CancerPhase 2NCT00351715
Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients
A Phase 2 study testing Sublingual Methadone in people with Cancer and Pain, run by AHS Cancer Control Alberta at 2 sites in Canada.
Trial summary
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Sublingual Methadone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2008to Sep 2008
- Phase
- Phase 2
- 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
Who may be able to join
- Pain due to cancer or its treatment; controlled baseline pain;
- episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
- ast 10 minutes or longer, and
- are responsive to short acting oral opioids such as morphine or hydromorphone;
- are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
- are able to fill out the study forms
Who cannot join
- Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
- prior sensitivity to methadone;
- currently are being administered methadone;
- have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
- new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
- are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Tom Baker Cancer Centre
Calgary, Alberta
About this study
Official title: Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.
- Being tested
- Sublingual Methadone
- Keywords
- Sublingual Methadone, Cancer related breakthrough pain, feasibility study, Phase II/open label, Outpatients, Safety/ efficacy, previously receiving opioids, speak English
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual MethadoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic | Experimental | One episode of breakthrough pain was to be evaluated per patient. Clinical status and bloodwork was evaluated prior to entering into this phase of the trial, and patients were eligible if bloodwork demonstrated a HgB of >90 g/L with no concurrent bleeding. A peripheral intravenous catheter was inserted and saline locked. When breakthrough pain was experienced, methadone was administered, and the patient completed a pain intensity numeric rating scale at time 0 and every 10 minutes for one hour. A 10 cc specimen of blood was collected prior to administration of methadone, and again every 10 minutes for one hour. Blood was collected without anticoagulant, allowed to clot, separated by centrifugation, and serum samples flash frozen. Serum methadone levels were quantified by LC/MS/MS with comparison to isotopically labeled internal standards Receives: Drug: Sublingual Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting
Measured: 12 months
Secondary outcomes (3)
to develop a model of PK/PD study of breakthrough pain
Measured: Baseline to 5 years
to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)
Measured: Baseline to 5 years
to demonstrate proof of concept
Measured: Baseline to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Study stopped due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Neil Hagen, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351715
- Sponsor's protocol ID
- 20144
- Other IDs
- 22206
- Status last verified
- Oct 2008
- First submitted
- 11 Jul 2006
- Last updated
- 21 Oct 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study
- ClinicalTrials.gov ID
- NCT00351715
- Acronym / sponsor ID
- 20144
- Keywords
- Sublingual Methadone, Cancer related breakthrough pain, feasibility study, Phase II/open label, Outpatients, Safety/ efficacy, previously receiving opioids, speak English
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Jul 2006 (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.
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic | Experimental | Drug: Sublingual MethadoneOne episode of breakthrough pain was to be evaluated per patient. Clinical status and bloodwork was evaluated prior to entering into this phase of the trial, and patients were eligible if bloodwork demonstrated a HgB of >90 g/L with no concurrent bleeding. A peripheral intravenous catheter was inserted and saline locked. When breakthrough pain was experienced, methadone was administered, and the patient completed a pain intensity numeric rating scale at time 0 and every 10 minutes for one hour. A 10 cc specimen of blood was collected prior to administration of methadone, and again every 10 minutes for one hour. Blood was collected without anticoagulant, allowed to clot, separated by centrifugation, and serum samples flash frozen. Serum methadone levels were quantified by LC/MS/MS with comparison to isotopically labeled internal standards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pain due to cancer or its treatment; controlled baseline pain;
- episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
- ast 10 minutes or longer, and
- are responsive to short acting oral opioids such as morphine or hydromorphone;
- are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
Key exclusion criteria (6 listed)
- Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
- prior sensitivity to methadone;
- currently are being administered methadone;
- have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
- new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
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 |
|---|---|---|
| Sublingual Methadone | Drug | Pharmacokinetic |
Primary outcome
to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting
Time frame: 12 months
3 secondary outcomes
to develop a model of PK/PD study of breakthrough pain
Time frame: Baseline to 5 years
to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)
Time frame: Baseline to 5 years
to demonstrate proof of concept
Time frame: Baseline to 5 years
Results and safety
The study was stopped early (reason given: Study stopped due to low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
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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.
Neil Hagen, MD principal investigator
AHS Cancer Control Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sublingual Methadone in people with Cancer and Pain, run by AHS Cancer Control Alberta at 2 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?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Study stopped due to low 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?
to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting (time frame: 12 months). 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 21 Oct 2019.