Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.

NCT06772428 | Not Yet Recruiting Phase 3

• 1 other identifier: Megaxia ES-HNSCC-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.

Conditions

Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects with improved appetite based on A/CS-12 assessment

  Week 3

• The proportion of subjects with a relative increase in body weight of >5% from baseline

  Week 12

Study Arms (2)

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy

EXPERIMENTAL

Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Radiation: standard treatment

Standard Therapy

ACTIVE COMPARATOR

Radiation: standard treatment

Interventions

Nano-crystalline Megestrol Acetate Oral Suspension DRUG

Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy.

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy

standard treatment RADIATION

radiotherapy ± chemotherapy

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy; Standard Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years at the time of enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Life expectancy ≥6 months.
• Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, and hypopharynx).
• Patients who have undergone surgery for head and neck squamous cell carcinoma within 6 weeks and are assessed postoperatively as having high-risk factors requiring radiotherapy ± chemotherapy.

You may not qualify if:

• Suffering from tumors in areas other than the oral cavity, oropharynx, larynx, and hypopharynx, such as nasopharyngeal carcinoma or other unknown primary head and neck tumors.
• Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting; currently undergoing tube feeding or parenteral nutrition.
• Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
• Suffering from Acquired Immune Deficiency Syndrome (AIDS).

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

Central Study Contacts

Qiongwen Zhang

CONTACT

18683716951; qiongwen.zhang@scu.edu.cn

Qi Rao

CONTACT

13870440265; raoqi6543@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 13, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

CN (1)