Self-reported evaluation of the adverse effects of Dexamethasone (SEED Study)

Not Applicable

Completed

• Conditions: Brain cancer; Other cancers that have spread to the brain (brain metastases); Advanced cancer of other types; Cancer - Brain; Cancer - Other cancer types

• Registration Number: ACTRN12611000378921
• Lead Sponsor: Cooperative Trials Group for Neuro-Oncology (COGNO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-12
• Study Completion: 2013-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test the feasibility of using questionnaires to assess patient, clinician and caregiver rated side effects which may be related to dexamethasone[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.]