Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-23

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVE:

I. 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).

SECONDARY OBJECTIVES:

I. 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.

II. 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.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP 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.

GROUP 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.

GROUP 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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I (shuttle walk test, FBT)

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

Group Type EXPERIMENTAL

Fentanyl Citrate Buccal Tablet

Intervention Type DRUG

Given transmucosally

Physical Performance Testing

Intervention Type OTHER

Complete shuttle walk test

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (shuttle walk test, morphine)

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

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

Given PO

Physical Performance Testing

Intervention Type OTHER

Complete shuttle walk test

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group III (shuttle walk test, placebo)

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.

Group Type ACTIVE_COMPARATOR

Physical Performance Testing

Intervention Type OTHER

Complete shuttle walk test

Placebo Administration

Intervention Type OTHER

Given PO

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Fentanyl Citrate Buccal Tablet

Given transmucosally

Intervention Type DRUG

Morphine

Given PO

Intervention Type DRUG

Physical Performance Testing

Complete shuttle walk test

Intervention Type OTHER

Placebo Administration

Given PO

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Fentora Physical Fitness Testing Physical Function Testing Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of cancer with evidence of active disease
2. Dyspnea on exertion with an average intensity level ≥4/10 on a modified Borg scale
3. Outpatient at participating centers
4. Ambulatory and able to walk, with or without walking aid
5. 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
6. Karnofsky performance status ≥40%
7. Age ≥18 yrs
8. Able to complete study assessments
9. Able to speak English or Spanish
10. Reside within 65 miles of participating centers or expected to visit MD Anderson in person at least once a month

Exclusion Criteria

1. Dyspnea at rest ≥7/10 on modified Borg scale at enrollment
2. Supplemental oxygen requirement \>6 L/min
3. Delirium (i.e. Memorial Delirium Assessment Scale ≥13)
4. History of unstable angina or myocardial infarction 1 mo prior to enrollment
5. Hemodynamic instability requiring hospitalization
6. 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
7. History of or known allergy to fentanyl or morphine sulfate
8. Using scheduled benzodiazepines at the time of enrollment and cannot stop during the study
9. Severe anemia (Hb \<7 g/L) if documented in the last month and not corrected prior to study enrollment\*
10. Bilirubin ≥5x upper limit of normal if documented in the last month and not lowered to \<5x normal prior to enrollment\*
11. Diagnosis of acute pulmonary embolism within past 2 wks
12. Diagnosis of pulmonary hypertension
13. Diagnosis of malignant pleural effusion with therapeutic thoracentesis expected in the next 2 wks
14. Currently pregnant or breastfeeding
15. Unwilling to provide informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No