title: Randomized phase III clinical trial of a combined treatment with carnitine + celecoxib ± megestrol acetate for patients with cancer-related anorexia/cachexia syndrome.
abstract: OBJECTIVE
  A phase III, randomized non-inferiority study was carried out to compare a two-drug combination (including nutraceuticals, i.e. antioxidants) with carnitine + celecoxib ± megestrol acetate for the treatment of cancer-related anorexia/cachexia syndrome (CACS): the primary endpoints were increase of lean body mass (LBM) and improvement of total daily physical activity. Secondary endpoint was: increase of physical performance tested by grip strength and 6-min walk test.
  
  
  METHODS
  Sixty eligible patients were randomly assigned to: arm 1, L-carnitine 4 g/day + Celecoxib 300 mg/day or arm 2, L-carnitine 4 g/day + celecoxib 300 mg/day + megestrol acetate 320 mg/day, all orally. All patients received as basic treatment polyphenols 300 mg/day, lipoic acid 300 mg/day, carbocysteine 2.7 g/day, Vitamin E, A, C. Treatment duration was 4 months. Planned sample size was 60 patients.
  
  
  RESULTS
  The results did not show a significant difference between tre atment arms in both primary and secondary endpoints. Analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) increased significantly in both arms as well as physical performance assessed by 6MWT. Toxicity was quite negligible and comparable between arms.
  
  
  CONCLUSIONS
  The results of the present study showed a non-inferiority of arm 1 (two-drug combination) vs arm 2 (two-drug combination + megestrol acetate). Therefore, this simple, feasible, effective, safe, low cost with favorable cost-benefit profile, two-drug approach could be suggested in the clinical practice to implement CACS treatment.
authors: Department of Medical Oncology, University of Cagliari, Cagliari, Italy.
authors: Clelia
authors: C
authors: Madeddu
authors: Mariele
authors: M
authors: Dessì
authors: Filomena
authors: F
authors: Panzone
authors: Roberto
authors: R
authors: Serpe
authors: Giorgia
authors: G
authors: Antoni
authors: Maria Chiara
authors: MC
authors: Cau
authors: Lorenza
authors: L
authors: Montaldo
authors: Quirico
authors: Q
authors: Mela
authors: Marco
authors: M
authors: Mura
authors: Giorgio
authors: G
authors: Astara
authors: Francesca Maria
authors: FM
authors: Tanca
authors: Antonio
authors: A
authors: Macciò
authors: Giovanni
authors: G
authors: Mantovani
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000150:complications / Q000188:drug therapy*; D001066:Appetite; D002100:Cachexia / Q000150:complications / Q000188:drug therapy*; D002331:Carnitine / Q000627:therapeutic use*; D000068579:Celecoxib; D003131:Combined Modality Therapy; D004338:Drug Combinations; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D008297:Male; D019290:Megestrol Acetate / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D010349:Patient Compliance; D011720:Pyrazoles / Q000627:therapeutic use*; D011788:Quality of Life; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D002331:Carnitine; D019290:Megestrol Acetate