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Fentanyl Sublingual Spray or Morphine for the Control of Shortness of Breath During or After Physical Activity in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188418
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase III trial studies fentanyl sublingual (under the tongue) spray or morphine to see how well it works compared to a placebo in controlling shortness of breath during or after physical activity in cancer patients. Fentanyl sublingual spray and morphine are opioids normally used to control pain that may also help to prevent or control shortness of breath during or after physical activity in cancer patients.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Drug: Fentanyl Sublingual Spray Drug: Morphine Other: Physical Performance Testing Other: Placebo Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare the effect of prophylactic fentanyl sublingual spray (FSS), morphine sulfate, and placebo on the increase in the intensity of exertional dyspnea (0-10 point modified Borg scale) measured before versus at the end of a shuttle walk test (SWT).

SECONDARY OBJECTIVES:

I. To compare the effects of prophylactic FSS, morphine sulfate, and placebo on SWT distance and dyspnea unpleasantness, average daily dyspnea (intensity and unpleasantness, oxygen cost diagram), personalized daily activity (ability to complete activity), personalized dyspnea response, symptom burden (Edmonton Symptom Assessment System [ESAS]), and quality of life (EuroQol-5 Dimension-5 Level [EQ-5D-5L]).

II. To explore the effects of prophylactic FSS, morphine sulfate, and placebo on neurocognitive function, addictive potential (Drug Effects Questionnaire), adverse effects (Common Terminology Criteria for Adverse Events [CTCAE], Patient-Reported Outcomes version of CTCAE [PRO-CTCAE]), and pattern of opioid use.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FSS sublingually daily on days 6-19.

GROUP II: Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine orally (PO) daily on days 6-19.

GROUP III: Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive placebo (sublingually or PO) daily on days 6-19.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rapid-Onset Opioids for Exertional Dyspnea in Cancer Patients
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (shuttle walk test, FSS)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FSS sublingually daily on days 6-19.
Drug: Fentanyl Sublingual Spray
Given sublingually
Other Name: FSS

Other: Physical Performance Testing
Complete shuttle walk test
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Group II (shuttle walk test, morphine)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.
Drug: Morphine
Given PO

Other: Physical Performance Testing
Complete shuttle walk test
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Group III (shuttle walk test, placebo)
Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive placebo (sublingually or PO) daily on days 6-19.
Other: Physical Performance Testing
Complete shuttle walk test
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing

Other: Placebo
Given sublingually or PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT) [ Time Frame: Days 5, 8, 12, 15, and 19 ]
    Will first determine whether the three treatment groups are different; if so, will test the three pairwise comparisons with intention-to-treat analyses. Repeated-measures analysis of variance (ANOVA) will be implemented using linear mixed effects models with the difference in intervention period SWT modified Borg scale dyspnea intensity before and after SWT as the response variable and the treatment group and observation period SWT measures as predictor variables.


Secondary Outcome Measures :
  1. SWT (shuttle walk test ) distance [ Time Frame: Days 5, 8, 12, 15, and 19 ]
    Will be analyzed using linear mixed effects models similar to the primary analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Diagnosis of cancer with evidence of active disease
  • Dyspnea on exertion with an average intensity level >= 4/10 on a modified Borg scale
  • Outpatient at participating centers
  • Ambulatory and able to walk, with or without walking aid
  • On strong opioids with morphine equivalent daily dose (MEDD) of 80-300 mg for >= 1 week, with stable (i.e. +/- 30%) regular dose over the last 3 days
  • Karnofsky performance status >= 40%
  • Able to complete study assessments
  • Able to speak English or Spanish
  • Reside within 50 miles of participating centers

Exclusion Criteria:

  • Dyspnea at rest >= 7/10 on modified Borg scale at enrollment
  • Supplemental oxygen requirement > 6 L/min
  • Delirium (i.e. Memorial Delirium Assessment Scale >= 13)
  • History of unstable angina or myocardial infarction 1 month prior to enrollment
  • Resting heart rate > 120 beats/min at enrollment
  • Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg at enrollment
  • History of substance use disorder or abnormal urinary drug screen within the past year, or at risk of opioid abuse as determined by Screener and Opioid Assessment for Patients with Pain (SOAPP14) >= 7
  • History of or known allergy to fentanyl or morphine sulfate
  • Currently prescribed benzodiazepines
  • Severe anemia (Hemoglobin [Hb] < 7 g/L) if documented in the last month and not corrected prior to study enrollment
  • Bilirubin >=5 x upper limit of normal if documented in the last month and not lowered to < 5 x normal prior to enrollment
  • Diagnosis of acute pulmonary embolism within past 2 weeks
  • Diagnosis of pulmonary hypertension
  • Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 weeks
  • Unwilling to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188418


Contacts
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Contact: David Hui 713-792-6085 dhui@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Contact: David Hui    713-792-6085      
Principal Investigator: David Hui         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David Hui M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04188418    
Other Study ID Numbers: 2019-0701
NCI-2019-07529 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0701 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics