CancerDASHNCT01049672
Diamorphine or Alfentanil for Subcutaneous Use in Hospice In-patients?
A study testing Alfentanil and Diamorphine in people with Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
OBJECTIVES: How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in the palliative care setting? STUDY DESIGN: An open-label pilot comparison between alfentanil and diamorphine for palliative care patients who require subcutaneous opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Alfentanil and Diamorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Nov 2014
- Phase
- Interventional
- 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
- To be thought by a hospice doctor to require parenteral strong opioids.
- To have an estimated prognosis of less than 1 year.
Who cannot join
- Inability to read English sufficiently to be able to complete assessment questionnaires.
- Confusion sufficient so that patient is unable to complete questionnaires.
- Weakness or fatigue sufficient so that patient is unable to complete questionnaires.
- Radiotherapy to source of pain in last 4 weeks.
- Change in corticosteroid dose in last week.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sue Ryder Care Leckhampton Court Hospice
Cheltenham, Gloucestershire, GL53 0QJ
About this study
Official title: An Open-label Pilot Comparison Between Alfentanil and Diamorphine for Palliative Care Patients Who Require Subcutaneous Opioids
OBJECTIVES:
How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in the palliative care setting?
STUDY DESIGN:
An open-label pilot comparison between alfentanil and diamorphine for palliative care patients who require subcutaneous opioids.
Read the detailed description
STUDY DESIGN
Study 1 - Open Label Pilot Day - 1 Hospice in-patients who are thought by a clinician to need subcutaneous strong opioids will be asked if they wish to take part in the study.
They will be given a patient information leaflet and a 'cooling off period' (a minimum of 1 day) to think about it. If the clinician feels that strong parenteral opioids are needed diamorphine will be commenced immediately (as standard practice).
Day 0 If the patient agrees to take part in the trial they will be asked to complete a consent form and this will be stored with the patient's notes.
The following assessments will be performed:
- McGill Pain Questionnaire Short Form(MPQ-SF)
- Brief Pain Inventory Short Form (BPI-SF)These measures were recommended by an EAPC Expert Working Group for pain syndrome characterization
- Memorial Delirium Assessment Scale (MDAS). This has been validated in an advanced cancer population and used recently with hospice in-patients.
- Nausea Visual Analogue Scale (VAS)
- Nausea Duration over last 24 hours
- Number of vomits in previous 24 hours
Randomisation Once baseline measures are completed the participant will be randomised using the next available of a series of numbered, opaque, sealed envelopes. These will be prepared remotely. Blocking will be used to prevent an imbalance in terms of the number allocated to each group. Block size will be appropriate to the size of the study and not be divulged to the investigators responsible for consent and revealing the allocation. This will reduce the risk of investigators anticipating the allocation for particular patients. A study log will be kept on site where participant details will be completed before the envelope is opened.
Subsequent Days
On each subsequent day the following assessments will be performed:
- BPI-SF
- MDAS
- Nausea VAS
- Number of vomits in previous 24 hours In addition the following measurements will be taken:
- Stool chart for previous 24 hours
- Breakthrough medication (number of doses and dosage) used
- Laxatives taken
- Other changes to medication
Patients will cease participation after assessment on day 7.
- Conditions
- Cancer
- Being tested
- Alfentanil, Diamorphine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfentanilDrug
Titrated to a maximum dose of 50mg in 24 hours subcutaneously
DiamorphineDrug
Titrated to a maximum dose of 500mg in 24 hours given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Alfentanil | Active comparator | Hospice in-patients who require subcutaneous strong opioid administration will be given alfentanil Receives: Drug: Alfentanil |
| Diamorphine | Active comparator | Hospice in-patients who require strong opioids will be given diamorphine Receives: Drug: Diamorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in MDAS will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Measured: day 3
Secondary outcomes (10)
Change in MDAS between Days 0 and 7
The change in MDAS will be calculated from day 0 to day 7 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Measured: Day 7
The change in the BPI-SF
The change in BPI-SF will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Measured: Day 3
The change in BPI-SF
The change in BPI-SF will be calculated from day 0 to day 7 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Measured: Day 7
The difference in proportion of patients taking laxatives
The difference in proportion of patients taking laxatives will be compared between the two groups using the confidence interval on the difference of two proportions.
