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Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

NCT04188418 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-19

No results posted yet for this study

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

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Interventions

DRUG

Fentanyl Citrate Buccal Tablet

Given transmucosally

DRUG

Morphine

Given PO

OTHER

Physical Performance Testing

Complete shuttle walk test

OTHER

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David Hui · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-23
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188418 on ClinicalTrials.gov