Clinical trial · Interventional
Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension | Drug | — | UNRESOLVED |
| standard treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy
- interventionNames
- Drug: Nano-crystalline Megestrol Acetate Oral Suspension
- Radiation: standard treatment
- type
- ACTIVE_COMPARATOR
- label
- Standard Therapy
- interventionNames
- Radiation: standard treatment
Primary outcomes (2)
- measure
- The proportion of subjects with improved appetite based on A/CS-12 assessment
- timeFrame
- Week 3
- measure
- The proportion of subjects with a relative increase in body weight of >5% from baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available