Tags

Type your tag names separated by a space and hit enter

Randomized phase III clinical trial of five different arms of treatment in 332 patients with cancer cachexia.
Oncologist. 2010; 15(2):200-11.O

Abstract

PURPOSE

A phase III, randomized 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), and fatigue-and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines.

PATIENTS AND METHODS

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

RESULTS

Analysis of variance showed a significant difference between 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; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms.

CONCLUSION

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

Authors+Show Affiliations

Department of Medical Oncology,University of Cagliari, Cagliari, Italy. mantovan@medicina.unica.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

20156909

Citation

Mantovani, Giovanni, et al. "Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients With Cancer Cachexia." The Oncologist, vol. 15, no. 2, 2010, pp. 200-11.
Mantovani G, Macciò A, Madeddu C, et al. Randomized phase III clinical trial of five different arms of treatment in 332 patients with cancer cachexia. Oncologist. 2010;15(2):200-11.
Mantovani, G., Macciò, A., Madeddu, C., Serpe, R., Massa, E., Dessì, M., Panzone, F., & Contu, P. (2010). Randomized phase III clinical trial of five different arms of treatment in 332 patients with cancer cachexia. The Oncologist, 15(2), 200-11. https://doi.org/10.1634/theoncologist.2009-0153
Mantovani G, et al. Randomized Phase III Clinical Trial of Five Different Arms of Treatment in 332 Patients With Cancer Cachexia. Oncologist. 2010;15(2):200-11. PubMed PMID: 20156909.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized phase III clinical trial of five different arms of treatment in 332 patients with cancer cachexia. AU - Mantovani,Giovanni, AU - Macciò,Antonio, AU - Madeddu,Clelia, AU - Serpe,Roberto, AU - Massa,Elena, AU - Dessì,Mariele, AU - Panzone,Filomena, AU - Contu,Paolo, Y1 - 2010/02/15/ PY - 2010/2/17/entrez PY - 2010/2/17/pubmed PY - 2010/6/11/medline SP - 200 EP - 11 JF - The oncologist JO - Oncologist VL - 15 IS - 2 N2 - PURPOSE: A phase III, randomized 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), and fatigue-and relevant secondary endpoints: appetite, quality of life, grip strength, Glasgow Prognostic Score (GPS) and proinflammatory cytokines. PATIENTS AND METHODS: Three hundred thirty-two assessable patients with cancer-related anorexia/cachexia syndrome were randomly assigned to one of five treatment arms: arm 1, medroxyprogesterone (500 mg/day) or megestrol acetate (320 mg/day); arm 2, oral supplementation with eicosapentaenoic acid; arm 3, L-carnitine (4 g/day); arm 4, thalidomide (200 mg/day); and arm 5, a combination of the above. Treatment duration was 4 months. RESULTS: Analysis of variance showed a significant difference between 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; interleukin (IL)-6 decreased significantly in arm 5 and arm 4; GPS and Eastern Cooperative Oncology Group performance status (ECOG PS) score decreased significantly in arm 5, arm 4, and arm 3. Toxicity was quite negligible, and was comparable between arms. CONCLUSION: The most effective treatment in terms of all three primary efficacy endpoints and the secondary endpoints appetite, IL-6, GPS, and ECOG PS score was the combination regimen that included all selected agents. SN - 1549-490X UR - https://www.unboundmedicine.com/medline/citation/20156909/Randomized_phase_III_clinical_trial_of_five_different_arms_of_treatment_in_332_patients_with_cancer_cachexia_ L2 - https://doi.org/10.1634/theoncologist.2009-0153 DB - PRIME DP - Unbound Medicine ER -