Table 2 Clinical trials of drugs to ameliorate cancer cachexia. Data from www.clinicaltrials.gov
From: Cancer cachexia: molecular mechanisms and treatment strategies
Compound/drug | Target/agent | Phase | NCT number | Location | Status | Treatment outcomes |
|---|---|---|---|---|---|---|
Megestrol acetate | Appetite stimulant | III | NCT00002067 | USA | Completed | Maximal weight gain was normally achieved within 8Â weeks. Unfortunately, the weight gain was mainly due to an increase in fat mass and partly due to edema. No significant effects were reported as regards the Karnofsky index |
| Â | Â | II | NCT00002300 | USA | Completed | |
Ghrelin/Anamorelin HCl | Appetite stimulant | II | NCT01505764 | USA | Terminated | Terminated due to poor recruitment (10 subjects were consented, 9 received drug or placebo, 5 completed the study) |
|  |  | I/II | NCT00933361 | Switzerland | Completed | No grade 3/4 toxicity or stimulation of tumor growth was observed. Ghrelin is well tolerated and safe in patients with advanced cancer. No difference was observed between the lower- and upper-dose group for safety, tolerance, and patients’ preference for treatment |
|  |  | III | NCT01387282 | USA | Completed | No differences in grade 3–4 treatment-related adverse events between study groups; the most common grade 3–4 adverse event was hyperglycemia |
| Â | Â | III | NCT01387269 | USA | Completed | |
RC-1291 | Ghrelin receptor agonist | II | NCT00267358 | USA | Completed | 74 patients were eligible for the efficacy analyses. Lean body mass increased in 38 patients in the anamorelin group compared with 36 patients in the placebo group after 12 weeks of the treatment. 42 patients (95%) treated with anamorelin and 33 patients (87%) treated with placebo had adverse events. The most common grade 3–4 adverse events (treatment-related or not) in the anamorelin group were fatigue, asthenia, atrial fibrillation, and dyspnea; in the placebo group, such events were pneumonia and anemia, thrombocytopenia, abdominal pain, anxiety, and dyspnea |
| Â | Â | II | NCT00378131 | USA | Completed | Not available |
Sun11031 | Synthetic Ghrelin | II | NCT00698828 | Japan | Completed | Not available |
BYM338 | Myostatin | II | NCT01669174 | USA | Completed | BYM338 treatment safely increased skeletal muscle mass but did not improve functional capacity in patients with COPD and low muscle mass. Thigh muscle volume increased at week 4 and remained increased at week 24 in BYM338-treated patients, whereas no changes were observed with placebo. Adverse events in the BYM338 group included muscle-related symptoms, diarrhea, and acne, most of which were mild in severity |
Eicosapentaenoic Acid | EPA | Not applicable | NCT00815685 | USA | Completed | Not available |
NGM120 | GDF15 receptor GFRAIL | I | NCT03392116 | Australia | Completed | Not available |
PF-06946860 (Ponsegromab) | GDF15 | I | NCT04299048 | USA | Active, not recruiting | Not available |
GSK2881078 (SARM) | Androgen receptor | II | NCT03359473 | USA | Completed | GSK2881078 was well tolerated, and short-term treatment increased leg strength, when expressed as percent predicted, in men with COPD more than the physical training alone |
APD209 | Androgen metabolism | II | NCT00895726 | UK | Completed | Not available |
MT0-102 | ß-adrenergic | II | NCT01238107 | India | Completed | Not available |
VT-122 | ß-adrenergic | II | NCT00527319 | India | Completed | Not available |
ALD518 | IL-6 | II | NCT00866970 | UK | Completed | Not available |
Ruxolitinib | JAK/STAT | Early phase I | NCT04906746 | USA | Not yet recruiting | Not available |
| Â | Â | II | NCT02072057 | Switzerland | Terminated | Not available |
Curcumin | NF-kB | II | NCT04208334 | Thailand | Completed | Not available |
Insulatard, flexpen | Insulin | IV | NCT00329615 | Sweden | Completed | The total diet energy density did not predict energy balance. Survival was positively, and systemic inflammation negatively associated with energy balance. Only energy intake remained a significant predictor of energy balance after adjustment for survival and inflammatory status |
PPP011/CAUM | Cannabis | III | NCT04001010 | Canada | Suspended | Not available |
Kanglaite | Natural compound | Â | NCT03631459 | Beijing | Unknown | Not available |
N-acetylcysteine | antioxidant | II | NCT00196885 | Germany | Completed | N-Acetylcysteine treatment strongly enhanced the increase in knee extensor strength and significantly increased the sum of all strength parameters if adjusted for baseline arginine level as a confounding parameter. N-acetylcysteine had no significant effect on growth hormone and IGF1 levels but caused a significant decrease in plasma TNF-alpha |
Mirtazapine | Antidepressant | II and III | NCT03254173 | Egypt | Completed | Not available |
| Â | Â | III | NCT03283488 | Brazil | Recruiting | On intention-to-treat analysis at week 4, 4 of 17 patients gained 1Â kg or more, 1 patient maintained weight (gain of 400Â g) and 2 patients lost weight (800Â g and 1.2Â kg). 24% and 6% of the patients improved appetite and health-related quality of life, respectively |
Remune | Nutritional supplement | I | NCT04131426 | USA | Recruiting | Not available |
Pancrelipase | Appetite stimulant | II | NCT04098237 | USA | Recruiting | Not available |
Olanzapine | Antipsychotic, neurotransmitter | III | NCT05243251 | Egypt | Recruiting | Not available |