Clinical Characteristics and Treatment Outcomes of Malignant Tumor CachexiaPhase 4NCT07243379
A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
A Phase 4 study testing Nanocrystalline Megestrol Acetate in people with Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia and Multicenter Observational Study, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia, Multicenter Observational Study
- What is being tested?
- Nanocrystalline Megestrol Acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital, Affiliated to Zhengzhou University
Zhengzhou, Henan, 45000
Suxia Luo, 18638553211, luosxrm@163.com
About this study
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
- Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia, Multicenter Observational Study
- Being tested
- Nanocrystalline Megestrol Acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanocrystalline Megestrol AcetateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy | Experimental | 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. Receives: Drug: Nanocrystalline Megestrol Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.
Measured: Week 4
Secondary outcomes (1)
Proportion of patients with >5% increase in body weight from baseline at Week 4, Week 8, and Week 12.
Measured: Proportion of patients with >5% increase in body weight from baseline to week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Characteristics and Treatment Outcomes of Malignant Tumor CachexiaStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henan Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243379
- Sponsor's protocol ID
- Megaxia-RWS 01
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Real-World Observational Study of Nanocrystalline Megestrol Acetate in Patients With Cancer Cachexia
- ClinicalTrials.gov ID
- NCT07243379
- Acronym / sponsor ID
- Megaxia-RWS 01
- Conditions
- Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia, Multicenter Observational Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Henan Cancer Hospital
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy | Experimental | Drug: Nanocrystalline Megestrol AcetateThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanocrystalline Megestrol AcetateNanocrystalline 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. | Drug | Nanocrystalline Megestrol Acetate Oral Suspension + Standard Antitumor Therapy |
Primary outcome
Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale.
Time frame: Week 4
1 secondary outcome
Proportion of patients with >5% increase in body weight from baseline at Week 4, Week 8, and Week 12.
Time frame: Proportion of patients with >5% increase in body weight from baseline to week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nanocrystalline Megestrol Acetate in people with Clinical Characteristics and Treatment Outcomes of Malignant Tumor Cachexia and Multicenter Observational Study, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suxia Luo (18638553211, luosxrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with improved appetite at Week 4 based on the A/CS-12 scale. (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.