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

Phase 3

Not yet recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors
• Interventions: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Radiation: standard treatment

• Registration Number: NCT06772428
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-25
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• ≥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.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy	Nano-crystalline Megestrol Acetate Oral Suspension	-
Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy	standard treatment	-
Standard Therapy	standard treatment	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

West China School of Medicine/West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China