Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nano-crystalline Megestrol Acetate Oral Suspension, standard treatment.
- Who it may be relevant to
- Registry conditions: Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for Adjuvant Therapy in Patients With High-risk Factor Squamous Cell Carcinoma of the Head and Neck After Surgery.
Overview
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.
Interventions
- Drug Nano-crystalline Megestrol Acetate Oral Suspension
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. - Radiation standard treatment
radiotherapy ± chemotherapy
Primary outcome measures
- The proportion of subjects with improved appetite based on A/CS-12 assessment [Time frame: Week 3]
- The proportion of subjects with a relative increase in body weight of >5% from baseline [Time frame: Week 12]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China School of Medicine/West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT06772428 · Megaxia ES-HNSCC-01