Clinical trial · Interventional
Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
- 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, primarily aimed at evaluating the efficacy and safety of Nanocrystalline Megestrol Acetate combined with standard therapy, compared with placebo combined with standard therapy, in improving appetite and body weight during concurrent chemoradiotherapy for patients with locally advanced non-small cell lung cancer.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension | Drug | — | UNRESOLVED |
| Standard Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy
- interventionNames
- Drug: Nano-crystalline Megestrol Acetate Oral Suspension
- Other: Standard Therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo+ Standard Therapy
- interventionNames
- Other: Standard Therapy
Primary outcomes (2)
- measure
- Proportion of appetite decrease assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)
- timeFrame
- over an 8-week period
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily provide written informed consent (ICF). 2. Age ≥ 18 years at enrollment. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 4. Expected survival ≥ 6 months. 5. Histologically or cytologically confirmed, unresectable or inoperable locally advanced (stage III) non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC). 6. Planned to receive radical concurrent chemoradiotherapy. 7. Body mass index (BMI) ≤ 25. 8. At least one measurable tumor lesion according to RECIST v1.1. Exclusion Criteria: 1. Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain. 2. Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants. 3. Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes. 4. Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (\>15 mm) within one year. 5. Current radiological or clinical evidence of gastrointestinal obstruction.
References
Publications (0)
Data not yet available