Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-04 @ 10:18 PM
Study NCT ID:
NCT04188418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-12-03', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in modified Borg scale dyspnea intensity before and after the Shuttle Walk Test (SWT)', 'timeFrame': 'Days 5, 8, 12, 15, and 19', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'SWT distance', 'timeFrame': 'Days 5, 8, 12, 15, and 19', 'description': 'Will be analyzed using linear mixed effects models similar to the primary analysis.'}, {'measure': 'Dyspnea unpleasantness', 'timeFrame': 'Days 5, 8, 12, 15, and 19', 'description': 'Will be analyzed using linear mixed effects models similar to the primary analysis.'}, {'measure': 'Daily dyspnea intensity and unpleasantness', 'timeFrame': 'Days 1-19', 'description': 'Will be analyzed using linear mixed effects models similar to the primary analysis.'}, {'measure': 'Personalized daily activity', 'timeFrame': 'Days 1-4, 6-7, 9-11, 13-14, and 16-18', 'description': 'Will be analyzed using linear mixed effects models similar to the primary analysis.'}, {'measure': 'Oxygen cost diagram', 'timeFrame': 'Days 1-19', 'description': 'Will be analyzed using linear mixed effects models similar to the primary analysis.'}, {'measure': 'Symptom burden Questionnaires', 'timeFrame': 'Days 1-19', 'description': 'Will be measured by the Edmonton Symptom Assessment System and analyzed using linear mixed effects models similar to the primary analysis.'}, {'measure': 'Quality of life Questionnaires', 'timeFrame': 'Days 1-19', 'description': 'Will be measured by the EuroQol-5 Dimension-5 Level Questionnaire and analyzed using linear mixed effects models similar to the primary analysis.'}, {'measure': 'Neurocognitive function', 'timeFrame': 'Up to day 19', 'description': '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.'}, {'measure': 'Addictive potential', 'timeFrame': 'Up to day 19', 'description': '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.'}, {'measure': 'Frequency, severity, and interference of adverse effects', 'timeFrame': 'Up to day 19', 'description': '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.'}, {'measure': 'Total opioid dose', 'timeFrame': 'Up to day 19', 'description': '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.'}, {'measure': 'Number of rescue doses per day', 'timeFrame': 'Up to day 19', 'description': '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.'}, {'measure': 'Dyspnea severity and functional impairment', 'timeFrame': 'Day 1, 5, 12, 19', 'description': 'Will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) dyspnea instruments.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'referencesModule': {'references': [{'pmid': '41115797', 'type': 'DERIVED', 'citation': '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. 2025 Oct 20:thorax-2025-222970. doi: 10.1136/thorax-2025-222970. Online ahead of print.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. 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).\n\nSECONDARY OBJECTIVES:\n\nI. 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.\n\nII. 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.\n\nOUTLINE: Patients are randomized to 1 of 3 groups.\n\nGROUP 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.\n\nGROUP 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.\n\nGROUP 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of cancer with evidence of active disease\n2. Dyspnea on exertion with an average intensity level ≥4/10 on a modified Borg scale\n3. Outpatient at participating centers\n4. Ambulatory and able to walk, with or without walking aid\n5. 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\n6. Karnofsky performance status ≥40%\n7. Age ≥18 yrs\n8. Able to complete study assessments\n9. Able to speak English or Spanish\n10. Reside within 65 miles of participating centers or expected to visit MD Anderson in person at least once a month\n\nExclusion Criteria:\n\n1. Dyspnea at rest ≥7/10 on modified Borg scale at enrollment\n2. Supplemental oxygen requirement \\>6 L/min\n3. Delirium (i.e. Memorial Delirium Assessment Scale ≥13)\n4. History of unstable angina or myocardial infarction 1 mo prior to enrollment\n5. Hemodynamic instability requiring hospitalization\n6. 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\n7. History of or known allergy to fentanyl or morphine sulfate\n8. Using scheduled benzodiazepines at the time of enrollment and cannot stop during the study\n9. Severe anemia (Hb \\<7 g/L) if documented in the last month and not corrected prior to study enrollment\\*\n10. Bilirubin ≥5x upper limit of normal if documented in the last month and not lowered to \\<5x normal prior to enrollment\\*\n11. Diagnosis of acute pulmonary embolism within past 2 wks\n12. Diagnosis of pulmonary hypertension\n13. Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 wks\n14. Currently pregnant or breastfeeding\n15. Unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04188418', 'briefTitle': 'Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Efficacy and Safety of Rapid-Onset Opioids for Exertional Dyspnea in Cancer Patients', 'orgStudyIdInfo': {'id': '2019-0701'}, 'secondaryIdInfos': [{'id': 'NCI-2019-07529', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2019-0701', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}, {'id': 'R01CA231471', 'link': 'https://reporter.nih.gov/quickSearch/R01CA231471', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I (shuttle walk test, FBT)', 'description': 'Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive FBT sublingually daily on days 6-19.', 'interventionNames': ['Drug: Fentanyl Citrate Buccal Tablet', 'Other: Physical Performance Testing', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group II (shuttle walk test, morphine)', 'description': 'Patients complete shuttle walk test on days 1, 5, 8, 12, 15, and 19. Patients also receive morphine PO daily on days 6-19.', 'interventionNames': ['Drug: Morphine', 'Other: Physical Performance Testing', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III (shuttle walk test, placebo)', 'description': '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.', 'interventionNames': ['Other: Physical Performance Testing', 'Other: Placebo Administration', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Fentanyl Citrate Buccal Tablet', 'type': 'DRUG', 'otherNames': ['Fentora'], 'description': 'Given transmucosally', 'armGroupLabels': ['Group I (shuttle walk test, FBT)']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'Given PO', 'armGroupLabels': ['Group II (shuttle walk test, morphine)']}, {'name': 'Physical Performance Testing', 'type': 'OTHER', 'otherNames': ['Physical Fitness Testing', 'Physical Function Testing'], 'description': 'Complete shuttle walk test', 'armGroupLabels': ['Group I (shuttle walk test, FBT)', 'Group II (shuttle walk test, morphine)', 'Group III (shuttle walk test, placebo)']}, {'name': 'Placebo Administration', 'type': 'OTHER', 'description': 'Given PO', 'armGroupLabels': ['Group III (shuttle walk test, placebo)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (shuttle walk test, FBT)', 'Group II (shuttle walk test, morphine)', 'Group III (shuttle walk test, placebo)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Group I (shuttle walk test, FBT)', 'Group II (shuttle walk test, morphine)', 'Group III (shuttle walk test, placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Hui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}