Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001336572
Ethics application status
Approved
Date submitted
18/11/2015
Date registered
8/12/2015
Date last updated
2/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
To determine the feasibility of conducting a study of oral dexamethasone at a dose of 8mg daily in conjunction with opioids and standard adjuvant therapy, in the management of uncontrolled pain related to cancer or its treatment.
Scientific title
CAncer DExamethasone Trial (CADET) Part 1: A multi-centre single-arm, feasibility study of oral dexamethasone in the management of cancer-related pain
Secondary ID [1] 287916 0
None
Universal Trial Number (UTN)
U1111-1176-6271
Trial acronym
CADET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer pain 296800 0
Palliative care 296801 0
Condition category
Condition code
Cancer 297028 297028 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single arm study of dexamethasone 8mg oral daily for 5 days
Drug usage will be monitored by tablet return at the completion of the intervention phase
Intervention code [1] 293273 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296627 0
The primary purpose of this pilot study is to assess feasibility. The co-primary feasibility outcomes will be: 1) enrollment of 20 patients across four sites in six months, and 2) at least 60% of enrolled patients progressing to study completion.
Timepoint [1] 296627 0
6 months after commencement of trial
Secondary outcome [1] 318950 0
Feasibility:
Feasibility outcomes will measure additional processes, resource and management factors associated with undertaking the research.
Staff time spent administering the intervention will be documented in the Clinical Research File.
Timepoint [1] 318950 0
6 months after commencement of study
Secondary outcome [2] 318996 0
Efficacy:
To obtain preliminary data on the efficacy of the addition of oral dexamethasone to optimise opioid therapy on cancer pain
This will be assessed using the Brief pain inventory tool at baseline, visits days 2-6 and visit 14
Concurrent medication use including co-analgesics will be assessed each visit. This will be assessed at baseline, days 2-6 and day 14. For inpatients the medication chart will be reviewed at these time points. For outpatients patients will self report use to study staff at these study visits
Timepoint [2] 318996 0
The Brief Pain Inventory measurement will be administered at baseline, days 2-6 and day 14 to assess changes over the intervention period
Secondary outcome [3] 319090 0
Adverse events:
Symptoms will be identified at baseline, days 2-6 and day 14 using criteria established by the National Cancer Institute, and will be graded accordingly. Specifically for this study, the symptoms of interest will be;
Abnormally elevated mood, irritability, accelerated speech or activity, flight of thought, psychosis, confusion, anxiety, depression. These will be evaluated at baseline, days 2-6 and day 14 with the ESAS and study staff assessment and patient self reporting.
Symptomatic hypoglycemia which will be monitored by random BSL at baseline and then according to site specific institution guidelines.
Increased peripheral oedema will be assessed by study staff and patient self reporting of symptoms at baseline, days 2-6 and day 14.
Dyspepsia and/or other evidence of gastric mucosa damage assessed at baseline, days 2-6 and day 14 by patient self-reporting of symptoms and study staff assessment of patient.
Oral candidiasis will be assessed by oral examination by study staff at baseline, days 2-6 and day 14.
Timepoint [3] 319090 0
Adverse events will be recorded using the Common Terminology Criteria for Adverse Events (CTCAE) criteria at baseline, days 2-6 and day 14.
A grade of 3 (that has not responded to symptomatic treatment instituted by the treating physician according to local protocols) or 4 will activate cessation of study intervention and an adverse event report.
Any Serious Adverse Events will be reported to the independent medical monitor for review as per ICH GCP guidelines.
All adverse events will be collated by the project officer, and reported to the executive committee on a monthly basis.
Secondary outcome [4] 319294 0
Opioid dose
To obtain preliminary data on the effect of oral dexamethasone on total opioid dose during and after the intervention period
For in-patients study staff will review the medication chart at baseline, days 2-6 and day 14 for total morphine equivalency and number of breakthrough doses taken.
For patients at home they will self report total opioid consumption at baseline, day 2-6 and day 14.
Timepoint [4] 319294 0
Background opioid use will be recorded at each study visit and any rescue medication (additional opioid breakthrough medication) will be recorded at each study visit
These will be recorded at baseline, days 2-6 and day 14 visits.

Eligibility
Key inclusion criteria
Age greater than 18 years
Pain related to cancer or its treatment
Brief Pain Inventory form (BPI-SF) average pain score >= 3/10 in the previous 24 hours
No increase in baseline opioid dose or co-analgesics within 48 hours before study entry, or planned increase during the study
Participant is capable of completing assessments and complying with the study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients currently taking corticosteroids or who have taken corticosteroids within the previous seven days
Previous adverse reaction to dexamethasone
Patient unable to swallow oral medications
Patients scheduled to receive radiotherapy for pain or commencing a new chemotherapy/targeted therapy/hormonal therapy or other therapies/intervention if there is a realistic expectation of that therapy affecting pain
Any patient following major surgery where wound-healing is still occurring
Patients with clinician assessed unstable diabetes mellitus
Any patient with recent upper gastrointestinal bleeding or uncontrolled gastro-oesophageal reflux disease
Medically assessed history of systolic blood pressure >= 180 mmHg and/or dystolic blood pressure >= 110 mmHg, uncontrolled cardiac failure, marked fluid retention, acute sepsis
Patients with systemic fungal infections or recent vaccination with live virus
Patients with documented history of bipolar disorder, schizophrenia or severe anxiety or depression. Patients with evidence of psychosis or significant anxiety at time of trial commencement
Patients currently taking Non-steroidal Anti-inflammatory Drugs (NSAIDS) or who have taken NSAIDS within 3 days of trial commencement
Women who are pregnant or lactating. Patients at risk of pregnancy must have appropriate and effective contraceptive in place (or appropriate advice from their doctor regarding appropriate birth control)
Patients who have participated in a clinical study of a new chemical entity within the last month, prior to study entry

