Nausea and VomitingPhase 1NCT00930332
Methadone Hydrochloride as First-Line Therapy in Treating Patients With Chronic Neuropathic Cancer Pain
A Phase 1 study testing methadone hydrochloride, questionnaire administration and management of therapy complications in people with Nausea and Vomiting and Pain, run by NCIC Clinical Trials Group at 7 sites in Canada.
Trial summary
RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with cancer. PURPOSE: This phase I trial is studying the side effects and best dose of methadone hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting, Pain, Sleep Disorders
- What is being tested?
- methadone hydrochloride, questionnaire administration and management of therapy complications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 7 sitesCanada
- Study dates
- 17 Jun 2010to 6 Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Patients diagnosed with cancer and experiencing chronic neuropathic pain syndrome
- Pain syndrome diagnosed by the investigator
- Pain syndrome related to the effects of cancer or its treatment (i.e., chemotherapy, radiotherapy, and surgery)
- Meets 1 of the following criteria:
- Need to be started on strong opioids
- Require an increase in opioid dose and are currently taking ≤ 75 mg of total daily dose of oral morphine equivalent
- Experiencing pain for ≥ 4 weeks with an average pain score of ≥ 4 or a worst pain score of ≥ 5 (using the 0-10 Brief Pain Inventory Scale) during the past 24 hours
- Requires strong opioids to control pain and is using an oral morphine-equivalent dose of 0-75 mg per day, on average, including breakthrough analgesia, within the past 3 full calendar days
- Mixed pain syndrome allowed provided the neuropathic component is the predominant pain
- Meets 1 of the following criteria:
- Receiving concurrent chemotherapy but the chronic neuropathic pain is not related to this treatment and is not expected to improve or worsen because of this therapy
- Received prior chemotherapy but discontinued treatment, has not received chemotherapy within the past 7 days, and no further chemotherapy is planned
- No prior chemotherapy
PATIENT CHARACTERISTICS:
- Karnofsky performance status 40-100%
- ALT and AST ≤ 3 times upper limit of normal (ULN)
- Creatinine ≤ 2 times ULN
- No other known laboratory abnormality that, in the investigator's opinion, would contraindicate study participation
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Mini-Mental State Examination score ≥ 25/30
- Able to speak, read, and write in either English or French
- Willing to complete study diary and questionnaires
- Available for study treatment and follow up (i.e., within reasonable geographical limits of the participating center)
- Able to swallow and tolerate oral medications
- Patients with prior exposure to methadone hydrochloride must be able to tolerate it
- No intractable nausea and vomiting
- No presence or history of unstable disease or condition that would, in the investigator's opinion, preclude patient participation in study treatment, such as:
- Head injury
- Increased intracranial pressure
- Uncontrolled seizures
- Uncontrolled asthma
- Decompensated chronic obstructive pulmonary disease
- Untreated prostate hypertrophy
- Acute abdominal conditions
- Untreated hyperthyroidism and Addison disease
- Increased cerebrospinal fluid pressure
- Urethral stricture
- Severe cardiac arrhythmias (especially prolonged QT interval)
- Symptomatic hypotension
- Toxic psychosis
- Cor pulmonale
- Sleep apnea
- Severe obesity
- Kyphoscoliosis
- Myxedema
- Central nervous system depression
- Coma
- No history of significant alcohol, analgesic, or narcotic substance abuse within the past 6 months
- Able physically and mentally to answer questions and comply with study treatment
- No patient who lives alone and cannot access at least 1 caregiver who can monitor on a daily basis at home
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior radiopharmaceutical treatment or radiotherapy
- Concurrent co-analgesics and medications that can affect methadone hydrochloride metabolism allowed provided patients have been on a stable dose for the past 3-5 days and ≥ 5 half lives have passed since any change in dose
- Not scheduled to start chemotherapy during the study treatment
- Not planning on starting or discontinuing medication associated with modified methadone hydrochloride clearance during study treatment
- No concurrent therapeutic procedure that is likely to influence pain intensity during the study period
- No concurrent other opioid medications
- No other concurrent methadone hydrochloride
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase I Study to Determine the Dose of Methadone as a First Line Agent in the Treatment of Chronic Neuropathic Cancer Pain
RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of methadone hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer pain.
