None listed
Conditions
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 appetite levels and quality of life, along with any weight gain, improved function and side effects. Despite encouraging results from a US study, megestrol is not currently prescribed extensively as an appetite stimulant to Australians with advanced cancer, primarily due to its cost.
Interventions
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.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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 controlled congestive heart failure: ejection fraction (<20%, measured in past 6 months) or NYHA (New York Heart Foundation) class IV Severe hypertension Patients with vascular access devices (e.g Portacaths) who are not having prophylactic anticoagulation Diabetes controlled by diet and/or oral medication Pregnant or nursing Active systemic infection at the start of treatment Diarrhoea as defined by 5 or more watery stools per day for at least 7 days.
Outcome results
None listed