Randomised, double blind control trial of megestrol acetate, dexamethasone and placebo in the management of anorexia in people with cancer
- Conditions
- AnorexiaCancer - Other cancer types
- Registration Number
- ACTRN12608000405314
- Lead Sponsor
- Flinders University
- Brief Summary
This study compared megestrol acetate 480 mg/day with dexamethasone 4 mg/day for the overall effects on appetite. Patients with advanced cancer and anorexia for 2 weeks with a score of 4 out of 10 (using a 0-10 numeric rating scale (NRS) where 0 = no appetite, and 10 = best possible appetite) were recruited. Participants received megestrol 480 mg or dexamethasone 4 mg or placebo daily for up to 4 weeks. The primary outcomes were measured on day 7. People who responded to the treatment were defined as having a 25% improvement in appetite score from the baseline score, where the score for appetite at baseline was expected to score higher. There were 190 people randomised (megestrol acetate n = 61; dexamethasone n = 67, placebo n = 62). At week 1 (primary endpoint), 79·3% in the megestrol group, 65·5% in the dexamethasone group and 58·5% in the placebo group (p = 0.067) had responded, that is these people had shown a 25% improvement in the score for appetite. No differences in performance status or quality of life were reported. Adverse events (side effects) that emerged while on one of the 3 treatments were frequent (90·4% of all participants), and included altered mood and insomnia. Changes to blood sugar levels and occurrence of blood clots in deep veins were more frequent for those people taking dexamethasone than the other two arms. There was no difference seen between the three arms, with no benefit seen over placebo with anorexia shown to improve in all 3 arms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 163
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in appetite score on a Numeric Rating Scale for appetite at 1 week, with response defined as 25% increase in the baseline score.[At baseline and at one week after intervention commencement]
- Secondary Outcome Measures
Name Time Method