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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Not yet enrolling; Phase 3

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06772428

Megaxia ES-HNSCC-01

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy

Experimental group

Treatment:

Radiation: standard treatment

Drug: Nano-crystalline Megestrol Acetate Oral Suspension

Standard Therapy

Active Comparator group

Treatment:

Radiation: standard treatment