRT tended to be higher in the SPC+G arm (47 in SPC vs. 74 in SPC+G, p=0.517; 215 mg vs. 745.3 mg, p=0.880; and 1260 mg vs. 1537.5 mg, p=0.9438, respectively), without significance. QOL analysis showed significantly worse scores in the SPC+G arm for weight gain (p=0.005). 
Results date posted
2019 Year 05 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age was 61 years. All patients were Stage III, IVA and IVB. Twelve patients were treated in the locally advanced setting and 10 in the postoperative setting.
Participant flow
From April 2010 to October 2011, 22 eligible patients undergoing concurrent CRT (cisplatin+RT) for head and neck malignancies at Kobe University Hospital were randomly assigned to receive standard pain control (SPC) (n=11) or SPC plus gabapentin (n=11). One patient in SPC+G was terminated because of total laryngectomy.
Adverse events
As toxicities specific to gabapentin, we observed somnolence in two and allergic skin reaction in one. One patient experienced grade 2 somnolence and required a dose reduction to 300 mg/day. One patient developed a persistent grade 2 follicular skin rash during treatment with gabapentin; the rash resolved after treatment with antihistamine and topical steroid, and the patient was able to continue gabapentin without a dose reduction during the study period.
Outcome measures
Median maximum VAS score, the primary endpoint, tended to be higher in the SPC+G arm, albeit without statistical significance (47 in SPC vs. 74 in SPC+G; p=0.552). From baseline to 4 weeks after the treatment, there was also no statistical difference in VAS scores at each time point between two arms.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 01 Month 20 Day
Date of IRB
2010 Year 02 Month 19 Day
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2013 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 11 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003648

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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