Read the detailed description
OBJECTIVES:
Primary
- To determine the optimum starting dose (defined as the dose that does not require modification within the first 4 days of treatment for lack of efficacy or the occurrence of adverse events) of methadone hydrochloride as a first-line opioid treatment in patients with chronic neuropathic cancer pain.
Secondary
- To assess the number and timing of breakthrough analgesic usage.
- To assess the number of episodes of breakthrough pain.
- To assess the total daily dose of methadone hydrochloride.
- To assess the average pain score.
- To determine the safety and adverse event profile of methadone hydrochloride as a first-line opioid in the treatment of chronic neuropathic cancer pain.
- To assess the frequency and severity of sleep disturbance associated with the use of methadone hydrochloride.
- To determine the feasibility of recruiting patients with chronic neuropathic cancer pain in a reasonable time frame for a future phase III study of methadone hydrochloride vs morphine.
OUTLINE: This is a multicenter study. Patients are assigned to a group according to their average daily dosage of morphine-equivalent for the 3 full days prior to study entry (≤ 45 mg/day OR > 45 but ≤ 75 mg/day).
Patients receive oral methadone hydrochloride at various doses every 8 hours. Patients also may receive breakthrough oral methadone hydrochloride every 2 hours, as needed, for up to 6 breakthrough analgesics per day. Treatment continues for up to 35 days. Treatment stops if the patient has well-controlled pain or experiences intolerable side effects.
Patients complete the Short-Form McGill Pain Questionnaire at baseline. Patients rate their pain according to questions from the Brief Pain Inventory on a scale of 0 (no pain) to 10 (worst pain imaginable) to best describe pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on average, and pain right now; record the number and timing of breakthrough analgesic usage, the number of episodes of breakthrough pain, and the total daily dose of methadone hydrochloride; and complete nausea and sleep assessments once daily on days 1-14.
After completion of study treatment, patients are followed at 4, 6-7, and 28 days.
- Conditions
- Nausea and Vomiting, Pain, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- methadone hydrochloride, questionnaire administration, management of therapy complications
- Keywords
- sleep disorders, nausea and vomiting, unspecified adult solid tumor, protocol specific, pain
- Medical subject headings
- Nausea, Vomiting, Pain, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methadone hydrochlorideDrug
Level 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day)
Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 3mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
OR
Level 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
questionnaire administrationOther
within 48 hours of registration
management of therapy complicationsProcedure or surgery
if required
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Methadone | Active comparator | Level 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day)
Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Receives: Drug: methadone hydrochloride; Other: questionnaire administration; Procedure: management of therapy complications |
| Arm B: Methadone | Active comparator | Level 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day)
Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Receives: Drug: methadone hydrochloride; Other: questionnaire administration; Procedure: management of therapy complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimum starting dose
Measured: 28 days
Secondary outcomes (4)
Pain control as assessed by the number and timing of breakthrough analgesics, the number of episodes of breakthrough pain, the total daily dose of methadone, and the average pain scores
Measured: 28 days
Adverse events (including respiratory depression) according to NCI CTCAE v3.0 criteria
Measured: 28 days
Frequency and severity of sleep disturbance from pain
Measured: 28 days
Feasibility of recruiting patients
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study start17 Jun 2010
- Primary completion6 Jan 2012
- Study completion6 Jan 2012
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Bruno Gagnon, MD, MSC, Study chair, McGill Cancer Centre at McGill UniversityRay Viola, Study chair, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930332
- Sponsor's protocol ID
- SC22
- Other IDs
- CAN-NCIC-SC22, CDR0000641372
- Status last verified
- Apr 2020
- First submitted
- 27 Jun 2009
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Dose of Methadone as a First Line Agent in the Treatment of Chronic Neuropathic Cancer Pain
- ClinicalTrials.gov ID
- NCT00930332
- Acronym / sponsor ID
- SC22
- Conditions
- Nausea and Vomiting, Pain, Sleep Disorders, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- sleep disorders, nausea and vomiting, unspecified adult solid tumor, protocol specific, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 17 Jun 2010 (actual)
- Primary completion
- 6 Jan 2012 (actual)
- Study completion
- 6 Jan 2012 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Methadone hydrochloride may reduce chronic neuropathic pain in patients with cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of methadone hydrochloride as first-line therapy in treating patients with chronic neuropathic cancer pain.
