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

This study is currently recruiting participants.
Verified January 2017 by TTY Biopharm
Sponsor:
ClinicalTrials.gov Identifier:
NCT02980653
First Posted: December 2, 2016
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
TTY Biopharm
  Purpose

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


Condition Intervention Phase
Head and Neck Cancer Drug: Megestrol acetate (MA) 400 mg/day Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by TTY Biopharm:

Primary Outcome Measures:
  • Critical body weight loss [ Time Frame: 12 weeks ]
    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 [ Time Frame: 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.

  • Impact of performance status [ Time Frame: 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.

  • Change of quality of life (QoL) [ Time Frame: 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.

  • Incidence of infection and hospitalization [ Time Frame: 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.

  • 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) [ Time Frame: 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.


Other Outcome Measures:
  • Measurability of Anthropometric Evaluation [ Time Frame: 12 weeks ]
    Anthropometric evaluation is including body weight and body mass index.

  • Lab test [ Time Frame: 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.


Estimated Enrollment: 105
Study Start Date: May 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Megestrol
Single arm
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.
Other Name: Megest

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980653


Contacts
Contact: Hung-Ming Wang, M.D. +886 3 3281200 ext 8825 whm526@gmail.com
Contact: Chia-Hsun Hsieh, M.D. +886 3 3281200 ext 2114 wisdom5000@gmail.com

Locations
Taiwan
Chang-Gung Memorial Hospital, Linkou Recruiting
Linkou, Taiwan
Sponsors and Collaborators
TTY Biopharm
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Hung-Ming Wang, M.D. Chang Gung Memorial Hospital, Linkou, Taiwan
  More Information

Publications:

Responsible Party: TTY Biopharm
ClinicalTrials.gov Identifier: NCT02980653     History of Changes
Other Study ID Numbers: TTYMG1403
First Submitted: July 25, 2016
First Posted: December 2, 2016
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by TTY Biopharm:
Phase II study
Critical body weight loss
Concurrent chemoradiotherapy
Megestrol acetate
Head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Weight Loss
Body Weight
Neoplasms by Site
Neoplasms
Body Weight Changes
Signs and Symptoms
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants