Trial Outcomes & Findings for Morphine Versus Methadone As First Line Strong Opioid for Cancer Pain (NCT NCT00634010)

Last Updated: 2016-05-09

Results Overview

Brief Pain Inventory (BPI): Pain severity measured with BPI, which asks participants to rate pain for last 24 hours on 0 to 10 scales at its "worst", "least", "average " and "now". The scales are presented on a 10 cm line, with each number equidistant from the next. Each scale is bounded by the words "no pain' at the 0 end and "pain as bad as you can imagine" at the other. BPI used to determine whether methadone used as first line strong opioid is superior to morphine as evidenced by reduced pain over a 4 week (+/- 3 days) treatment period in participants with advanced cancer.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

36 participants

Primary outcome timeframe

Comparing baseline and pain scores at 4 weeks (+/- 3 days)

Results posted on

2016-05-09

Participant Flow

Recruitment period: February 22, 2008 to September 14, 2010. All recruitment done within medical clinics at The University of Texas MD Anderson Cancer Center and Lyndon Baines Johnson Hospital.

Participant milestones

Participant milestones
Measure	Morphine Capsule Morphine 5 mg slow release morphine orally every 12 hours and 5 mg immediate-release morphine every 2 hours as needed for breakthrough pain.	Methadone Capsule Methadone 5 mg orally every 12 hours and 5 mg immediate-release (IR) Morphine every 2 hours as needed for rescue pain (for first week).
Overall Study STARTED	18	18
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	10	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Morphine Capsule Morphine 5 mg slow release morphine orally every 12 hours and 5 mg immediate-release morphine every 2 hours as needed for breakthrough pain.	Methadone Capsule Methadone 5 mg orally every 12 hours and 5 mg immediate-release (IR) Morphine every 2 hours as needed for rescue pain (for first week).
Overall Study Adverse Event	2	5
Overall Study Withdrawal by Subject	5	6
Overall Study Physician Decision	1	1
Overall Study Disease Progression	1	1
Overall Study Non-Compliant	1	1

Baseline Characteristics

Morphine Versus Methadone As First Line Strong Opioid for Cancer Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine Capsule n=18 Participants Morphine 15 mg slow release orally every 12 hours + additional doses as needed	Methadone Capsule n=18 Participants Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day	Total n=36 Participants Total of all reporting groups
Age, Continuous	56.00 years STANDARD_DEVIATION 8.677 • n=93 Participants	60.39 years STANDARD_DEVIATION 12.069 • n=4 Participants	57.4 years STANDARD_DEVIATION 10.430 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	11 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	7 Participants n=4 Participants	16 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	18 participants n=93 Participants	18 participants n=4 Participants	36 participants n=27 Participants

PRIMARY outcome

Timeframe: Comparing baseline and pain scores at 4 weeks (+/- 3 days)

Population: The study was terminated without completing any analysis because the sample size was too small to detect any differences between the groups. Participants eligible for the study often had significant symptom distress and could not continue in the four week study period needed for data collection contribution to mean calculation.

Outcome measures

Outcome data not reported

Adverse Events

Morphine Capsule

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Methadone Capsule

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Eduardo Bruera, MD, Chair, Palliative Care Medicine

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Morphine Capsule n=18 participants at risk Morphine 15 mg slow release orally every 12 hours + additional doses as needed	Methadone Capsule n=18 participants at risk Methadone 5 mg orally every 12 hours + additional as needed doses up to 40-50 mg/day
Gastrointestinal disorders Abdominal distension	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Psychiatric disorders Agitation	5.6% 1/18 • Number of events 10 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Investigations Alanine aminotransferase increased	5.6% 1/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 3 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Investigations Alkaline phosphatase increased	11.1% 2/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 3 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	11.1% 2/18 • Number of events 3 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Metabolism and nutrition disorders Anorexia	27.8% 5/18 • Number of events 5 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	22.2% 4/18 • Number of events 5 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Psychiatric disorders Anxiety	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	11.1% 2/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Gastrointestinal disorders Ascites	5.6% 1/18 • Number of events 4 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Skin and subcutaneous tissue disorders Atrophy skin	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	11.1% 2/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	16.7% 3/18 • Number of events 29 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Metabolism and nutrition disorders Bilirubin increased	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	11.1% 2/18 • Number of events 5 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Metabolism and nutrition disorders Blood glucose increased	22.2% 4/18 • Number of events 5 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	11.1% 2/18 • Number of events 3 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Metabolism and nutrition disorders Blood uric acid increased	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Reproductive system and breast disorders Breast pain	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 3 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Cardiac disorders Cardiac troponin T increased	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Psychiatric disorders Confusion	11.1% 2/18 • Number of events 10 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	27.8% 5/18 • Number of events 7 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Gastrointestinal disorders Constipation	61.1% 11/18 • Number of events 37 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	66.7% 12/18 • Number of events 30 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Investigations Creatinine increased	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Metabolism and nutrition disorders Dehydration	11.1% 2/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Nervous system disorders Depressed level of consciousness	27.8% 5/18 • Number of events 5 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	50.0% 9/18 • Number of events 20 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Psychiatric disorders Depression	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Gastrointestinal disorders Diarrhea	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Nervous system disorders Dizziness	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	33.3% 6/18 • Number of events 15 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Gastrointestinal disorders Dry mouth	16.7% 3/18 • Number of events 3 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	33.3% 6/18 • Number of events 21 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 2/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	22.2% 4/18 • Number of events 8 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
General disorders Edema limbs	22.2% 4/18 • Number of events 4 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	33.3% 6/18 • Number of events 10 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Gastrointestinal disorders Esophageal pain	5.6% 1/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Nervous system disorders Extrapyramidal disorder	5.6% 1/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	11.1% 2/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Eye disorders Eye pain	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 4 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
General disorders Fatigue	44.4% 8/18 • Number of events 8 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	61.1% 11/18 • Number of events 32 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
General disorders Fever	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Gastrointestinal disorders Flatulence	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Investigations Haptoglobin decreased	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Nervous system disorders Headache	5.6% 1/18 • Number of events 2 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Metabolism and nutrition disorders Hemoglobin decreased	22.2% 4/18 • Number of events 16 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	11.1% 2/18 • Number of events 4 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Respiratory, thoracic and mediastinal disorders Hiccough	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Vascular disorders Hypotension	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.	5.6% 1/18 • Number of events 1 • Adverse events collected from baseline to Day 85, anticipated study period 12 weeks.