CancerPhase 3NCT01316744
Ketamine Hydrochloride and Best Pain Management in Treating Cancer Patients With Neuropathic Pain
A Phase 3 study testing ketamine hydrochloride, pharmacogenomic studies and questionnaire administration in people with Cancer, run by University of Glasgow at 3 sites in United Kingdom.
Trial summary
RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is not yet known whether ketamine hydrochloride given together with the best pain management is more effective than a placebo given together with the best pain management in treating neuropathic pain in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ketamine hydrochloride, pharmacogenomic studies and questionnaire administration
- Type of treatment
- Surgery or procedure
- How many people
- 214 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2009to Oct 2011
- Phase
- Phase 3
- 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:
- Histologically confirmed cancer
- Index neuropathic pain ≥ 4 on 0-10 (as defined by Leeds Assessment of Neuropathic Symptoms and Signs) that is related to underlying malignancy or resulting from treatment received for this malignancy
- McGill Sensory Scale Score > 5
- Received a trial of an adjuvant analgesic (gabapentin or amitriptyline or both)
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 2 months
- Fertile patients must use effective contraception
- Able to comply with study procedures
- Diastolic blood pressure ≤ 100 mm Hg at screening
- No seizures in past 2 years
- Not actively hallucinating
- No cerebrovascular disease (strokes)
- No psychotic disorders or cognitive impairment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior and no concurrent chemotherapy or radiotherapy that is likely to affect neuropathic pain
- No change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study
- No concurrent class I antiarrhythmic drugs
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XR
Contact Person, 44-131-777-3520, marie.fallon@ed.ac.uk
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Contact Person, 44-141-301-7033, john.welsh@ggc.scot.nhs.uk
- Recruiting
Royal Brompton Hospital
London, England, SW3 6NP
Contact Person, 44-207-886-6011, c.urch@ucl.ac.uk
About this study
Official title: A Randomized Double-Blind Controlled Trial of Ketamine Versus Placebo in Conjunction With Best Pain Management in Neuropathic Pain in Cancer Patients
RATIONALE: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is not yet known whether ketamine hydrochloride given together with the best pain management is more effective than a placebo given together with the best pain management in treating neuropathic pain in patients with cancer.
PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together with the best pain management to see how well it works compared with giving a placebo together with the best pain management in treating cancer patients with neuropathic pain.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether ketamine hydrochloride given in addition to best standard pain management improves malignant neuropathic pain compared to best standard pain management alone in patients with cancer.
Secondary
- To compare initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire.
- To compare difference in overall pain between the study arms based on the pain-intensity visual-analogue score (VAS).
- To compare difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale.
- To assess worst pain score (index neuropathic site) between the two arms.
- To compare patient distress between the two arms based on NCCN Distress Thermometer.
- To assess the side effects and tolerability of trial drug.
- To assess the effect of intervention on quality of life scores (based on Euroqol thermometer), anxiety and depression (based on HADS), and opioid requirements.
OUTLINE: This is a multicenter study.
- Stage 1 (Run-in Period): Opioid doses are optimized, under a defined schedule, for up to a maximum of 10 days to ensure that all patients are on an optimized and stable regimen* prior to randomization. Following the run-in-period, patients undergo reassessment. Patients who have improved pain scores (i.e., < 4/10 on the visual-analogue score in the past 24 hours or < 5 McGill Sensory Scale Score) are taken off the study. Patients whose scores have not improved continue on to Stage 2 of the study.
NOTE: *Stable regimen is defined as the same dose of controlled release and no more variation than 2 breakthrough opioid doses over the normal for that patient for a period of 48 hours.
- Stage 2 (Titration Period): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ketamine hydrochloride 4 times a day. Doses are titrated until when analgesia is achieved or individual side effects appear, for up to 14 days.
- Arm II: Patients receive an oral placebo 4 times a day. Doses are titrated until when analgesia is achieved or individual side effects appear, for up to 14 days.
- Stage 3 (Assessment Period): Patients receive the trial medication (i.e., ketamine hydrochloride or placebo) at the fixed optimum dose (reached during the titration period) for 16 days.
Patients are allowed to receive breakthrough opioids at any time during the study.
