Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer (TIDAL)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for patients and upsetting for their family. Although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. More relief is needed for these patients. The investigators are studying a drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways to allow easier breathing. Every patient will get the drug but also a placebo, in a random (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they feel better with the drug.

Condition or disease	Intervention/treatment	Phase
NSCLC; Dyspnea	Drug: Tiotropium; Drug: Placebo	Phase 2

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer
Study Start Date :	November 2010
Estimated Primary Completion Date :	June 2016
Estimated Study Completion Date :	August 2016

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Tiotropium; Inhaler	Drug: Tiotropium; Inhaler
Placebo Comparator: Placebo; Inhaler	Drug: Placebo; Inhaler

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 12 question Cancer Dyspnea Scale [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. 10 point Dyspnea numeric scale [ Time Frame: 6 weeks ]
2. 10 point Cough scale [ Time Frame: 6 weeks ]
3. Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L) [ Time Frame: 6 weeks ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer.
2. Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2).
3. New dyspnea or worsening dyspnea within the last 6 months per patient reporting.

Exclusion Criteria:

1. Age < 18.
2. An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator.
3. Life expectancy < 3 months.
4. Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure).
5. Myocardial infarction within the previous month.
6. Heart rate ≥ 120.
7. Active tuberculosis or tuberculosis receiving antibiotic therapy.
8. Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6).
9. Sensitivity to atropine.
10. Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease
11. Use of beta-adrenergic bronchodilators more than once per week.
12. Use of experimental therapy with known cholinergic or adrenergic effects.
13. Uncontrolled glaucoma.
14. Urinary retention.
15. An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks.
16. Symptomatic pleural or pericardial effusion.
17. Evidence of reversible proximal endobronchial obstruction.
18. Oxygen saturation < 90%.
19. A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization.
20. Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization.
21. Weight loss > 10% of usual body weight within 6 months.
22. Known pregnancy or lactating.

23. Unable to independently fill out quality of life forms or give informed consent.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: John Goffin, MD	905-387-9495 ext 64603	goffinj@hhsc.ca
Contact: Sherry McFarlan, RN	905-387-9495 ext 64407	smcfarla@hhsc.ca

Locations

Canada, Ontario
Juravinski Cancer Centre	Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sherry McFarlan, RN 905-387-9495 ext 64407 smcfarla@hhsc.ca
Principal Investigator: John Goffin, MD

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Investigators

Principal Investigator:	John Goffin, MD	Juravinski Cancer Centre and McMaster University

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Juravinski Cancer Centre, Actively Accruing Clinical Trials 

Responsible Party:	John Goffin, Associate Prof, McMaster University
ClinicalTrials.gov Identifier:	NCT01172925 History of Changes
Other Study ID Numbers:	2009-TIDAL
First Posted:	July 30, 2010
Last Update Posted:	May 27, 2015
Last Verified:	May 2015

Keywords provided by John Goffin, McMaster University:

NSCLC; dyspnea; phase II; crossover; tiotropium

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Dyspnea; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory	Signs and Symptoms; Tiotropium Bromide; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Parasympatholytics; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action