Table 3 Clinical trials of anticachexia treatment
From: Cancer cachexia: molecular basis and therapeutic advances
Compound/drug | Target/agent | Study | Phase | Status | Cancer Type | Treatment outcomes | References |
|---|---|---|---|---|---|---|---|
Anamorelin | Ghrelin receptor agonist | NCT00267358 | II | Completed | BRCA,CRC,LC,PC,RCC and other | Increased LBM | |
NCT00219817 | II | Completed | |||||
NCT01387282 NCT01387269 | III | Completed | NSCLC | Increased LBM, but not handgrip, strength | |||
NCT01395914 | III | Completed | NSCLC | Improved BW and symptom burden | |||
JapicCTI-142451 | II | Completed | NSCLC | Increased LBM; improved anorexia symptoms and the nutritional state | |||
JapicCTI-111415 | II | Completed | NSCLC | Increased LBM; improved QoL | |||
JapicCTI-163426 | - | Completed | GI cancer | Increased LBM and BW | |||
Garcia JM et al. | - | Completed | BRCA,CRC,LC,NHL,PC and other | Increased BW and food intake; improved appetite | |||
NCT03743064 | III | Completed | NSCLC | Increased BW | NA | ||
NCT03743051 | III | Completed | NSCLC | Increased BW | NA | ||
NCT03637816 | II&III | Active, not recruiting | NSCLC | NA | NA | ||
NCT04844970 | II | Recruiting | PDAC | NA | NA | ||
NCT01505764 | II | Terminated | NSCLC,CRC | Terminated due to poor recruitment | NA | ||
Macimorelin | Ghrelin receptor agonist | NCT01614990 | II | Completed | GI cancer,LC,NE, Hematologic cancer | Improved BW and QoL | |
Ponsegromab | GDF15 | NCT05546476 | II | Active, not recruiting | NSCLC,PDAC,CRC | Increased BW and overall activity level; reduced cachexia symptoms | |
NCT04299048 | Ib | Active, not recruiting | NSCLC,PDAC,CRC | Improved BW, appetite, and physical activity; suppressed serum GDF15 levels | |||
NCT04803305 | I | Completed | NSCLC,PDAC,CRC,PC,BRCA,OC | NA | NA | ||
AV-380 | GDF15 | NCT05865535 | I | Recruiting | CRC,PDAC | NA | NA |
LY2495655 | Myostatin | NCT01505530 | II | Completed | PDAC | No clinical benefit | |
Enobosarm/Gtx-024 | Androgen Receptor | NCT00467844 | II | Completed | NSCLC, CRC and other | Improved LBM | |
NCT01355497 NCT01355484 | III | Completed | NSCLC | NA | |||
Testosterone | Androgen Receptor | NCT00878995 | I | Completed | HNSCC,CC | Improved LBM, QoL and physical activity | |
APD209 | Androgenmetabolism | NCT00895726 | II | Completed | NA | NA | NA |
Espindolol/MT-102 | ß-adrenergic | NCT01238107 | II | Completed | NSCLC,CRC | Reversed weight loss; improved fat free mass; maintained fat mass | |
VT-122 | ß-adrenergic | NCT00527319 | II | Completed | NSCLC | NA | NA |
NCT01265576 | II | Unknown | HCC | NA | NA | ||
Xilonix/MABp1 | IL-1α | NCT02138422 | III | Completed | CRC | A significant reduction in systemic inflammation and thrombocytosis | |
ALD518 | IL-6 | NCT00866970 | II | Completed | NSCLC | NA | NA |
Selumetinib | MEK | Prado CM et al. | II | Completed | BTC | Promoted muscle gain | |
Bekaii-Saab T | II | Completed | BTC | Gained nonfluid weight | |||
Binimetinib | MEK | NCT00959127 | I | Completed | BTC | Increased nonfluid weight | |
Etanercept | TNF-α | NCT00046904 | III | Completed | GI cancer,LC and other | Etanercept does not appear to palliate the cancer anorexia/weight loss syndrome | |
Infliximab | TNF-α | NCT00040885 | III | Completed | NSCLC | Early evidence of the lack of efficacy promoted early trial closure | |
NCT00060502 | II | Completed | PDAC | No statistically significant differences in LBM | |||
Curcumin | NF-кB | NCT04208334 | II | Completed | HNSCC | Increased muscle mass | |
TCTR20220521003 | IIa | Completed | LC,HNC,GC,CRC,BRCA and other | Slow progression of hand-grip muscle strength loss, and basal metabolic rate; increased the body composition(not statistically significant) | |||
