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

January 16, 2017 updated by: 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Linkou, Taiwan
        • Recruiting
        • Chang-Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Megest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
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)
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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurability of Anthropometric Evaluation
Time Frame: 12 weeks
Anthropometric evaluation is including body weight and body mass index.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TTY Biopharm

Collaborators

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Hung-Ming Wang, M.D., Chang Gung Memorial Hospital, Linkou, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTYMG1403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on Megestrol acetate (MA) 400 mg/day

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe