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Trial registered on ANZCTR


Registration number
ACTRN12615000087550
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
3/02/2015
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study for the addition of parenteral dexamethasone to concurrent opioid therapy in patients with cancer related pain.
Scientific title
A recruitment feasibility study on the addition of dexamethasone to concurrent opioid therapy in patients with suboptimal cancer related pain management despite standard therapy.
Secondary ID [1] 286013 0
NIL
Universal Trial Number (UTN)
N/A
Trial acronym
Parenteral dexamethasone for cancer
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ongoing cancer related pain despite standard therapy. 293976 0
Condition category
Condition code
Cancer 294276 294276 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexamethasone 8mgs parenteral, daily for five days (intravenous or subcutaneous) or placebo. Routine blood test prior to commencement. Return of syringes/study drug with patient diary.
Route of administration is determined by the participants current medical management. If they have intravenous access of any kind for routine care, the study drug will be given intravenously. All other participants will have the drug given subcutaneously through a subcutaneous butterfly set to minimise invasive and more painful measures.
Intervention code [1] 290991 0
Treatment: Drugs
Comparator / control treatment
Placebo - Normal Saline, daily for 5 days parenteral
Control group
Placebo

Outcomes
Primary outcome [1] 294071 0
Percentage of randomised patients who progress to complete study (feasibility to proceed to phase III will be defined as at least 60% completion of study intervention and measurements).
Timepoint [1] 294071 0
Day 6 and day 14
Secondary outcome [1] 312464 0
Efficacy: Brief Pain Inventory average and worst pain score
Timepoint [1] 312464 0
baseline, days 2-6 and 14

Secondary outcome [2] 312615 0
Quality of Life assessment (EORTC QLQ C15)
Timepoint [2] 312615 0
baseline, day 6 and day 14
Secondary outcome [3] 312616 0
Australian Modified Karnofsky Performance Status
Timepoint [3] 312616 0
(baseline, day 6 and 14)
Secondary outcome [4] 312617 0
Patient Global Impression of Change
Timepoint [4] 312617 0
(day 6 and day 14)
Secondary outcome [5] 312618 0
Total opioid dose received per 24 hours in oral morphine equivalent,
Timepoint [5] 312618 0
baseline, Day 2 to Day 6, and day 14
Secondary outcome [6] 312619 0
Overall survival from start of study
Timepoint [6] 312619 0
Approximately six months or until data collection ceases.
Secondary outcome [7] 312620 0
Toxicity: Adverse Events (NCI-TCAEs)
Timepoint [7] 312620 0
Baseline, day1-6, and day 14.
Secondary outcome [8] 312621 0
Use of breakthrough opioid analgesia

Timepoint [8] 312621 0
baseline, days 1-14.

Eligibility
Key inclusion criteria
1. age > 18 years
2. pain related to cancer or its treatment
3. Brief Pain Inventory-short form (BPI-SF) average pain score greater than or equal to 3 in the previous 24 hours
4. patients with primarily nociceptive pain (defined as Leeds Assessment of Neuropathic Symptoms and Signs score (LANSS) <12), must have received opioids for at least 48 hours, at or greater than 40mg of oral morphine equivalent per day, unless contraindicated.
5. patients with predominantly neuropathic pain (LANSS greater than or equal to 12) must have received opioids and at least one antidepressant and/or anticonvulsant for at least 48 hours unless the non-opioid analgesic is specifically contraindicated
6. no increase in baseline opioid dose within 48 hours before study entry, or planned increase during the study
7. no increase in co-analgesics within 48 hours of study entry or planned during the duration
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Concurrent corticosteroids or use within 7 days of study
2. Clinician predicted survival less than 28 days
3. Patients due to receive radiotherapy during or within 4 weeks of study entry
4. Patients due to commence other therapies during the study period which in the opinion of the investigator may affect pain, including surgery, anaesthetic procedures and chemotherapy.
5. Medically assessed history of uncontrolled hypertension, uncontrolled cardiac failure, marked fluid retention, or acute sepsis with haemodynamic compromise
6. Patients with documented uncontrolled diabetes mellitus or active peptic ulcer disease
7. Patients with documented history of uncontrolled bipolar disorder, schizophrenia, moderate to severe anxiety or depression or a history of steroid induced psychosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The clinical trials pharmacy is responsible for the allocation of treatment arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study with a sample size of twenty will use a simple computerised randomisation method. The study will be blinded with two groups – dexamethasone group vs a control group with a ratio of 1:1. The clinical trials pharmacist will be responsible for holding the randomisation schedule and for allocating participants to their group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Given this is a pilot study a target number of 20 participants were chosen to provide enough information about the feasibility to recruit patients to this trial, as well as giving an indication of dropouts.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3353 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 3354 0
Mater Private Hospital - South Brisbane
Recruitment hospital [3] 3355 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment postcode(s) [1] 9132 0
4101 - South Brisbane
Recruitment postcode(s) [2] 9153 0
4169 - Kangaroo Point

Funding & Sponsors
Funding source category [1] 290609 0
Hospital
Name [1] 290609 0
Mater Research Early Career Researcher Seeding Grant The Mater Misericordiae Ltd (The Mater Hospital Brisbane)
Address [1] 290609 0
Raymond Terrace
South Brisbane, QLD, 4101
Country [1] 290609 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Ltd
Address
Raymond Terrace
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 289295 0
None
Name [1] 289295 0
Address [1] 289295 0
Country [1] 289295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292240 0
Mater Misericordiae Ltd Human Research Ethics Committee (MML HREC)
Ethics committee address [1] 292240 0
Room 294, Level 2, Aubigny Place
Raymond Terrace
South Brisbane
QLD 4101
Ethics committee country [1] 292240 0
Australia
Date submitted for ethics approval [1] 292240 0
12/01/2015
Approval date [1] 292240 0
23/04/2015
Ethics approval number [1] 292240 0
NIL

Summary
Brief summary
This study aims to find out how achievable it is to find participants for a trial that involves cancer patients whom despite taking recommended pain relief medications continue to experience problems with pain management, and add either dexamethasone or placebo to their usual medications and evaluate the response. Who is it for? You may be eligible to join this study if you are aged greater than 18 years and continue to experience pain related to cancer or its treatment, despite taking recommended pain relief medications. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive daily injections of a steroid medication known as dexamethasone for 5 days. The injection will either be administered intravenously (i.e. directly into the vein) or subcutaneously (i.e. into the skin). Participants in the other group will receive daily saline injections instead. Saline is an inactive (placebo) treatment. Participants will not know which group they are in until the end of the study. All participants will be asked to complete a number of questionnaires over a period of 14 days in order to evaluate their pain levels and quality of life. Total opioid dose received, overall survival and the occurrence of any adverse events will also be recorded. Data collected from this study will help us determine how achievable it is to proceed to conduct a larger trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54250 0
Dr Philllip Good
Address 54250 0
The Mater Misericordiae Ltd, Raymond Terrace South Brisbane, QLD, 4101
Country 54250 0
Australia
Phone 54250 0
+617 31633884
Fax 54250 0
+617 31632701
Email 54250 0
phillip.good@mater.org.au
Contact person for public queries
Name 54251 0
Miss Georgie Cupples
Address 54251 0
Mater Misericordiae Ltd, Raymond Terrace South Brisbane, QLD 4101
Country 54251 0
Australia
Phone 54251 0
+617 31633884
Fax 54251 0
+617 31631588
Email 54251 0
Georgie.Cupples@mater.org.au
Contact person for scientific queries
Name 54252 0
Dr Philllip Good
Address 54252 0
Mater Misericordiae Ltd, Raymond Terrace South Brisbane, QLD, 4101
Country 54252 0
Australia
Phone 54252 0
+617 31633884
Fax 54252 0
+617 31632701
Email 54252 0
phillip.good@mater.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary