Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&N Cancer Who Receiving CCRT
16 janvier 2017 mis à jour par: TTY Biopharm
A Phase II Study Assessing the Efficacy of Prophylaxis Use of Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With Head and Neck Cancer Who Receiving Concurrent Chemoradiotherapy
Primary Objective:
To evaluate the population prevalence of critical body weight loss ( more than 5% from baseline) in patients with Head and Neck cancer.
Secondary Objectives:
To evaluate the impact of appetite, and performance status; To evaluate the change of quality of life (QoL); To evaluate the incidence of infection and hospitalization; To evaluate the safety profiles
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Description détaillée
Hypothesis testing will be used to determine the patient number in this study.
According to a preliminary data at CGMH-LK, the investigators have the untreated patients with population prevalence of critical weight loss that is 0.56, and the investigators assume the study treated population prevalence is 0.4, power set in 0.9, alpha set in 0.05.
Type d'étude
Interventionnel
Inscription (Anticipé)
105
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Linkou, Taïwan
- Recrutement
- Chang-Gung Memorial Hospital, Linkou
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Patient who is confirmed the diagnosis of head and neck cancer and will receive concurrent chemoradiotherapy (CCRT).
- Patient who is capable to understand and complete questionnaires
- Patient who is convenient to receive body weight measurement
- Life expectancy of at least 12 weeks
- Age over 20 years old at registration
- Voluntarily signed the written informed consent form
Exclusion Criteria:
- Special populations that needs unique risk/benefit considerations. (Ex. Pregnant or nursing women or mental disorder patients, et al.)
- Any significant co-morbid medical condition that out of medication control. (Ex. Heart/renal/hepatic failure or poorly controlled diabetes, et al.)
- Any evidence of mechanical obstruction of the alimentary track, malabsorption, or intractable vomiting.
- Any thromboembolism event, e.g. cerebral or peripheral vascular disease
- Judged ineligible by physicians for participation in the study due to any safety concern.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Megestrol
Single arm
|
Megestrol acetate (MA) will be given on 400 mg/day as eligible patient begin CCRT.
Total treatment period is for a maximum of 12 weeks calculated from the date of first dose.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Critical body weight loss
Délai: 12 weeks
|
To evaluate the population prevalence of critical body weight loss ( > 5% from baseline) in patients with Head and Neck cancer
|
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Impact of appetite
Délai: 12 weeks
|
The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study.
The assessment of appetite will be performed by the visual analogue scale(VAS) within the range of 0-100mm(please refer Appendix II).
The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation.
|
12 weeks
|
|
Impact of performance status
Délai: 12 weeks
|
The assessment of appetite will be performed before the entry of the study, and then repeated every visit until end of study.
The measurement will base on ECOG performance status scale(please refer Appendix I).
The Differences from baseline status will be assessed, and results will be presented in percentages of improved patients out of those treated at the time of evaluation.
|
12 weeks
|
|
Change of quality of life (QoL)
Délai: 12 weeks
|
Quality of life (QOL) will be evaluated since patient registration to off study by means of the Functional Assessment of Cancer Therapy-Head and Neck (FACT-.
H&N), Version 4 (Traditional Chinese) (please refer Appendix III).
The questionnaire will be completed under the assistance of a trained study nurse.
|
12 weeks
|
|
Incidence of infection and hospitalization
Délai: 12 weeks
|
If any patient in the study period (3 months) suffer infection or hospitalization, that should be recorded on Case Report Form for the descriptive statistics analysis.
|
12 weeks
|
|
Safety profiles (percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade)
Délai: 12 weeks
|
Adverse event / toxicity assessment are based on NCI- Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03), please refer Appendix IV), and will be evaluated before the treatment, and then repeated each visit until off study.
The incidence and percentage of patients with at least one occurrence of preferred term will be included, according to the most severe NCI-CTCAE v4.03 grade.
|
12 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measurability of Anthropometric Evaluation
Délai: 12 weeks
|
Anthropometric evaluation is including body weight and body mass index.
|
12 weeks
|
|
Lab test
Délai: 12 weeks
|
Lab test should be conducted every patient's visit for safety assessment.
CRP and TNFα will be exanimated at screening and every 4 weeks of the treatment period.
|
12 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hung-Ming Wang, M.D., Chang Gung Memorial Hospital, Linkou, Taiwan
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Donohoe CL, Ryan AM, Reynolds JV. Cancer cachexia: mechanisms and clinical implications. Gastroenterol Res Pract. 2011;2011:601434. doi: 10.1155/2011/601434. Epub 2011 Jun 13.
- Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
- Rogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084.
- Tomiska M, Tomiskova M, Salajka F, Adam Z, Vorlicek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33.
- Kumar NB, Kazi A, Smith T, Crocker T, Yu D, Reich RR, Reddy K, Hastings S, Exterman M, Balducci L, Dalton K, Bepler G. Cancer cachexia: traditional therapies and novel molecular mechanism-based approaches to treatment. Curr Treat Options Oncol. 2010 Dec;11(3-4):107-17. doi: 10.1007/s11864-010-0127-z.
- Vadell C, Segui MA, Gimenez-Arnau JM, Morales S, Cirera L, Bestit I, Batiste E, Blanco R, Jolis L, Boleda M, Anton I. Anticachectic efficacy of megestrol acetate at different doses and versus placebo in patients with neoplastic cachexia. Am J Clin Oncol. 1998 Aug;21(4):347-51. doi: 10.1097/00000421-199808000-00006.