Ruxolitinib | JAK/STAT | NCT04906746 | I | Recruiting | NSCLC | NA | NA |
NCT02072057 | II | Terminated | Any type | Terminated due to poor recruitment | NA | ||
Ketorolac | NSAIDs | NCT05336266 | I | Active, not recruiting | PDAC | NA | NA |
Celecoxib | NSAIDs | Lai V et al. | II | Completed | HNC,GI cancer | Increased BW and BMI; improved QoL | |
Mantovani G et al. | II | Completed | HNC,LC,CRC,OC,GC,BRCA | Increased LBM; improved grip strength, QoL, performance status; decreased of TNF-alpha | |||
IRCT201407222027N4 | III | Completed | GI cancer | Adding celecoxib to megestrol could not enhance anti-cachexic effects of megestrol | |||
Lenalidomide | Immunomodulatory agent | NCT01127386 | I/II | Completed | Any type | NA | NA |
Thalidomide | Immunomodulatory agent | Gordon JN et al. | - | Completed | PDAC | Increased weight and arm muscle mass; improved physical function | |
Davis M et al. | II | Completed | LC,BRCA,HNC,GI cancer, and other | Improved appetite and QoL | |||
Yennurajalingam S et al. | - | Completed | HNC,BRCA,MM,GI and Genitourinary cancer | Both the thalidomide and the placebo groups showed significant reduction in cytokines, improvement were not significantly different in two group | |||
Wen HS et al. | - | Completed | LC,BRCA,HPB,GI cancer, | A combination regimen of Megestrol acetate and thalidomide is more effective than Megestrol acetate alone | |||
OHR/AVR118 | Immunomodulatory agent | NCT01206335 | II | Unkown | PDAC,LC,CRC,GC,HNSCC,PC | Weight stabilization or gain; improvements in anorexia, dyspepsia, strength, and depression | |
N-acetylcysteine | Antioxidant | NCT00196885 | II | Completed | GI cancer,LC | Increased knee extensor strength and the sum of all strength paramete; decreased plasma TNF-alpha | NA |
L-CARnitine | Antioxidant | NCT01330823/ISRCTN83465351 | III | Suspended | PDAC | Increased BMI; improved nutritional status (body cell mass, body fat) and QoL; increased overall survival | |
Insulatard | Insulin | NCT00329615 | IV | Completed | BTC,PDAC,GI cancer, and other | NA | NA |
Insulin | Insulin | Lundholm K et al. | - | Completed | GI cancer,HPB | Increased carbohydrate intake; increased whole body fat; improved metabolic efficiency during exercise; decreased serum-free fatty acids, | |
Pioglitazone | Insulin sensitizer | NCT05919147 | II | Recruiting | NSCLC,GI cancer | NA | NA |
Nandrolone | Corticosteroid | NCT03263520 | - | Completed | GI cancer,HPB | NA | NA |
Melatonin | Pleiotropic hormone | NCT00513357 | III | Completed | LC,GI cancer | Oral melatonin 20 mg at night did not improve appetite, weight, or QoL compared with placebo | |
Adenosine Triphosphate | ATP | Beijer S et al. | - | Completed | LC,HNC,PDAC,HL,PC,CC,HCC,GI cancer and other | Increased triceps skin fold thicknes; improved survival | |
NCT00014248 | I | Completed | Any type | NA | NA | ||
Olanzapine | Antipsychotic, Appetite stimulant | Sandhya L et al. | - | Completed | GC,HPB,LC | Improved appetite; increased weight | |
NCT05243251 | III | Completed | Any type | NA | NA | ||
NCT00489593 | I | Completed | Any type | NA | NA | ||
NCT06517199 | III | Recruiting | Any type | NA | NA | ||
NCT05705492 | II | Recruiting | ESCC,GC,HPB,LC | NA | NA | ||
Mirtazapine | Antidepressant, Appetite stimulant | Riechelmann RP et al. | II | Completed | GI cancer, BRCA, LC and other | Increased BW; improved appetite and health-related QoL | |
NCT03283488 | II | Completed | PC,LC,HNC,GI cancer and other | Weight gain and appetite improved | |||
