Clinical trial · Interventional
A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
NCT07243379CI-TRIAL-00097747recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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, real-world observational study. The objective is to evaluate the effectiveness and safety of nanocrystalline megestrol acetate in patients with cancer cachexia in real-world settings. Eligible participants were patients diagnosed with cancer cachexia who were scheduled to receive treatment with nanocrystalline megestrol acetate.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia | — | UNRESOLVED | — |
| Multicenter Observational Study | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nanocrystalline Megestrol Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy
- description
- This cohort focuses on patients who have already been diagnosed with cachexia before the initiation of this study and are scheduled to receive treatment with nanocrystalline megestrol acetate.
- interventionNames
- Drug: Nanocrystalline Megestrol Acetate
Primary outcomes (1)
- measure
- Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.
- timeFrame
- Week 4
Secondary outcomes (1)
- measure
- Proportion of patients with >5% increase in body weight from baseline at Week 4, Week 8, and Week 12.
- timeFrame
- Proportion of patients with >5% increase in body weight from baseline to week 12.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically and/or cytologically confirmed malignancy. * Age ≥18 years at enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and an expected survival of ≥3 months. * Meeting the diagnostic criteria for cachexia (based on Fearon's criteria). * Body mass index (BMI) ≤30. Exclusion Criteria: * Presence of any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrolled vomiting; patients receiving tube feeding or parenteral nutrition. * Presence of anorexia due to anorexia nervosa, psychiatric disorders, or pain that makes eating difficult. * Patients with acquired immunodeficiency syndrome (AIDS). * Currently receiving or planning to receive other medications that increase appetite or body weight, such as corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants. * Patients with Cushing's syndrome, adrenal or pituitary insufficiency, or poorly controlled diabetes mellitus.
References
Publications (0)
Data not yet available
No reference posted for this study.