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Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

StatusActive, Not Recruiting
PhasePhase 3
Started2020-10-23
View on ClinicalTrials.gov ↗

Amendment history

2026-08-07
2 amendments v10-v11
2 re-verifications since 2026-02-17, no change to tracked fields
2025-08-20
Study Status v9
Primary completion date2025-08-31→2027-08-31
Completion date2025-08-31→2027-08-31
2024-09-20
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2024-06-26
Study Status v7
Re-verified, no change to tracked fields
2023-12-11
Study Status, Eligibility v6
Eligibility criteria+49 characters
[...] disease Dyspnea on exertion with an average intensity level >= ≥4/10 on a modified Borg scale Outpatient at participating ce [...] ng opioids with morphine equivalent daily dose (MEDD) of 60-370400 mg for >= ≥1 weekwk (wki.e. at least 4 out of 7 days), with stable (i.e. +/- ±30%) regular dose over the last 3 days (d) Karnofsky performance status >= ≥40% Age >= ≥18 years (yrs) Able to complete study assessments Able to speak English or Spanish Reside within 5065 miles of participating centers or expected to visit MD Anderson in person at least once a month Exclusion Criteria: Dyspnea at rest >= ≥7/10 [...] [...]
Show 5 earlier versions
2023-06-21
2 amendments v4-v5
2 re-verifications since 2023-04-05, no change to tracked fields
2021-11-12
Study Status v3
Start date2020-10-08→2020-10-23
2021-10-20
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-04-30→confirmed 2020-10-08
Eligibility criteria+22 characters
[...] ver the last 3 days (d) Karnofsky performance status >= 40% Age >= 18 years (yrs) Able to complete study assessments Able to speak English or [...]
Secondary endpoints1 to 13 entries
SWT (shuttledistance Dyspnea walkunpleasantness Daily testdyspnea )intensity distanceand unpleasantness Personalized daily activity Oxygen cost diagram Symptom burden Questionnaires Quality of life Questionnaires Neurocognitive function Addictive potential Frequency, severity, and interference of adverse effects Total opioid dose Number of rescue doses per day Dyspnea severity and f [...]
Study sitesdetails revised at 1 of 1 site
Study title-54 characters
Fentanyl SublingualBuccal Tablet or Morphine for theExertional Control of Shortness of Breath During or After Physical ActivityDyspnea in Cancer Patients
2020-07-14
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v1
Start date2020-04-30→2021-04-30
InterventionsFentanyl Sublingual Spray (Drug), Morphine (Drug), Physical Performance Testing (Other), Placebo (Other), Quality-of-Life Assessment…→Fentanyl Citrate Buccal Tablet (Drug), Morphine (Drug), Physical Performance Testing (Other), Placebo Administration (Other)…
Eligibility criteria+9 characters
[...] trong opioids with morphine equivalent daily dose (MEDD) of 8060-300370 mg for >= 1 week (wk), with stable (i.e. +/- 30%) regular dose over the last 3 days (d) Karnofsky performance status >= 40% Able to complete study [...]
Study description+140 characters
PRIMARY OBJECTIVE: I. To compare the effect of prophylactic fentanyl sublingualbuccal spraytablet (FSSFBT), morphine sulfate, and placebo on the increase in the inte [...] NDARY OBJECTIVES: I. To compare the effects of prophylactic FSSFBT, morphine sulfate, and placebo on SWT distance and dyspnea [...] symptom burden (Edmonton Symptom Assessment System [ESAS]), and 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 prophylact [...] [...]
Study sitescontacts updated at 1 of 1 site
Study title+1 characters
Fentanyl Sublingual SprayTablet or Morphine for the Control of Shortness of Breath During or After Physical Activity in Cancer Patients
2019-12-03
Original filing
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.
Trial Details
NCT Number NCT04188418
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Enrollment 150 participants
Start Date 2020-10-23
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11