NCT04748523 | - | Completed | NSCLC | Increased energy intake(mainly in fat intake); achieved energy requirements; improved QoL | |||
NCT03254173 | II&III | Completed | Any type | NA | NA | ||
NCT05380479 | II | Unkown | Any type | NA | NA | ||
NCT01501396 | II | Withdrawn | Any type | NA | NA | ||
Megestrol acetate | Appetite stimulant | NCT00006799 | III | Completed | HNC and LC | Maintained BW; improved QoL | |
NCT00439101 | - | Completed | AML,ALL,HL,NHL OS,ES (Children) | Increased weight | |||
IRCT201407222027N4 | III | Completed | GI cancer | Increased BW; improved grip strength, appetite score and QoL | |||
NCT00031785 | III | Completed | LC | NA | NA | ||
NCT00004912 | II | Completed | Any type | NA | NA | ||
Nanocrystalline megestrol acetate | Appetite stimulant | NCT06793228 | II | Not yet recruiting | SCLC | NA | NA |
Ghrelin | Appetite stimulant | NCT00933361 | I&II | Completed | PDAC,MESO,PC, NSCLC,CCA, GI and Urogenital cancer | No grade 3/4 toxicity or stimulation of tumor growth, Ghrelin is well tolerated and safe | |
Cyproheptadine | Appetite stimulant | NCT00066248 | II | Completed | Children cancers | Cyproheptadine is a safe and effective way to promote weight gain | |
NCT01132547 | III | Terminated | Children cancers | Terminated due to slow accrual | NA | ||
NCT05856500 | - | Not yet recruiting | GI cancer | NA | NA | ||
Pancrelipase | Appetite stimulant | NCT04098237 | II | Recruiting | PDAC | NA | NA |
Nabilone | Cannabis | NCT02802540 | II&III | Unknown status | LC | Increased caloric intake; improved QoL | |
Cannabis | Cannabis | NCT02359123 | - | Completed | LC,PDAC,PC,GC,MM,HNSCC,Sarcoma | Increased BW without significant side effects | |
Cannabidiol | Cannabis | NCT04585841 | I | Completed | Any type | NA | NA |
PPP011/CAUM | Cannabis | NCT04001010 | III | Suspended | Any type | NA | NA |
Omega-3 fatty acids | Nutritional supplement | NCT00003077 | I&II | Completed | Any type | A majority of patients did not gain weight, but a small but definite subset of patients had weight stabilization or weight gain | |
KA080091 | - | Completed | HNSCC | Improved BW and serum albumin and prealbumin levels | |||
NCT01596933 | II&III | Completed | HNSCC | Failed to protect against weight loss, or improve nutritional parameters | |||
Abe K et al. | - | Completed | PDAC, BTC | Increased skeletal muscle mass, NK cell activity, and absorption of omega-3 fatty acids | |||
Werner K et al. | - | Completed | PDAC | Weight and appetite stabilization and improved QoL | |||
Creatine | Nutritional supplement | NCT00081250 | III | Completed | LC,GI cancer and other | Creatine, as prescribed in this trial, had no effect on the cancer anorexia/weight loss syndrome | |
Remune | Nutritional supplement | NCT04131426 | I | Completed | PDAC,BTC,NSCLC,GI cancer | NA | NA |
Oligo-Fucoidan | Nutritional supplement | NCT05623852 | II | Recruiting | NSCLC,CRC,HNC, PDAC | NA | NA |
Kanglaite | Nutritional supplement | NCT03631459 | - | Unknown | LC,HCC,PDAC,GC | NA | NA |
NCT02553187 | IV | Unknown | NSCLC,CRC,PDAC | NA | NA | ||
IMN1207 | Nutritional supplement | NCT01046383 | III | Terminated | NSCLC | Terminated due to slow recruitment | NA |
Sipjeondaebo-Tang | Kampo medicine | NCT02468141 | - | Completed | BRCA,CC,CRC,GC,LC,TC | Sipjeondaebo-tang did not show a significant effect on anorexia | |
Fecal Microbiota Transplantation(FMT) | Microbiota | de Clercq NC et al. | II | Completed | ESCC,GC | Allogenic FMT did not improve any of the cachexia outcomes but improved response and survival | |
SXRN | SXRN Plasmid DNA Technique | NCT06736275 | I | Recruiting | Any type | NA | NA |
