Back to resultsMegestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&N Cancer Who Receiving CCRT
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Megestrol acetate (MA) 400 mg/day
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Phase II study, Critical body weight loss, Concurrent chemoradiotherapy, Megestrol acetate, Head and neck cancer
Eligibility Criteria
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.
Sites / Locations
- Chang-Gung Memorial Hospital, LinkouRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Megestrol
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Critical body weight loss
To evaluate the population prevalence of critical body weight loss ( > 5% from baseline) in patients with Head and Neck cancer
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02980653
First Posted
July 25, 2016
Last Updated
January 16, 2017
Sponsor
TTY Biopharm
Collaborators
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02980653
Brief Title
Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&N Cancer Who Receiving CCRT
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TTY Biopharm
Collaborators
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Phase II study, Critical body weight loss, Concurrent chemoradiotherapy, Megestrol acetate, Head and neck cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Megestrol
Arm Type
Experimental
Arm Description
Single arm
Intervention Type
Drug
Intervention Name(s)
Megestrol acetate (MA) 400 mg/day
Other Intervention Name(s)
Megest
Intervention Description
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.
Primary Outcome Measure Information:
Title
Critical body weight loss
Description
To evaluate the population prevalence of critical body weight loss ( > 5% from baseline) in patients with Head and Neck cancer
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Impact of appetite
Description
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.
Time Frame
12 weeks
Title
Impact of performance status
Description
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.
Time Frame
12 weeks
Title
Change of quality of life (QoL)
Description
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.
Time Frame
12 weeks
Title
Incidence of infection and hospitalization
Description
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.
Time Frame
12 weeks
Title
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)
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Measurability of Anthropometric Evaluation
Description
Anthropometric evaluation is including body weight and body mass index.
Time Frame
12 weeks
Title
Lab test
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Ming Wang, M.D.
Phone
+886 3 3281200
Ext
8825
Email
whm526@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Hsun Hsieh, M.D.
Phone
+886 3 3281200
Ext
2114
Email
wisdom5000@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Ming Wang, M.D.
Organizational Affiliation
Chang Gung Memorial Hospital, Linkou, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang-Gung Memorial Hospital, Linkou
City
Linkou
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
21128029
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.
Results Reference
background
PubMed Identifier
9708631
Citation
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.
Results Reference
background
PubMed Identifier
15050664
Citation
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.
Results Reference
background
PubMed Identifier
21296615
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. Epub 2011 Feb 4.
Results Reference
background
PubMed Identifier
11929007
Citation
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.
Results Reference
background
PubMed Identifier
11332139
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. doi: 10.1023/a:1011156811739.
Results Reference
background
PubMed Identifier
9137798
Citation
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.
Results Reference
background
PubMed Identifier
9893656
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. doi: 10.1016/s0959-8049(98)00219-6.
Results Reference
background
PubMed Identifier
8664133
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. doi: 10.1038/bjc.1996.297.
Results Reference
background
PubMed Identifier
8478668
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. doi: 10.1200/JCO.1993.11.4.762.
Results Reference
background
PubMed Identifier
1739926
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. doi: 10.1002/cncr.2820690532.
Results Reference
background
PubMed Identifier
12937858
Citation
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.
Results Reference
background
PubMed Identifier
19360748
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.
Results Reference
background
PubMed Identifier
18475213
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.
Results Reference
background
PubMed Identifier
24415363
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. Epub 2014 Mar 25.
Results Reference
background
PubMed Identifier
18098310
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. doi: 10.1002/hed.20737.
Results Reference
background
PubMed Identifier
8562975
Citation
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.
Results Reference
background
PubMed Identifier
21760776
Citation
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.
Results Reference
background
PubMed Identifier
23031071
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.
Results Reference
background
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Megestrol Acetate Against Cancer-related Critical Body Weight Loss in Patients With H&N Cancer Who Receiving CCRT
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