Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&N Cancer Who Receiving CCRT

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02980653
• Other study ID #: TTYMG1403
• Status: Recruiting
• Phase: Phase 2
• First received: July 25, 2016
• Last updated: January 16, 2017
• Start date: May 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: TTY Biopharm
• Contact: Hung-Ming Wang, M.D.
• Phone: +886 3 3281200
• Email: whm526[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Head and Neck Cancer
• Head and Neck Neoplasms
• Weight Loss

Intervention

Drug:
• Megestrol acetate (MA) 400 mg/day
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.

Locations

Country	Name	City	State
Taiwan	Chang-Gung Memorial Hospital, Linkou	Linkou

Sponsors (2)

Lead Sponsor	Collaborator
TTY Biopharm	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Donohoe CL, Ryan AM, Reynolds JV. Cancer cachexia: mechanisms and clinical implications. Gastroenterol Res Pract. 2011;2011:601434. doi: 10.1155/2011/601434. — View Citation

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. Review. — View Citation

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. — View Citation

Inui A. Cancer anorexia-cachexia syndrome: current issues in research and management. CA Cancer J Clin. 2002 Mar-Apr;52(2):72-91. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Mantovani G, Macciò 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. — View Citation

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. — View Citation

Pascual López A, Roqué i Figuls M, Urrútia 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. Review. — View Citation

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. — View Citation

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. — View Citation

Tomíska M, Tomisková M, Salajka F, Adam Z, Vorlícek J. Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Neoplasma. 2003;50(3):227-33. — View Citation

Vadell C, Seguí MA, Giménez-Arnau JM, Morales S, Cirera L, Bestit I, Batiste E, Blanco R, Jolis L, Boleda M, Antón 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurability of Anthropometric Evaluation	Anthropometric evaluation is including body weight and body mass index.	12 weeks
Other	Lab test	Lab test should be conducted every patient's visit for safety assessment. CRP and TNFa will be exanimated at screening and every 4 weeks of the treatment period.	12 weeks
Primary	Critical body weight loss	To evaluate the population prevalence of critical body weight loss ( > 5% from baseline) in patients with Head and Neck cancer	12 weeks
Secondary	Impact of appetite	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
Secondary	Impact of performance status	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
Secondary	Change of quality of life (QoL)	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
Secondary	Incidence of infection and hospitalization	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
Secondary	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)	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