UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003012 |
|---|---|
| Receipt number | 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 01:41:47 |
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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
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
tkataoka@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003648
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