Measured: Day 7
The change in nausea visual analogue scale
The change in nausea visual analogue scale will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Measured: Day 3
Change in the number of vomits
The change in number of vomits will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Measured: Day3
Change in nausea visual analogue scale
The change in nausea visual analogue scale will be calculated from day 0 to day 7 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-WhitneyU test otherwise
Measured: Day 7
Change in the number of vomits
The change in number of vomits will be calculated from day 0 to day 7 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Measured: Day 7
Change in the total dosage of breakthrough medication (number of doses x dosage)
The change in the total dosage of breakthrough medication will be calculated from day 0 to day 3 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-WhitneyU test otherwise
Measured: Day 3
Change in the total dosage of breakthrough medication (number of doses x dosage)
The change in the total dosage of breakthrough medication will be calculated from day 0 to day 7 and compared betwen the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-WhitneyU test otherwise
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2014
- Study completionNov 2014
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Perkins, Gloucestershire Hospitals NHS Foundation Trust
- Investigators
- Paul Perkins, MBBCh FRCP, Principal investigator, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049672
- Sponsor's protocol ID
- 07/Q0104/47
- Acronym
- DASH
- Status last verified
- Mar 2015
- First submitted
- 13 Jan 2010
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pilot Comparison Between Alfentanil and Diamorphine for Palliative Care Patients Who Require Subcutaneous Opioids
- ClinicalTrials.gov ID
- NCT01049672
- Acronym / sponsor ID
- DASH / 07/Q0104/47
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Jan 2010 (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.
OBJECTIVES:
How does Alfentanil compare with the standard drug Diamorphine for subcutaneous analgesia in the palliative care setting?
STUDY DESIGN:
An open-label pilot comparison between alfentanil and diamorphine for palliative care patients who require subcutaneous opioids.
Detailed description
STUDY DESIGN
Study 1 - Open Label Pilot Day - 1 Hospice in-patients who are thought by a clinician to need subcutaneous strong opioids will be asked if they wish to take part in the study.
They will be given a patient information leaflet and a 'cooling off period' (a minimum of 1 day) to think about it. If the clinician feels that strong parenteral opioids are needed diamorphine will be commenced immediately (as standard practice).
Day 0 If the patient agrees to take part in the trial they will be asked to complete a consent form and this will be stored with the patient's notes.
The following assessments will be performed:
- McGill Pain Questionnaire Short Form(MPQ-SF)
- Brief Pain Inventory Short Form (BPI-SF)These measures were recommended by an EAPC Expert Working Group for pain syndrome characterization
- Memorial Delirium Assessment Scale (MDAS). This has been validated in an advanced cancer population and used recently with hospice in-patients.
- Nausea Visual Analogue Scale (VAS)
- Nausea Duration over last 24 hours
- Number of vomits in previous 24 hours
Randomisation Once baseline measures are completed the participant will be randomised using the next available of a series of numbered, opaque, sealed envelopes. These will be prepared remotely. Blocking will be used to prevent an imbalance in terms of the number allocated to each group. Block size will be appropriate to the size of the study and not be divulged to the investigators responsible for consent and revealing the allocation. This will reduce the risk of investigators anticipating the allocation for particular patients. A study log will be kept on site where participant details will be completed before the envelope is opened.
Subsequent Days
On each subsequent day the following assessments will be performed:
- BPI-SF
- MDAS
- Nausea VAS
- Number of vomits in previous 24 hours In addition the following measurements will be taken:
- Stool chart for previous 24 hours
- Breakthrough medication (number of doses and dosage) used
- Laxatives taken
- Other changes to medication
Patients will cease participation after assessment on day 7.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfentanil | Active comparator | Drug: AlfentanilHospice in-patients who require subcutaneous strong opioid administration will be given alfentanil |
| Diamorphine | Active comparator | Drug: DiamorphineHospice in-patients who require strong opioids will be given diamorphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be thought by a hospice doctor to require parenteral strong opioids.
- To have an estimated prognosis of less than 1 year.
Key exclusion criteria (5 listed)
- Inability to read English sufficiently to be able to complete assessment questionnaires.
- Confusion sufficient so that patient is unable to complete questionnaires.
- Weakness or fatigue sufficient so that patient is unable to complete questionnaires.
- Radiotherapy to source of pain in last 4 weeks.
- Change in corticosteroid dose in last week.
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 |
|---|---|---|
| AlfentanilTitrated to a maximum dose of 50mg in 24 hours subcutaneously | Drug | Alfentanil |
| DiamorphineTitrated to a maximum dose of 500mg in 24 hours given subcutaneously | Drug | Diamorphine |
Primary outcome
The change in MDAS will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise.
Time frame: day 3
10 secondary outcomes
Change in MDAS between Days 0 and 7
Time frame: Day 7
The change in the BPI-SF
Time frame: Day 3
The change in BPI-SF
Time frame: Day 7
The difference in proportion of patients taking laxatives
Time frame: Day 7
The change in nausea visual analogue scale
Time frame: Day 3
Change in the number of vomits
Time frame: Day3
Change in nausea visual analogue scale
Time frame: Day 7
Change in the number of vomits
Time frame: Day 7
Change in the total dosage of breakthrough medication (number of doses x dosage)
Time frame: Day 3
Change in the total dosage of breakthrough medication (number of doses x dosage)
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
Paul Perkins, MBBCh FRCP principal investigator
Gloucestershire Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alfentanil and Diamorphine in people with Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site 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?
The sponsor lists 2 inclusion and 5 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: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change in MDAS will be calculated from day 0 to day 3 and compared between the two groups using a t-test if the data are sufficiently normally distributed, or the Mann-Whitney U test otherwise. (time frame: day 3). 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 17 Mar 2015.