دورية أكاديمية
Randomized phase III clinical trial of a combined treatment with carnitine + celecoxib ± megestrol acetate for patients with cancer-related anorexia/cachexia syndrome.
| العنوان: | Randomized phase III clinical trial of a combined treatment with carnitine + celecoxib ± megestrol acetate for patients with cancer-related anorexia/cachexia syndrome. |
|---|---|
| المؤلفون: | Madeddu C; Department of Medical Oncology, University of Cagliari, Cagliari, Italy., Dessì M, Panzone F, Serpe R, Antoni G, Cau MC, Montaldo L, Mela Q, Mura M, Astara G, Tanca FM, Macciò A, Mantovani G |
| المصدر: | Clinical nutrition (Edinburgh, Scotland) [Clin Nutr] 2012 Apr; Vol. 31 (2), pp. 176-82. Date of Electronic Publication: 2011 Nov 01. |
| نوع المنشور: | Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 8309603 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-1983 (Electronic) Linking ISSN: 02615614 NLM ISO Abbreviation: Clin Nutr Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2004->: Kidlington, Oxford, U.K. : Elsevier Original Publication: Edinburgh ; New York : Churchill Livingstone, c1982- |
| مواضيع طبية MeSH: | Anorexia/*drug therapy , Cachexia/*drug therapy , Carnitine/*therapeutic use , Megestrol Acetate/*therapeutic use , Neoplasms/*complications , Pyrazoles/*therapeutic use , Sulfonamides/*therapeutic use, Absorptiometry, Photon ; Aged ; Aged, 80 and over ; Anorexia/complications ; Appetite ; Cachexia/complications ; Celecoxib ; Combined Modality Therapy ; Drug Combinations ; Endpoint Determination ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/drug therapy ; Patient Compliance ; Quality of Life ; Treatment Outcome |
| مستخلص: | Background & Aims: 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. (Copyright © 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.) |
| المشرفين على المادة: | 0 (Drug Combinations) 0 (Pyrazoles) 0 (Sulfonamides) JCX84Q7J1L (Celecoxib) S7UI8SM58A (Carnitine) TJ2M0FR8ES (Megestrol Acetate) |
| تواريخ الأحداث: | Date Created: 20111104 Date Completed: 20120723 Latest Revision: 20151119 |
| رمز التحديث: | 20221213 |
| DOI: | 10.1016/j.clnu.2011.10.005 |
| PMID: | 22047681 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1532-1983 |
|---|---|
| DOI: | 10.1016/j.clnu.2011.10.005 |