Randomised, double blind control trial of megestrol acetate, dexamethasone and placebo in the management of anorexia in people with cancer
Cancer Symptom Trials (CST)Dataset description
Data set includes: - One hundred and ninety participants were included in intention-to-treat analysis (61 receiving megestrol acetate, 67 receiving dexamethasone, and 62 receiving placebo) The treatment period was for four weeks whilst outpatient, with an optional extension for a further 4 weeks (still blinded), with four weeks of follow-up post treatment. Data available for Patient demographic information, medical history data, concurrent medications and baseline clinical measures. Primary outcome data measured as a change in appetite score on a Numeric Rating Scale for appetite at 1 week, at baseline and at one week after intervention commencement. Other data includes: Patient weight and rate of weight change (measured by Body Mass Index) At baseline and at one week after intervention commencement; Short and intermediate adverse effect profiles of megestrol acetate and dexamethasone using the National Institutes of Health Common Terminology Criteria for Adverse Event Assessment V3.0. At baseline and four weeks after intervention commencement; Relative costs of treatment of dexamethasone and megestrol acetate using Medicare Data 4 weeks after treatment commencement; Quality of life (measured by the European organization for Research and Treatment of Cancer- Quality of Life Questionnaire- core questions and the Functional assessment of appetite in cancer therapy) at baseline and 1 week after treatment commencement; Functional status (measured by the Australian Modified Karnofsky Performance Status, and the Eastern Co-operative Oncology Group scales) at baseline and 1 week after treatment commencementSubjects
Clinical sciences not elsewhere classified |Identifiers
Source Study
Trial name (public)
Randomised, double blind control trial of megestrol acetate, dexamethasone and placebo in the management of anorexia in people with cancerTrial acronym
Megestrol, dexamethasone and placebo for anorexia.
Trial ID
ACTRN12608000405314
Purpose
Treatment
Phase
Phase 3
Funding
Government body,Commonwealth Department of Health and Ageing
Scientific enquiries
Prof David Currow
Brief Summary
This study looks at the effectiveness of the appetite stimulating drugs megestrol and dexamethasone in treating anorexia in the palliative care of people with widespread and advanced cancer. Who is it for? You can join this study if you have widespread and advanced cancer and suffer from loss of appetite. Trial details Participants will be divided into two groups. One group will receive the drug megestrol acetate and the other will receive dexamethasone. Both groups will be monitored for appetit .... Read more
Key Inclusion Criteria
Age: 18 years and above Able to speak English (or have an interpreter available) to complete all assessments Mentally competent: Able to understand the information given and to provide informed consent Able to reliably take oral medication and has an intact gastrointestinal tract. Diagnosis of cancer. Clinical prediction of survival: > 6 weeks Functional performance status: ECOG (Eastern Co-operative Oncology Group) 0-3 or AKPS (Australian Modified Karnofsky Performance Status) 40-100
Key Exclusion Criteria
History of thromboembolic disease without adequate anti-coagulation, Concurrent corticosteroids or progestogens. Previous adverse reaction to megestrol acetate or dexamethasone Concurrent androgens, cannabinoids, olanzepine or other psychostimulants (antidepressants or anti-psychotics) being used primarily for appetite stimulation. Tube feedings or parenteral nutrition Clinically significant evidence of ascites (i.e. shifting dullness on physical examination) or pleural effusions Poorly controll .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 163
Min. age 18 Years
Max. age 0 No limit
Sex Both males and females
Condition category Anorexia
Condition code Cancer
Intervention
Intervention code Treatment: Drugs
Double blind, placebo controlled, randomized Phase III trial of 3 arms: megestrol acetate 480 mg/day vs. Dexamethasone 4 mg/day vs. placebo for up to 4 weeks according to weekly response assessment for appetite.
Comparison
Control group Placebo
Capsules containing cornstarch, manufactured to look identical to the interventions
Outcomes
Outcome: Change in appetite score on a Numeric Rating Scale for appetite at 1 week, with response defined as 25% increase in the baseline score.Timepoint: At baseline and at one week after intervention commencement
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Data related to demographics and baseline medical conditions, data related to primary and secondary outcomes
When will data be available?
From 1st June 2023 to 1st June 2030
Available to whom?
Other researchers with research question approved by the study investigator team
Available for what types of analyses?
Those analyses described in approved proposals only