Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

NCT04188418 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 2019-0701NCI-2019-07529R01CA231471
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT)

  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.

  Days 5, 8, 12, 15, and 19

Secondary Outcomes (13)

• SWT distance

  Days 5, 8, 12, 15, and 19

• Dyspnea unpleasantness

  Days 5, 8, 12, 15, and 19

• Daily dyspnea intensity and unpleasantness

  Days 1-19

• Personalized daily activity

  Days 1-4, 6-7, 9-11, 13-14, and 16-18

• Oxygen cost diagram

  Days 1-19

Study Arms (3)

Group I (shuttle walk test, FBT)

EXPERIMENTAL

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

Drug: Fentanyl Citrate Buccal Tablet; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group II (shuttle walk test, morphine)

EXPERIMENTAL

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; Other: Physical Performance Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Group III (shuttle walk test, placebo)

ACTIVE COMPARATOR

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; Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Fentanyl Citrate Buccal Tablet DRUG

Given transmucosally

Also known as: Fentora

Group I (shuttle walk test, FBT)

Morphine DRUG

Given PO

Group II (shuttle walk test, morphine)

Physical Performance Testing OTHER

Complete shuttle walk test

Also known as: Physical Fitness Testing, Physical Function Testing

Group I (shuttle walk test, FBT); Group II (shuttle walk test, morphine); Group III (shuttle walk test, placebo)

Placebo Administration OTHER

Given PO

Group III (shuttle walk test, placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (shuttle walk test, FBT); Group II (shuttle walk test, morphine); Group III (shuttle walk test, placebo)

Questionnaire Administration OTHER

Ancillary studies

Group I (shuttle walk test, FBT); Group II (shuttle walk test, morphine); Group III (shuttle walk test, placebo)

Eligibility Criteria

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

You may qualify if:

• 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 60-400 mg for ≥1 wk (i.e. at least 4 out of 7 days), with stable (i.e. ±30%) regular dose over the last 3 d
• Karnofsky performance status ≥40%
• Age ≥18 yrs
• Able to complete study assessments
• Able to speak English or Spanish
• Reside within 65 miles of participating centers or expected to visit MD Anderson in person at least once a month

You may not qualify if:

• 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 mo prior to enrollment
• Hemodynamic instability requiring hospitalization
• 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
• Using scheduled benzodiazepines at the time of enrollment and cannot stop during the study
• Severe anemia (Hb \<7 g/L) if documented in the last month and not corrected prior to study enrollment\*
• Bilirubin ≥5x upper limit of normal if documented in the last month and not lowered to \<5x normal prior to enrollment\*
• Diagnosis of acute pulmonary embolism within past 2 wks
• Diagnosis of pulmonary hypertension
• Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 wks
• Currently pregnant or breastfeeding
• Unwilling to provide informed consent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hui D, Pacheco S, Nguyen L, Jennings K, de la Cruz V, Stanton P, Laureano R, Ontai A, Mahler D, Bruera E. Efficacy of fentanyl buccal tablet and morphine for exertional dyspnoea in patients with cancer: a double-blind, placebo-controlled, randomised clinical trial. Thorax. 2026 Mar 13;81(4):344-356. doi: 10.1136/thorax-2025-222970.

  PMID: 41115797 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Fentanyl; Morphine; Exercise Test

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• David Hui

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: December 5, 2019
• Study Start: October 23, 2020
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)