Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003684
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
1999-11-01
Brief Title:
Theophylline in Treating Cancer Patients With Shortness of Breath
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2020-04
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 Theophylline may help to relieve shortness of breath in patients who have cancer It is not yet known whether theophylline is more effective than no further treatment for shortness of breath
PURPOSE Randomized phase III trial to determine the effectiveness of theophylline in treating shortness of breath in patients who have cancer
PURPOSE Randomized phase III trial to determine the effectiveness of theophylline in treating shortness of breath in patients who have cancer
Detailed Description:
OBJECTIVES I Determine whether theophylline will improve the dyspnea rating of patients with cancer who are short of breath and have evidence of respiratory muscle weakness II Determine whether this drug will improve the ability to perform daily activities in this group of patients III Determine whether this drug will improve objective measures of lung function eg FEV-1 FVC and maximum inspiratory pressure in these patients IV Determine whether the serum theophylline level is related to the magnitude of the effect that is observed in this patient population V Determine whether this drug will improve a global rating of quality of life in this patient group
OUTLINE This is a randomized double blind multicenter study Patients are stratified according to those who can complete a 6 minute walking test versus those who cannot Patients receive either oral theophylline or placebo once daily for 3 days In the absence of dose limiting toxicity DLT patients receive an increased dose for an additional 4 days In the presence of DLT patients receive a decreased dose or treatment is stopped Following completion of the 7 day study period patients may be given the option to continue on active drug or placebo for 1 additional month unless toxic side effects develop Quality of life is assessed on days 1 and 8 and at the end of the additional 1 month period
PROJECTED ACCRUAL A total of 60 patients 30 in each arm will be accrued for this study
OUTLINE This is a randomized double blind multicenter study Patients are stratified according to those who can complete a 6 minute walking test versus those who cannot Patients receive either oral theophylline or placebo once daily for 3 days In the absence of dose limiting toxicity DLT patients receive an increased dose for an additional 4 days In the presence of DLT patients receive a decreased dose or treatment is stopped Following completion of the 7 day study period patients may be given the option to continue on active drug or placebo for 1 additional month unless toxic side effects develop Quality of life is assessed on days 1 and 8 and at the end of the additional 1 month period
PROJECTED ACCRUAL A total of 60 patients 30 in each arm will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000066786 | OTHER | PDQ | None |
| CAN-NCIC-SC14 | OTHER | None | None |