A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
NCT ID: NCT07243379
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
495 participants
INTERVENTIONAL
2025-09-25
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy
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.
Nanocrystalline Megestrol Acetate
Nanocrystalline Megestrol Acetate oral suspension, with a specification of 125 mg/mL, administered orally at a dose of 5 mL per day (625 mg/day), and the primary endpoint efficacy collection will be conducted in the 4th week.
Interventions
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Nanocrystalline Megestrol Acetate
Nanocrystalline Megestrol Acetate oral suspension, with a specification of 125 mg/mL, administered orally at a dose of 5 mL per day (625 mg/day), and the primary endpoint efficacy collection will be conducted in the 4th week.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Henan Cancer Hospital, Affiliated to Zhengzhou University
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Megaxia-RWS 01
Identifier Type: -
Identifier Source: org_study_id
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