Pulmonary ComplicationsPhase 3NCT00003684
Theophylline in Treating Cancer Patients With Shortness of Breath
A Phase 3 study testing theophylline and quality-of-life assessment in people with Pulmonary Complications and Quality of Life, run by NCIC Clinical Trials Group at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 120 years
- Conditions the study is for
- Pulmonary Complications, Quality of Life, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- theophylline and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 4 sitesCanada
- Study dates
- 24 Mar 1998to 15 Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically or cytologically proven diagnosis of cancer FEV-1/FVC at least 80% of predicted OR FEV-1/FVC less than 80% AND improvement in FEV-1 less than 15% after using a bronchodilator Maximum inspiratory pressure no greater than -50 cm of water Oximetry at least 90% Rating of dyspnea "moderate" or "severe" on verbal rating scale (VRS) of "none, mild, moderate, or severe" to describe "usual breathlessness" when walking over the past 24 hours Score for pain of "none" or "mild" on a VRS of "none, mild, moderate, or severe" for "unusual pain" over the past 24 hours
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Greater than 10 days Hematopoietic: Hemoglobin at least 8.5 g/dL Hepatic: AST/ALT no greater than 2 times upper limit of normal (ULN) No liver disease Renal: Creatinine no greater than 2 times ULN No kidney disease Cardiovascular: No acute congestive heart failure Greater than 3 months since prior myocardial infarction No coronary artery disease where cardiac stimulation might prove harmful (i.e., no unstable angina) No uncontrolled hypertension Pulmonary: See Disease Characteristics Other: Folstein Mini-Mental Status Exam score of at least 24 Able (i.e., sufficiently fluent) and willing to complete quality of life questionnaire and other assessments in either English or French No history of clinically significant allergy or intolerance to theophylline, aminophylline, or other methylxanthines No active peptic ulcer disease No uncontrolled hyperthyroidism
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 14 days since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 months since prior initiation of hormonal therapy Hormones as appetite stimulant allowed if received for more than 2 weeks No concurrent oral contraceptives Concurrent steroids allowed if taken for at least 1 week prior to study Concurrent inhaled or oral corticosteroids allowed if taken for at least 1 week prior to study No concurrent initiation of a new hormonal manipulation Radiotherapy: At least 28 days since prior radiotherapy that includes the lung in the treatment field No concurrent radiotherapy that includes the lung in the treatment field Surgery: Not specified Other: No concurrent digitalis glycosides, lithium, coumarin anticoagulants, other xanthines, cimetidine, quinolone antibiotics (e.g, ciprofloxacin and norfloxacin), macrolide antibiotics (e.g., erythromycin), fluvoxamine, and calcium channel blockers Concurrent nebulized or inhaled cromolyn, nedocromil, beta2-agonists, ipratropium, opioids, benzodiazepines, oxygen, and diuretics allowed if dose is stable for more than 1 week prior to study No concurrent paracentesis (i.e., thoracentesis) No concurrent blood transfusion
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2W-W1T8
Algoma District Medical Group
Sault Ste. Marie, Ontario, P6B 1Y5
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients
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.
Read the 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 (e.g., 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.
- Conditions
- Pulmonary Complications, Quality of Life, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- theophylline, quality-of-life assessment
- Keywords
- unspecified adult solid tumor, protocol specific, pulmonary complications, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theophyllineDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2004 (estimated)
- Study start24 Mar 1998
- Primary completion15 Dec 2008
- Study completion15 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Deborah J. Dudgeon, MD, RN, Study chair, Cancer Research Institute at Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003684
- Sponsor's protocol ID
- SC14
- Other IDs
- CAN-NCIC-SC14, CDR0000066786
- Status last verified
- Apr 2020
- First submitted
- 1 Nov 1999
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Double-Blind Study of Theophylline Versus Placebo for the Treatment of Dyspnea in Cancer Patients
- ClinicalTrials.gov ID
- NCT00003684
- Acronym / sponsor ID
- SC14
- Conditions
- Pulmonary Complications, Quality of Life, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- unspecified adult solid tumor, protocol specific, pulmonary complications, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 24 Mar 1998 (actual)
- Primary completion
- 15 Dec 2008 (actual)
- Study completion
- 15 Dec 2008 (actual)
- First posted
- 17 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (e.g., 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 16 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| theophylline | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah J. Dudgeon, MD, RN study chair
Cancer Research Institute at Queen's University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing theophylline and quality-of-life assessment in people with Pulmonary Complications and Quality of Life, run by NCIC Clinical Trials Group at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.