Detailed description
OBJECTIVES:
Primary
- To determine the optimum starting dose (defined as the dose that does not require modification within the first 4 days of treatment for lack of efficacy or the occurrence of adverse events) of methadone hydrochloride as a first-line opioid treatment in patients with chronic neuropathic cancer pain.
Secondary
- To assess the number and timing of breakthrough analgesic usage.
- To assess the number of episodes of breakthrough pain.
- To assess the total daily dose of methadone hydrochloride.
- To assess the average pain score.
- To determine the safety and adverse event profile of methadone hydrochloride as a first-line opioid in the treatment of chronic neuropathic cancer pain.
- To assess the frequency and severity of sleep disturbance associated with the use of methadone hydrochloride.
- To determine the feasibility of recruiting patients with chronic neuropathic cancer pain in a reasonable time frame for a future phase III study of methadone hydrochloride vs morphine.
OUTLINE: This is a multicenter study. Patients are assigned to a group according to their average daily dosage of morphine-equivalent for the 3 full days prior to study entry (≤ 45 mg/day OR > 45 but ≤ 75 mg/day).
Patients receive oral methadone hydrochloride at various doses every 8 hours. Patients also may receive breakthrough oral methadone hydrochloride every 2 hours, as needed, for up to 6 breakthrough analgesics per day. Treatment continues for up to 35 days. Treatment stops if the patient has well-controlled pain or experiences intolerable side effects.
Patients complete the Short-Form McGill Pain Questionnaire at baseline. Patients rate their pain according to questions from the Brief Pain Inventory on a scale of 0 (no pain) to 10 (worst pain imaginable) to best describe pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on average, and pain right now; record the number and timing of breakthrough analgesic usage, the number of episodes of breakthrough pain, and the total daily dose of methadone hydrochloride; and complete nausea and sleep assessments once daily on days 1-14.
After completion of study treatment, patients are followed at 4, 6-7, and 28 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Methadone | Active comparator | Drug: methadone hydrochloride, Other: questionnaire administration, Procedure: management of therapy complicationsLevel 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day) Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Level 3: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) |
| Arm B: Methadone | Active comparator | Drug: methadone hydrochloride, Other: questionnaire administration, Procedure: management of therapy complicationsLevel 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methadone hydrochlorideLevel 1: 1 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA** per day) Level 2: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Level 3: 3mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) OR Level 1: 2 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Level 2: 3 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) Level 3: 4 mg q8h, breakthrough 1 mg q2h* (maximum 6 BTA per day) | Drug | Arm A: Methadone, Arm B: Methadone |
| questionnaire administrationwithin 48 hours of registration | Other | Arm A: Methadone, Arm B: Methadone |
| management of therapy complicationsif required | Procedure or surgery | Arm A: Methadone, Arm B: Methadone |
Primary outcome
Optimum starting dose
Time frame: 28 days
4 secondary outcomes
Pain control as assessed by the number and timing of breakthrough analgesics, the number of episodes of breakthrough pain, the total daily dose of methadone, and the average pain scores
Time frame: 28 days
Adverse events (including respiratory depression) according to NCI CTCAE v3.0 criteria
Time frame: 28 days
Frequency and severity of sleep disturbance from pain
Time frame: 28 days
Feasibility of recruiting patients
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Gagnon, MD, MSC study chair
McGill Cancer Centre at McGill University
Ray Viola study chair
Queen's University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing methadone hydrochloride, questionnaire administration and management of therapy complications in people with Nausea and Vomiting and Pain, run by NCIC Clinical Trials Group at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimum starting dose (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.