High Flow Oxygen and Bilevel Airway Pressure for Persistent Dyspnea in Patients With Advanced Cancer

NCT00934128 | Completed Phase 2 Results DMC

• 1 other identifier: 2009-0164
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if specialized breathing devices reduce the sensation of shortness of breath in patients with advanced cancer who are experiencing shortness of breath. Researchers want to learn if these devices can help to control shortness of breath. The 2 devices being tested and compared are called BiPAP (bilevel positive airway pressure) and Vapotherm.

Conditions

Advanced Cancers

Keywords

Advanced Cancer; Persistent Dyspnea; Shortness of breath; Specialized breathing devices; Bilevel positive airway pressure device; BIPAP; High flow oxygen delivery device; VapoTherm; Edmonton Symptom Assessment Scale; ESAS

Outcome Measures

Primary Outcomes (2)

• Number of Participants Completing Study Intervention

  Retention rate defined as the percentage of subjects able to complete the first phase (washout) of study. A variable washout/follow-up period after the first intervention was used to determine the optimal duration required for participants to return to baseline dyspnea level. After participants completed the first intervention by one hour, they were able to proceed to the second intervention if (1) their dyspnea level was \>/= baseline dyspnea level-1, or (2) their dyspnea level was \>/= 3/10 after one hour.

  Minimally 1 hour, up to 5 hours

• Effects of BIPAP and VapoTherm Device on Severity of Dyspnea as Measured by the Numeric Rating Scale

  Dyspnea, a subjective sensation experienced by participants, was assessed with the numeric rating scale (NRS) before and after each 2 hour intervention. The NRS is a validated 11-point scale ranging from 0 (no dyspnea) to 10 (worst dyspnea). Participants received either (1) 2 hours of HFO followed by a variable washout period and then 2 hours of BiPAP or (2) 2 hours of BiPAP followed by a variable wash-out period and then 2 hours of HFO.

  Up to 5 hours, baseline/enrollment to 5 hours (2 hours for each treatment with variable wash-out period)

Study Arms (2)

Group 1: BiPAP then Vapotherm

EXPERIMENTAL

Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.

Device: Vapotherm; Device: BIPAP

Group 2: Vapotherm then BiPAP

EXPERIMENTAL

Vapotherm air delivery then BiPAP.

Device: Vapotherm; Device: BIPAP

Interventions

Vapotherm DEVICE

Deliver air in and out of the lungs, warmed, filtered for bacteria, and then delivered through the nose using a tube under the nostrils.

Also known as: High flow oxygen delivery system

Group 1: BiPAP then Vapotherm; Group 2: Vapotherm then BiPAP

BIPAP DEVICE

Air given through a mask, and amount can be set to different levels allowing more air in and out of lungs without using as much effort as regular breathing.

Also known as: Bilevel positive airway pressure device

Group 1: BiPAP then Vapotherm; Group 2: Vapotherm then BiPAP

Eligibility Criteria

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

You may qualify if:

• History of advanced cancer, defined as locally advanced, recurrent or metastatic disease
• Patients with persistent dyspnea, defined in this study as dyspnea at rest with an average intensity level \>/=3 out of a Numeric Rating Scale from 0 to 10 for at least 2 week and just prior to study initiation, despite supplemental oxygen of up to 21 L/min to keep oxygen saturation \>/=90%
• Dyspnea is judged clinical to be predominantly due to underlying malignancy, with or without obstructive lung disease
• Inpatient at MD Anderson Cancer Center
• Patients with cancer treatment related dyspnea are eligible for this study if they meet the eligibility criteria above.
• Able to communicate in English
• Expected life expectancy \>1 week
• Patients with a diagnosis of pneumonia are also eligible for this study if they meet the eligibility criteria above, with dyspnea \>=2 weeks prior to the diagnosis of pneumonia.
• Age 18 or greater

You may not qualify if:

• Hemodynamic instability (Heart Rate (HR) \>140, systolic blood pressure (SBP) \<80) within 24 hours of study initiation (as per Clinic Station)
• Acute respiratory distress requiring intubation
• Delirium as indicated by a Memorial Delirium Assessment Scale (MDAS) of 13 or higher
• Glasglow coma scale \<8
• Excessive airway secretions interfering with BIPAP administration
• History of facial trauma within 1 month of enrollment
• Upper GI bleed within 2 weeks of enrollment or esophageal rupture
• Partial or complete small bowel obstruction or severe nausea/vomiting (ESAS nausea \>7/10) within 48 hours of enrollment
• Hemoglobin \<8 g/dL at the time of enrollment (blood draw within last 2 weeks)
• Acute exacerbation of COPD or CHF within 2 weeks of enrollment by history or physical
• Unwilling to provide informed consent
• Diagnosis of non-cancer related dyspnea (e.g. Chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF) or any chronic respiratory disease) requiring supplemental home oxygen prior to hospitalization.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Hui, MD, MSc, FRCPC
• Organization: The University of Texas (UT) MD Anderson Cancer Center

HMoreno@mdanderson.org

Study Officials

• David Hui, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 2, 2016
• Results First Posted: March 2, 2016

Record last verified: 2016-02

Locations

US (1)