Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000378921
Ethics application status
Approved
Date submitted
5/04/2011
Date registered
12/04/2011
Date last updated
11/02/2019
Date data sharing statement initially provided
11/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-reported evaluation of the adverse effects of Dexamethasone (SEED Study)
Scientific title
Self-reported evaluation of the adverse effects of Dexamethasone
Secondary ID [1] 252735 0
N/A
Universal Trial Number (UTN)
U1111-1117-0546
Trial acronym
SEED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain cancer 265610 0
Other cancers that have spread to the brain (brain metastases) 265613 0
Advanced cancer of other types 265619 0
Condition category
Condition code
Cancer 258371 258371 0 0
Brain
Cancer 265764 265764 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is not an interventional study but a feasibility study measuring patient reported outcomes (PROs) in the evaluation of side effects and toxicities from steroid use in patients with brain tumours or brain metastases or advanced cancer. Clinician's will rate patient toxicities from steroid use at baseline using Common Terminology Criteria for Adverse Events version 4. 50 patients will be recruited to the study with at least half (25) having a primary brain tumour (and 50 associated caregivers). The caregivers’ responses are collected in conjunction with those of the patients and are crucial for assessing the reliability of the measurements.

The duration of observation for each patient is 8 weeks with timepoints occuring at baseline, 2, 4 and 8 weeks. At each timepoint, questionnaires are required to be completed.
Intervention code [1] 257252 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259360 0
To test the feasibility of using questionnaires to assess patient, clinician and caregiver rated side effects which may be related to dexamethasone
Timepoint [1] 259360 0
Patients who meet the inclusion criteria and their nominated caregiver will complete the Patient Reported Outcome (PRO) battery which comprises the Dexamethasone Symptom Questionnaire Chronic (DSQ-Chronic), acetazolomide toxicity questionnaire and European Organization for Research and Treatment of Cancer quality of life questionnaire: a shortened questionnaire for cancer patients in palliative care (EORTC QLQ-C15-PAL) at recruitment and again at 2, 4 and 8 weeks. Clinician will assess dexamethasone toxicity using Common Terminology Criteria for Adverse Events (CTCAE) v 4 criteria and rate patient's Karnofsky Performace Status (KPS) at baseline.
Secondary outcome [1] 265842 0
To evaluate the face validity of the DSQ-Chronic by evaluating the rate of completion and participant feedback at structured interview.
Timepoint [1] 265842 0
Paricipants will complete the DSQ-Chronic at baseline and then at 2, 4 and 8 weeks. The structured interview will also take place within 2 weeks after baseline (study start).
Secondary outcome [2] 265843 0
To evaluate the face validity of the acetazolamide toxicity questionnaire by evaluating the rate of completion and participant feedback at structured interview.
Timepoint [2] 265843 0
The acetazolomide questionnaires will be completed by patients at baseline and then at 2, 4 and 8 weeks after baseline.

The structured interview will also take place within 2 weeks after baseline.
Secondary outcome [3] 265844 0
To determine the point prevalence and severity of symptoms which may be attributable to dexamethasone.
Timepoint [3] 265844 0
This aspect concerns the statistical analysis and conclusions made from the data collected at the time points mentioned in the primary outcome (baseline, 2, 4 and 8 weeks)
Secondary outcome [4] 265845 0
To compare patient and caregiver rated dexamethasone related symptoms (prevalence and severity) to establish the likely reliability of proxy rating in future longitudinal interventional studies with participants with progressive brain tumours, some of whom may develop difficulty self-completing due to cognitive impairment
Timepoint [4] 265845 0
This aspect concerns the statistical analysis and conclusions made from the data collected at the time points mentioned in the primary outcome (baseline, 2, 4 and 8 weeks)
Secondary outcome [5] 265846 0
To compare patient and caregiver rated toxicity with clinician rated toxicity using CTCAE v 4 criteria
Timepoint [5] 265846 0
This aspect concerns the statistical analysis and conclusions made from the data collected at the time points mentioned in the primary outcome (baseline, 2, 4 and 8 weeks)
Secondary outcome [6] 265847 0
To assess the rate of recruitment of patients with primary brain tumour to inform the feasibility of phase II study
Timepoint [6] 265847 0
The rate of recruitment will be continually monitored during the course of the study up to completion of the recruitment target.
Secondary outcome [7] 265848 0
To test the feasibility of measuring patient, clinician and caregiver rated side effects which may occur with acetazolamide administration to determine baseline rates of these symptoms.
Timepoint [7] 265848 0
This aspect concerns the statistical analysis and conclusions made from the data collected at the time points mentioned in the primary outcome (baseline, 2, 4 and 8 weeks)
Secondary outcome [8] 265849 0
To assess the rate of recruitment of participants with primary brain tumours, recommenced on dexamethasone (at least 4 mg/day) and on a stable dose for at least 48 hours
Timepoint [8] 265849 0
The rate of recruitment will be continually monitored during the course of the study up to completion of the recruitment target.

