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

NCT02980653 | Unknown Phase 2

• 1 other identifier: TTYMG1403
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Cancer

Keywords

Phase II study; Critical body weight loss; Concurrent chemoradiotherapy; Megestrol acetate; Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Impact of appetite

  12 weeks

• Impact of performance status

  12 weeks

• Change of quality of life (QoL)

  12 weeks

• Incidence of infection and hospitalization

  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)

  12 weeks

Other Outcomes (2)

• Measurability of Anthropometric Evaluation

  12 weeks

• Lab test

  12 weeks

Study Arms (1)

Megestrol

EXPERIMENTAL

Single arm

Drug: Megestrol acetate (MA) 400 mg/day

Interventions

Megestrol acetate (MA) 400 mg/day DRUG

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.

Also known as: Megest

Megestrol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TTY Biopharm: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Chang-Gung Memorial Hospital, Linkou

Linkou District, Taiwan

RECRUITING

Related Publications (19)

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  PMID: 11332139 BACKGROUND

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  PMID: 8664133 BACKGROUND

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MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hung-Ming Wang, M.D.

  Chang Gung Memorial Hospital, Linkou, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Ming Wang, M.D.

CONTACT

+886 3 3281200; whm526@gmail.com

Chia-Hsun Hsieh, M.D.

CONTACT

+886 3 3281200; wisdom5000@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: December 2, 2016
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

TW (1)