Patients complete quality-of-life and pain-assessment questionnaires periodically. Some patients may undergo blood sample collection periodically for pharmacogenomics studies at a later date.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
- Conditions
- Cancer
- Being tested
- ketamine hydrochloride, pharmacogenomic studies, questionnaire administration, assessment of therapy complications, quality-of-life assessment
- Keywords
- long-term effects secondary to cancer therapy in adults, anxiety disorder, depression, pain, unspecified adult solid tumor, protocol specific, neuropathy, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, BCR-ABL1 negative, blastic phase chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, mast cell leukemia
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression, Pain, Leukemia, Myeloid, Accelerated Phase, Leukemia, Biphenotypic, Acute, Congenital Abnormalities, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamine hydrochlorideDrug
pharmacogenomic studiesOther
questionnaire administrationOther
assessment of therapy complicationsProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
Secondary outcomes (7)
Initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire
Difference in overall pain between the study arms based on the visual-analogue score
Difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Worst pain score (index neuropathic site) in the previous 24 hours (between the two arms) at study baseline and then during study assessment period
Patient distress between the two arms based on NCCN Distress Thermometer
Side effects and tolerability of trial drug
Effect of the intervention on quality-of-life scores (based on Euroqol thermometer), anxiety and depression (based on HAD scale), and opioid requirements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startApr 2009
- Primary completionOct 2011 (estimated)
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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Investigators
- Marie T. Fallon, Principal investigator, Edinburgh Cancer Centre at Western General HospitalBarry J.A. Laird, MD, Principal investigator, Edinburgh Cancer Centre at Western General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316744
- Sponsor's protocol ID
- CDR0000696704
- Other IDs
- CRUK-KPS-2008-01, EU-21012, EUDRACT-2007-002080-27, ISRCTN-49116945
- Status last verified
- Mar 2011
- First submitted
- 15 Mar 2011
- Last updated
- 13 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Controlled Trial of Ketamine Versus Placebo in Conjunction With Best Pain Management in Neuropathic Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT01316744
- Acronym / sponsor ID
- CDR0000696704
- Conditions
- Cancer
- Keywords
- long-term effects secondary to cancer therapy in adults, anxiety disorder, depression, pain, unspecified adult solid tumor, protocol specific, neuropathy, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (estimated)
- First posted
- 16 Mar 2011 (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: Ketamine hydrochloride may lessen neuropathic pain in patients with cancer. It is not yet known whether ketamine hydrochloride given together with the best pain management is more effective than a placebo given together with the best pain management in treating neuropathic pain in patients with cancer.
PURPOSE: This randomized phase III trial is studying ketamine hydrochloride given together with the best pain management to see how well it works compared with giving a placebo together with the best pain management in treating cancer patients with neuropathic pain.
Detailed description
OBJECTIVES:
Primary
- To determine whether ketamine hydrochloride given in addition to best standard pain management improves malignant neuropathic pain compared to best standard pain management alone in patients with cancer.
Secondary
- To compare initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire.
- To compare difference in overall pain between the study arms based on the pain-intensity visual-analogue score (VAS).
- To compare difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale.
- To assess worst pain score (index neuropathic site) between the two arms.
- To compare patient distress between the two arms based on NCCN Distress Thermometer.
- To assess the side effects and tolerability of trial drug.
- To assess the effect of intervention on quality of life scores (based on Euroqol thermometer), anxiety and depression (based on HADS), and opioid requirements.
OUTLINE: This is a multicenter study.
- Stage 1 (Run-in Period): Opioid doses are optimized, under a defined schedule, for up to a maximum of 10 days to ensure that all patients are on an optimized and stable regimen* prior to randomization. Following the run-in-period, patients undergo reassessment. Patients who have improved pain scores (i.e., < 4/10 on the visual-analogue score in the past 24 hours or < 5 McGill Sensory Scale Score) are taken off the study. Patients whose scores have not improved continue on to Stage 2 of the study.
NOTE: *Stable regimen is defined as the same dose of controlled release and no more variation than 2 breakthrough opioid doses over the normal for that patient for a period of 48 hours.
- Stage 2 (Titration Period): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral ketamine hydrochloride 4 times a day. Doses are titrated until when analgesia is achieved or individual side effects appear, for up to 14 days.
- Arm II: Patients receive an oral placebo 4 times a day. Doses are titrated until when analgesia is achieved or individual side effects appear, for up to 14 days.
- Stage 3 (Assessment Period): Patients receive the trial medication (i.e., ketamine hydrochloride or placebo) at the fixed optimum dose (reached during the titration period) for 16 days.
Patients are allowed to receive breakthrough opioids at any time during the study.
Patients complete quality-of-life and pain-assessment questionnaires periodically. Some patients may undergo blood sample collection periodically for pharmacogenomics studies at a later date.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- Double blind
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 |
|---|---|---|
| ketamine hydrochloride | Drug | – |
| pharmacogenomic studies | Other | – |
| questionnaire administration | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Time to treatment failure
7 secondary outcomes
Initial treatment benefit (at day 4 of assessment period of 16 days) using the sensory component of the McGill Short-Form Questionnaire
Difference in overall pain between the study arms based on the visual-analogue score
Difference in neuropathic pain between the study arms based on the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale
Worst pain score (index neuropathic site) in the previous 24 hours (between the two arms) at study baseline and then during study assessment period
Patient distress between the two arms based on NCCN Distress Thermometer
Side effects and tolerability of trial drug
Effect of the intervention on quality-of-life scores (based on Euroqol thermometer), anxiety and depression (based on HAD scale), and opioid requirements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
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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.
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Marie T. Fallon principal investigator
Edinburgh Cancer Centre at Western General Hospital
Barry J.A. Laird, MD principal investigator
Edinburgh Cancer Centre at Western General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketamine hydrochloride, pharmacogenomic studies and questionnaire administration in people with Cancer, run by University of Glasgow at 3 sites in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure. 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 13 May 2011.