Megestrol, dexamethasone and placebo for anorexia.
ACTRN12608000405314
Treatment
Phase 3
Government body,Commonwealth Department of Health and Ageing
Prof David Currow
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
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
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
No
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
yes
Data related to demographics and baseline medical conditions, data related to primary and secondary outcomes
From 1st June 2023 to 1st June 2030
Other researchers with research question approved by the study investigator team
Those analyses described in approved proposals only