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Randomised phase III clinical trial of 5 different arms of treatment on 332 patients with cancer cachexia.
Eur Rev Med Pharmacol Sci. 2010 Apr; 14(4):292-301.ER

Abstract

BACKGROUND AND OBJECTIVE

A phase III randomised study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia: lean body mass (LBM), resting energy expenditure (REE), fatigue; and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines.

PATIENTS

Three hundred and thirty-two assessable patients with cancer-related anorexia/cachexia syndrome (CACS) were randomly assigned to one of five arms of treatment: 1--medroxyprogesterone 500 mg/d or megestrol acetate 320 mg/d; 2--oral supplementation with eicosapentaenoic acid (EPA); 3--L-carnitine 4 g/d; 4--thalidomide 200 mg/d; 5--a combination of the above. Treatment duration: 4 months.

RESULTS

Analysis of variance showed a significant difference between the treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5. IL-6 decreased significantly in arm 5 and 4. GPS significantly decreased in arms 5, 4 and 3. Total daily physical activity showed that total energy and active energy expenditure increased significantly in arm 5. Eastern Cooperative Oncology group-Performance Status (ECOG-PS) significantly decreased in arms 5, 4 and 3. Toxicity was substantially negligible, comparable between treatment arms.

CONCLUSIONS

The most effective treatment for all three primary efficacy endpoints as well as secondary endpoints appetite, IL-6, GPS and ECOG PS was the combination regimen that included all selected agents.

Authors+Show Affiliations

Department of Medical Oncology, Schoool of Medicine, University of Cagliari, Italy. mantovan@medicina.unica.it

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

20496538

Citation

Mantovani, G. "Randomised Phase III Clinical Trial of 5 Different Arms of Treatment On 332 Patients With Cancer Cachexia." European Review for Medical and Pharmacological Sciences, vol. 14, no. 4, 2010, pp. 292-301.
Mantovani G. Randomised phase III clinical trial of 5 different arms of treatment on 332 patients with cancer cachexia. Eur Rev Med Pharmacol Sci. 2010;14(4):292-301.
Mantovani, G. (2010). Randomised phase III clinical trial of 5 different arms of treatment on 332 patients with cancer cachexia. European Review for Medical and Pharmacological Sciences, 14(4), 292-301.
Mantovani G. Randomised Phase III Clinical Trial of 5 Different Arms of Treatment On 332 Patients With Cancer Cachexia. Eur Rev Med Pharmacol Sci. 2010;14(4):292-301. PubMed PMID: 20496538.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised phase III clinical trial of 5 different arms of treatment on 332 patients with cancer cachexia. A1 - Mantovani,G, PY - 2010/5/26/entrez PY - 2010/5/26/pubmed PY - 2010/6/12/medline SP - 292 EP - 301 JF - European review for medical and pharmacological sciences JO - Eur Rev Med Pharmacol Sci VL - 14 IS - 4 N2 - BACKGROUND AND OBJECTIVE: A phase III randomised study was carried out to establish the most effective and safest treatment to improve the primary endpoints of cancer cachexia: lean body mass (LBM), resting energy expenditure (REE), fatigue; and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines. PATIENTS: Three hundred and thirty-two assessable patients with cancer-related anorexia/cachexia syndrome (CACS) were randomly assigned to one of five arms of treatment: 1--medroxyprogesterone 500 mg/d or megestrol acetate 320 mg/d; 2--oral supplementation with eicosapentaenoic acid (EPA); 3--L-carnitine 4 g/d; 4--thalidomide 200 mg/d; 5--a combination of the above. Treatment duration: 4 months. RESULTS: Analysis of variance showed a significant difference between the treatment arms. A post hoc analysis showed the superiority of arm 5 over the others for all primary endpoints. An analysis of changes from baseline showed that LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) significantly increased in arm 5. REE decreased significantly and fatigue improved significantly in arm 5. Appetite increased significantly in arm 5. IL-6 decreased significantly in arm 5 and 4. GPS significantly decreased in arms 5, 4 and 3. Total daily physical activity showed that total energy and active energy expenditure increased significantly in arm 5. Eastern Cooperative Oncology group-Performance Status (ECOG-PS) significantly decreased in arms 5, 4 and 3. Toxicity was substantially negligible, comparable between treatment arms. CONCLUSIONS: The most effective treatment for all three primary efficacy endpoints as well as secondary endpoints appetite, IL-6, GPS and ECOG PS was the combination regimen that included all selected agents. SN - 1128-3602 UR - https://www.unboundmedicine.com/medline/citation/20496538/Randomised_phase_III_clinical_trial_of_5_different_arms_of_treatment_on_332_patients_with_cancer_cachexia_ DB - PRIME DP - Unbound Medicine ER -