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this feasibility study will be 20 participants. Data will be summarised by descriptive statistics. Frequency counts and percentages will be used to summarise categorical variables, and mean (standard deviation) or median (interquartile range) for continuous variables. The feasibility of proceeding to a phase III trial will be determined by the outcomes of this pilot study.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
25/01/2016
Actual
12/02/2016
Date of last participant enrolment
Anticipated
29/07/2016
Actual
3/05/2017
Date of last data collection
Anticipated
Actual
25/05/2017
Sample size
Target
20
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 4675 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 4677 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [3] 4678 0
Barwon Health - McKellar Centre campus - North Geelong
Recruitment hospital [4] 4679 0
Repatriation Hospital - Daw Park
Recruitment hospital [5] 4680 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 4681 0
Noarlunga Health Service - Noarlunga Centre
Recruitment postcode(s) [1] 12256 0
3050 - Royal Melbourne Hospital
Recruitment postcode(s) [2] 12257 0
3065 - Fitzroy
Recruitment postcode(s) [3] 12258 0
3215 - Geelong North
Recruitment postcode(s) [4] 12259 0
5041 - Daw Park
Recruitment postcode(s) [5] 12260 0
5042 - Flinders University
Recruitment postcode(s) [6] 12261 0
5168 - Noarlunga Centre

Funding & Sponsors
Funding source category [1] 292406 0
Other Collaborative groups
Name [1] 292406 0
Palliative Care Clinical Studies Collaborative
Country [1] 292406 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Palliative Care Clinical Studies Collaborative
Address
Flinders University
Department of Palliative and Supportive Services
700 Goodward Rd
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 291089 0
None
Name [1] 291089 0
None
Address [1] 291089 0
Country [1] 291089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293874 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 293874 0
PO Royal Melbourne Hospital
Parkville Victoria 3050
Ethics committee country [1] 293874 0
Australia
Date submitted for ethics approval [1] 293874 0
14/10/2015
Approval date [1] 293874 0
16/11/2015
Ethics approval number [1] 293874 0
HREC/15/MH/298

Summary
Brief summary
The purpose of this pilot study is to assess the feasibility of conducting a larger Phase III study. The outcomes that will be measured to assess whether the trial is successful are 1) enrollment of 20 patients across 4 sites in six months, and 2) at lease 60% of enrolled patients progressing to study completion. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are experiencing pain related to cancer or it’s treatment with an average pain score of 3/10 or greater on the Brief Pain Inventory-short form (BPI-SF) in previous 24 hours. Study details: Participants in this study will all receive dexamethasone oral 8mg daily for 5 days. Participants concurrent medication use, background opioid use, co-analgesics, any rescue medication, The Edmonton Symptom Assessment System score, Brief Pain Inventory, Australian Karnofsky Performance Scale, EORTC QLQ-C30/15 will be collected by the research nurse following review of the patient each day of study intervention. The patients global impression of change will be collected on D6 and follow up D14 visit. Many doctors believe dexamethasone is helpful in relieving cancer related pain and it has been used in this way, in addition to strong pain medications, for many years. However, there is limited clinical evidence to support this use of dexamethasone, which is why this study is being conducted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61594 0
Dr Peter Eastman
Address 61594 0
Department of Palliative and Supportive Care
Royal Melbourne Hospital
Grattan Street, Parkville VIC 3050
Country 61594 0
Australia
Phone 61594 0
+61 3 9342 7820
Fax 61594 0
+61 3 93424928
Email 61594 0
[email protected]
Contact person for public queries
Name 61595 0
Peter Eastman
Address 61595 0
Department of Palliative and Supportive Care
Royal Melbourne Hospital
Grattan Street, Parkville VIC 3050
Country 61595 0
Australia
Phone 61595 0
+61 3 9342 7820
Fax 61595 0
+61 3 93424928
Email 61595 0
[email protected]
Contact person for scientific queries
Name 61596 0
Peter Eastman
Address 61596 0
Department of Palliative and Supportive Care
Royal Melbourne Hospital
Grattan Street, Parkville VIC 3050
Country 61596 0
Australia
Phone 61596 0
+61 3 9342 7820
Fax 61596 0
+61 3 93424928
Email 61596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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