Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036881
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2002-05-13
Brief Title:
Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Double-Blind Placebo-Controlled Randomized Comparison Of Zinc Sulfate Versus Placebo For The Prevention Of Altered Taste In Patients With Head And Neck Cancer During Radiation
Status:
COMPLETED
Status Verified Date:
2016-07
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 It is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer
PURPOSE Randomized phase III trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer
PURPOSE Randomized phase III trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer
Detailed Description:
OBJECTIVES
Determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy
Determine whether this drug decreases the overall incidence of altered taste in these patients
Determine whether this drug results in fewer radiotherapy treatment interruptions in these patients
Assess the quality of life of patients treated with this drug
Determine the toxic effects of this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to planned radiotherapy dose less than 6000 cGy vs at least 6000 cGy estimated amount of oral mucosa in the radiation field 60 or less vs more than 60 age under 50 vs 50 and over concurrent chemotherapy yes vs no and smoking yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy
Arm II Patients receive oral placebo 3 times daily beginning the first week of radiotherapy
Treatment in both arms continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity
Quality of life is assessed at baseline weekly during treatment and then at 1 2 3 and 6 months after the completion of treatment
Patients are followed at 1 2 3 and 6 months after the completion of treatment and then every 6 months for 1 year
Determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy
Determine whether this drug decreases the overall incidence of altered taste in these patients
Determine whether this drug results in fewer radiotherapy treatment interruptions in these patients
Assess the quality of life of patients treated with this drug
Determine the toxic effects of this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to planned radiotherapy dose less than 6000 cGy vs at least 6000 cGy estimated amount of oral mucosa in the radiation field 60 or less vs more than 60 age under 50 vs 50 and over concurrent chemotherapy yes vs no and smoking yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy
Arm II Patients receive oral placebo 3 times daily beginning the first week of radiotherapy
Treatment in both arms continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity
Quality of life is assessed at baseline weekly during treatment and then at 1 2 3 and 6 months after the completion of treatment
Patients are followed at 1 2 3 and 6 months after the completion of treatment and then every 6 months for 1 year
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 |
|---|---|---|---|
| CDR0000069337 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02465 | REGISTRY | None | None |
| NCI-P02-0224 | None | None | None |