Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003139
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
1999-11-01
Brief Title:
Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Study to Test the Efficacy of the Prophylactic Use of Oral Pilocarpine to Reduce Hyposalivation and Mucositis Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy It is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer
PURPOSE Randomized double-blinded phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer
PURPOSE Randomized double-blinded phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer
Detailed Description:
OBJECTIVES I Determine whether prophylactic use of pilocarpine can shelter unstimulated and stimulated whole salivary flow in patients with head and neck cancer II Determine whether prophylactic use of pilocarpine can moderate xerostomia in these patients III Determine whether prophylactic use of pilocarpine can reduce the grade and duration of radiation induced mucositis in these patients IV Evaluate quality of life outcomes between patients receiving pilocarpine versus placebo V Evaluate the impact of xerostomia on patients receiving irradiation to the head and neck
OUTLINE This is a randomized double blind study Patients receive a central axis midplane dose of radiotherapy five days per week over 6 to 7 weeks Oral pilocarpine or placebo is administered beginning 3 days prior to radiotherapy one tablet four times per day for three months A tablet will be taken 45-60 minutes before radiotherapy After three months and after a 3-4 day rest period all patients receive non blinded pilocarpine for an additional three month period Patients are followed at weeks 4 13 and 26 after the start of radiotherapy
PROJECTED ACCRUAL A total of 244 patients will be accrued 122 per treatment arm
OUTLINE This is a randomized double blind study Patients receive a central axis midplane dose of radiotherapy five days per week over 6 to 7 weeks Oral pilocarpine or placebo is administered beginning 3 days prior to radiotherapy one tablet four times per day for three months A tablet will be taken 45-60 minutes before radiotherapy After three months and after a 3-4 day rest period all patients receive non blinded pilocarpine for an additional three month period Patients are followed at weeks 4 13 and 26 after the start of radiotherapy
PROJECTED ACCRUAL A total of 244 patients will be accrued 122 per treatment arm
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 |
|---|---|---|---|
| NCI-P97-0121 | None | None | None |
| CDR0000065912 | None | None | None |