UMIN ID: UMIN000001048
Registered date:01/03/2008
The multicenter phase II study of opioid based pain control program for head and neck cancer patients recieving chemoradiotherapy
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Head and neck cancer |
| Date of first enrollment | 2008/03/01 |
| Target sample size | 110 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Opioid based pain control program |
Outcome(s)
| Primary Outcome | The frequency of treatment interruption caused by severe stmatitis or mucocitis |
|---|---|
| Secondary Outcome | the rate of completion of radiotherapy |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1 women who are pregnant or breast feeding 2 with mental disorder 3 recieve the systemic therapy of steroid continuously 4 have the history of Miocardial infarction within 3 months 5 recieve the opioid therapy for cancer pain 6 with sever active co-mobidity (COPD, interstitial pneumonitis, angina pectoris and so on) 7 with severe infectious disease 8 do not agree with constructing PEG 9 with collagenosis |
Related Information
| Primary Sponsor | Study for establishment of prevention and therapy of oral complication induced by cancer treatment |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant-in-aid for cancer research |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Sadamoto Zenda |
| Address | 6-5-1 kashiwanoha Kashiwa city chiba, Japan Japan |
| Telephone | 04-7133-1111 |
| szenda@east.ncc.go.jp | |
| Affiliation | National Cancer Center Hospital East Radiation Oncology Division |
| scientific contact | |
| Name | Masao |
| Address | 5-1-1 Tsukiji Chuo-ku Tokyo, Japan Japan |
| Telephone | 0 |
| Affiliation | National Cancer Center Hospital Head and Neck Surgery |