Eligibility
Key inclusion criteria
1. Diagnosis of a primary malignant brain tumour, brain metastases or advanced cancer
2. The participants need to have been taking dexamethasone continuously for at least 48 hours
3. For patients with primary brain tumour recommencement of dexamethasone or dose increase to at least 4mg in the last 2 weeks due to progressive raised intracranial pressure in patients and on a stable steroid dose for at least 48 hours with no intention of changing dose for next 48 hours
4. Greater than or equal to 18 years of age
5. Karnofsky performance status (KPS) score of greater than or equal to 40 at baseline
6. Life expectancy of greater than or equal to 8 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinically significant head injury, neurological disorder, chronic seizure disorder or CNS infection, if functional impairment that will interfere with ability to complete assessments;
2. Inability of patient (and caregiver to provide written informed consent;
3. Inability of patient (and caregiver) to complete assessments.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2011
Actual
21/07/2011
Date of last participant enrolment
Anticipated
Actual
17/10/2013
Date of last data collection
Anticipated
Actual
17/12/2013
Sample size
Target
100
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 264864 0
Self funded/Unfunded
Name [1] 264864 0
Country [1] 264864 0
Primary sponsor type
Other
Name
Cooperative Trials Group for Neuro-Oncology (COGNO)
Address
NHMRC Clinical Trials Centre
92-94 Parramatta Rd
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 263966 0
None
Name [1] 263966 0
Address [1] 263966 0
Country [1] 263966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259677 0
Cancer Institute NSW (Cancer Institute NSW Clinical Research Ethics Committee)
Ethics committee address [1] 259677 0
Ethics committee country [1] 259677 0
Australia
Date submitted for ethics approval [1] 259677 0
06/09/2010
Approval date [1] 259677 0
26/11/2010
Ethics approval number [1] 259677 0
HREC/10/CIC/23
Ethics committee name [2] 290725 0
Sydney Local Health District (RPAH Zone)
Ethics committee address [2] 290725 0
Ethics committee country [2] 290725 0
Australia
Date submitted for ethics approval [2] 290725 0
05/09/2013
Approval date [2] 290725 0
14/10/2013
Ethics approval number [2] 290725 0
X13-0180 & HREC/13/RPAH/464

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31648 0
Dr Meera Agar
Address 31648 0
Braeside Hospital Locked Bag 82 Wetherill Park NSW 2164
Country 31648 0
Australia
Phone 31648 0
+61 2 9616-8654
Fax 31648 0
Email 31648 0
Meera.Agar@sswahs.nsw.gov.au
Contact person for public queries
Name 14895 0
SEED Trial Coordinator
Address 14895 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown
NSW 1450
Country 14895 0
Australia
Phone 14895 0
+61 2 9562 5000
Fax 14895 0
+61 2 9562 5094
Email 14895 0
seed@ctc.usyd.edu.au
Contact person for scientific queries
Name 5823 0
Dr Meera Agar
Address 5823 0
Braeside Hospital
Locked Bag 82
Wetherill Park NSW 2164
Country 5823 0
Australia
Phone 5823 0
+61 2 9616-8654
Fax 5823 0
+61 2 9616-8657
Email 5823 0
Meera.Agar@sswahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plans on sharing IPD at this stage.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.