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NCT04188418 · ClinicalTrials.gov registry record · Phase 3
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients
A Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04188418: Active Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04188418 is a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 150 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04188418, a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Physical Performance Testing
- DRUG Morphine
- OTHER Placebo Administration
- DRUG Fentanyl Citrate Buccal Tablet
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-10-23 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 3 |
What the registry record for NCT04188418 still lists
NCT04188418 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04188418 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04188418 about?
NCT04188418 is a clinical study titled "Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients". 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 ...
What is the current status of trial NCT04188418?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2020-10-23. Estimated completion is 2027-08-31.
What conditions does trial NCT04188418 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm.
What interventions are being tested in trial NCT04188418?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Physical Performance Testing (OTHER), Morphine (DRUG), Placebo Administration (OTHER), Fentanyl Citrate Buccal Tablet (DRUG).
Who is sponsoring clinical trial NCT04188418?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04188418 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04188418's enrollment target sits among peer trials
150 76th of 176 higher than 100 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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