Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022373
Status:
UNKNOWN
Last Update Posted:
2014-10-15
First Post:
2001-08-10
Brief Title:
Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multinational Multicenter Double-Blind Placebo-Controlled Randomized Phase III Clinical Trial to Determine the Efficacy and Safety of IB-367 Rinse in Reducing the Severity of Oral Mucositis in Patients Receiving Radiotherapy for Head and Neck Malignancy
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Iseganan hydrochloride may be effective in preventing or lessening oral mucositis in patients who are receiving radiation therapy for head and neck cancer It is not yet known if iseganan hydrochloride is effective in preventing oral mucositis
PURPOSE Randomized phase III trial to determine the effectiveness of iseganan hydrochloride in preventing oral mucositis in patients who are receiving radiation therapy for head and neck cancer
PURPOSE Randomized phase III trial to determine the effectiveness of iseganan hydrochloride in preventing oral mucositis in patients who are receiving radiation therapy for head and neck cancer
Detailed Description:
OBJECTIVES I Compare the efficacy and safety of iseganan HCl oral solution vs placebo in patients undergoing radiotherapy with or without chemotherapy for head and neck cancer II Compare the effects of these treatments on mouth pain ability to swallow weight loss and the distribution of oral mucositis in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to radiotherapy conventional fractionating radiotherapy vs hyperfractionating or concurrent boost radiotherapy and concurrent chemotherapy yes vs no Patients are randomized to 1 of 3 arms Arm I Patients rinse with iseganan HCl oral solution 6 times daily Treatment continues for the duration of the scheduled radiotherapy Arm II Patients rinse with oral placebo 6 times daily Treatment continues for the duration of the scheduled radiotherapy Arm III Patients receive standard-of-care supportive treatment Oral cavity pain ability to swallow and weight loss are assessed twice weekly and on follow-up days 28 and 56 Patients are followed on days 28 and 56
PROJECTED ACCRUAL A total of 504 patients 252 for arm I 168 for arm II and 84 for arm III will be accrued for this study
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to radiotherapy conventional fractionating radiotherapy vs hyperfractionating or concurrent boost radiotherapy and concurrent chemotherapy yes vs no Patients are randomized to 1 of 3 arms Arm I Patients rinse with iseganan HCl oral solution 6 times daily Treatment continues for the duration of the scheduled radiotherapy Arm II Patients rinse with oral placebo 6 times daily Treatment continues for the duration of the scheduled radiotherapy Arm III Patients receive standard-of-care supportive treatment Oral cavity pain ability to swallow and weight loss are assessed twice weekly and on follow-up days 28 and 56 Patients are followed on days 28 and 56
PROJECTED ACCRUAL A total of 504 patients 252 for arm I 168 for arm II and 84 for arm III will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016042 | NIH | None | None |
| UCLA-0008049 | None | None | None |
| IBP-PG-015 | None | None | None |
| NCI-G01-2001 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016042 |