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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia Multicenter Observational Study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Nanocrystalline Megestrol Acetate

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Henan Cancer Hospital, Affiliated to Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Suxia Luo

Role: CONTACT

18638553211

Facility Contacts

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Suxia Luo

Role: primary

18638553211

Other Identifiers

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Megaxia-RWS 01

Identifier Type: -

Identifier Source: org_study_id

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