None listed
Conditions
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.
Interventions
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
Sponsors
Palliative Care Clinical Studies Collaborative
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed