Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Dyspnea

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Anticoagulants

Other Dietary Supplements

Fentanyl

Morphine

Analgesics, Opioid

Citric Acid

Sodium Citrate

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Citrate

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

Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.

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.

Fentanyl Citrate Buccal Tablet

Physical Performance Testing

Placebo Administration

Quality-of-Life Assessment

Questionnaire Administration

David Hui

This phase II trial studies fentanyl buccal tablet 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 tablet 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.

PRIMARY OBJECTIVE:

I. To compare the effect of prophylactic fentanyl buccal tablet (FBT), 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 FBT, 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 \[ESAS\]), quality of life (EuroQol-5 Dimension-5 Level \[EQ-5D-5L\]), and dyspnea severity and functional impairment based on the Patient Reported Outcomes Measurement Information System (PROMIS) dyspnea instruments.

II. To explore the effects of prophylactic FBT, 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 FBT 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.

Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

Efficacy and Safety of Rapid-Onset Opioids for Exertional Dyspnea in Cancer Patients

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.

Will be analyzed using linear mixed effects models similar to the primary analysis.

Will be measured by the Edmonton Symptom Assessment System and analyzed using linear mixed effects models similar to the primary analysis.

Will be measured by the EuroQol-5 Dimension-5 Level Questionnaire and analyzed using linear mixed effects models similar to the primary analysis.

Will perform paired t-test or ANOVA if the data are normally distributed and the Wilcoxon rank-sum test or Kruskal-Wallis if the data are non-normal.

Will be measured by the Drug Effects Questionnaire. Will perform paired t-test or ANOVA if the data are normally distributed and the Wilcoxon rank-sum test or Kruskal-Wallis if the data are non-normal.

Will be measured by the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Will perform paired t-test or ANOVA if the data are normally distributed and the Wilcoxon rank-sum test or Kruskal-Wallis if the data are non-normal.

Will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) dyspnea instruments.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients	NCT04188418	Hematopoietic a... Malignant Solid...	Fentanyl Citrat... Morphine Physical Perfor... Placebo Adminis... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients	NCT04188418	Hematopoietic a... Malignant Solid...	Fentanyl Citrat... Morphine Physical Perfor... Placebo Adminis... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for fentanyl citrate buccal tablet