Theophylline in Treating Cancer Patients With Shortness of Breath

NCT00003684 | Completed Phase 3 DMC

• 3 other identifiers: SC14CAN-NCIC-SC14CDR0000066786
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 4

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.

Conditions

Pulmonary Complications; Quality of Life; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; pulmonary complications; quality of life

Interventions

theophylline DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 16 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (4)

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Kingston Regional Cancer Centre

Kingston, Ontario, K7L 5P9, Canada

Location

Algoma District Medical Group

Sault Ste. Marie, Ontario, P6B 1Y5, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2W-W1T8, Canada

Location

MeSH Terms

Interventions

Theophylline

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Deborah J. Dudgeon, MD, RN

  Cancer Research Institute at Queen's University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 17, 2004
• Study Start: March 24, 1998
• Primary Completion: December 15, 2008
• Study Completion: December 15, 2008
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)