None listed
Conditions
Brief summary
The purpose of this study is to see if a medication called anamorelin improves muscle mass and outcomes in patients with malignant mesothelioma. Who is it for? You may be eligible for this study if you are aged 18 or over, have confirmed malignant mesothelioma and have lost more than 5% of your body weight in 6 months (i.e. ‘cachexia’). Study details Participants will be randomised by chance (like flipping a coin) into two groups. One group will take the active drug anamorelin per day for 28 days, before switching to an inactive placebo medication for another 28 days (after a 3 day break). The other group will follow the same pattern, only they will have the placebo first and then the active medication. Neither the researchers nor participants will know which order the medication/placebo are taken in. As part of this study, all participants will complete a number of questionnaires, a food diary, provide blood samples for testing and have body scans that measure muscle mass. It is hoped this research will show that the medication anamorelin can help patients with malignant mesothelioma maintain or gain weight, which might help them feel better, and shed some insight into body markers of cancer-related weight-loss.
Interventions
Anamorelin (100mg) 1 oral tablet once a day, one hour before food for 28 days
Placebo, 1 oral tablet once a day, one hour before food for 28 days
This is a cross over study, so all participants will receive either the study drug and the placebo for 28 days followed by a washout period of 3 days, then either the study drug or the placebo for another 28 days.
Adherence will be monitored by drug tablet return and review of patient compliance diary.
Sponsors
Institute for Respiratory Health
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
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
Adults (18 years and above) Confirmed malignant pleural mesothelioma (histology or cytology); Cachexia (defined as >5% weight loss in 6 months or < body mass index (BMI) 20 kg/m^2 with weight loss >2%); Life expectancy >3 months at randomisation. Written informed consent ECOG performance status 0-2 (The Eastern Cooperative Oncology Group (ECOG) performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis). At least 3 weeks since last received systemic anticancer therapy Ability to provide written informed consent in English and comply with trial procedures.
Exclusion criteria
Peritoneal spread of mesothelioma Other significant comorbidity or organ dysfunction which may affect outcome measures or safety, Impaired cardiac function or clinically significant cardiac diseases, including any of the following: *History or presence of ventricular tachyarrhythmia *Presence of unstable atrial fibrillation (ventricular response > 120 beats per minute at rest); Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria *Other clinically significant heart disease *Corrected QT interval (QTcF) >480 milliseconds on baseline ECG. If electrolytes are abnormal, they may be corrected and baseline ECGs should be repeated Patients with abnormal liver function tests, defined as any of the following: *Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN), or AST or ALT > 5 times ULN for patients with liver metastases *Total bilirubin > 1.5 x ULN, except for patients with Gilbert’s syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN Participation in another study (drug or non-drug study) that may affect ANTHEM outcome measures, Concurrent chemotherapy or radiotherapy (immunotherapy is accepted), including planned chemo- or radiotherapy commencing during the study period Concurrent use of appetite stimulants including oral corticosteroids (other than for adrenal replacement), mirtazapine (other than for major depressive disorder), or progesterones Patients who are receiving treatment with medications, that cannot be discontinued prior to study entry and that are considered to be any of the following: *known risk for QT prolongation *known to be strong inducers or inhibitors of CYP3A4/5 Uncontrolled diabetes mellitus (defined as random blood glucose >11.1mmol/L and/or HbA1c >7.0%) Significant active gastrointestinal disease (e.g., malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, gastrointestinal perforation, or partial or complete bowel obstruction, ascites of any cause) that might impair absorption of study treatment Inability to readily swallow oral tablets or intractable or frequent vomiting
Outcome results
None listed