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

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Jan 8, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with high-risk squamous cell carcinoma of the head and neck, which is a type of cancer that can occur in areas like the mouth and throat. The study will compare a medication called nano-crystalline megestrol acetate, combined with standard treatments, to standard treatment alone after patients have had surgery. The goal is to see if the new medication helps improve outcomes for patients who are at higher risk of their cancer returning after surgery.

To be eligible for this trial, participants must be at least 18 years old, have undergone surgery for their cancer within the last six weeks, and have been assessed as having high-risk factors that require further treatment. Patients will need to be generally healthy enough to participate and not have certain other medical conditions that could interfere with the study. While the trial is not yet recruiting participants, those who join can expect close monitoring and care as part of the research process, contributing to our understanding of how to improve treatment for this challenging condition.

Gender

ALL

Eligibility criteria

• 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).