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 commencement
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Source Study

Trial acronym

Megestrol, dexamethasone and placebo for anorexia.

Trial ID





Phase 3


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 ....
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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 ....
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Can healthy volunteers participate?




Sample Size    163

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Anorexia

Condition code    Cancer


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.


Control group Placebo

Capsules containing cornstarch, manufactured to look identical to the interventions


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

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


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

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see