- Pascual Lopez A, Roque i Figuls M, Urrutia Cuchi G, Berenstein EG, Almenar Pasies B, Balcells Alegre M, Herdman M. Systematic review of megestrol acetate in the treatment of anorexia-cachexia syndrome. J Pain Symptom Manage. 2004 Apr;27(4):360-9. doi: 10.1016/j.jpainsymman.2003.09.007.
- Inui A. Cancer anorexia-cachexia syndrome: current issues in research and management. CA Cancer J Clin. 2002 Mar-Apr;52(2):72-91. doi: 10.3322/canjclin.52.2.72.
- Maltoni M, Nanni O, Scarpi E, Rossi D, Serra P, Amadori D. High-dose progestins for the treatment of cancer anorexia-cachexia syndrome: a systematic review of randomised clinical trials. Ann Oncol. 2001 Mar;12(3):289-300. doi: 10.1023/a:1011156811739.
- Beller E, Tattersall M, Lumley T, Levi J, Dalley D, Olver I, Page J, Abdi E, Wynne C, Friedlander M, Boadle D, Wheeler H, Margrie S, Simes RJ. Improved quality of life with megestrol acetate in patients with endocrine-insensitive advanced cancer: a randomised placebo-controlled trial. Australasian Megestrol Acetate Cooperative Study Group. Ann Oncol. 1997 Mar;8(3):277-83. doi: 10.1023/a:1008291825695.
- De Conno F, Martini C, Zecca E, Balzarini A, Venturino P, Groff L, Caraceni A. Megestrol acetate for anorexia in patients with far-advanced cancer: a double-blind controlled clinical trial. Eur J Cancer. 1998 Oct;34(11):1705-9. doi: 10.1016/s0959-8049(98)00219-6.
- Gebbia V, Testa A, Gebbia N. Prospective randomised trial of two dose levels of megestrol acetate in the management of anorexia-cachexia syndrome in patients with metastatic cancer. Br J Cancer. 1996 Jun;73(12):1576-80. doi: 10.1038/bjc.1996.297.
- Loprinzi CL, Michalak JC, Schaid DJ, Mailliard JA, Athmann LM, Goldberg RM, Tschetter LK, Hatfield AK, Morton RF. Phase III evaluation of four doses of megestrol acetate as therapy for patients with cancer anorexia and/or cachexia. J Clin Oncol. 1993 Apr;11(4):762-7. doi: 10.1200/JCO.1993.11.4.762.
- Tchekmedyian NS, Hickman M, Siau J, Greco FA, Keller J, Browder H, Aisner J. Megestrol acetate in cancer anorexia and weight loss. Cancer. 1992 Mar 1;69(5):1268-74. doi: 10.1002/cncr.2820690532.
- McRackan TR, Watkins JM, Herrin AE, Garrett-Mayer EM, Sharma AK, Day TA, Gillespie MB. Effect of body mass index on chemoradiation outcomes in head and neck cancer. Laryngoscope. 2008 Jul;118(7):1180-5. doi: 10.1097/MLG.0b013e31816fca5c.
- Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25.
- Capuano G, Grosso A, Gentile PC, Battista M, Bianciardi F, Di Palma A, Pavese I, Satta F, Tosti M, Palladino A, Coiro G, Di Palma M. Influence of weight loss on outcomes in patients with head and neck cancer undergoing concomitant chemoradiotherapy. Head Neck. 2008 Apr;30(4):503-8. doi: 10.1002/hed.20737.
- Mantovani G, Maccio A, Bianchi A, Curreli L, Ghiani M, Santona MC, Del Giacco GS. Megestrol acetate in neoplastic anorexia/cachexia: clinical evaluation and comparison with cytokine levels in patients with head and neck carcinoma treated with neoadjuvant chemotherapy. Int J Clin Lab Res. 1995;25(3):135-41. doi: 10.1007/BF02592554.
- Capozzi LC, Lau H, Reimer RA, McNeely M, Giese-Davis J, Culos-Reed SN. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial. BMC Cancer. 2012 Oct 2;12:446. doi: 10.1186/1471-2407-12-446.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2015
Achèvement primaire (Anticipé)
1 août 2017
Achèvement de l'étude (Anticipé)
1 décembre 2017
Dates d'inscription aux études
Première soumission
25 juillet 2016
Première soumission répondant aux critères de contrôle qualité
29 novembre 2016
Première publication (Estimation)
2 décembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
18 janvier 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 janvier 2017
Dernière vérification
1 janvier 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs par site
- Changements de poids corporel
- Tumeurs de la tête et du cou
- Perte de poids
- Poids
- Effets physiologiques des médicaments
- Agents antinéoplasiques
- Agents antinéoplasiques, hormonaux
- Agents contraceptifs, hormonaux
- Agents contraceptifs
- Agents de contrôle de la reproduction
- Contraceptifs oraux
- Agents contraceptifs, femmes
- Contraceptifs, Oraux, Synthétiques
- Contraceptifs, oraux, hormonaux
- Stimulants du système nerveux central
- Stimulants de l'appétit
- Mégestrol
- Acétate de mégestrol
Autres numéros d'identification d'étude
- TTYMG1403
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .