Evaluating Nano-Crystalline Megestrol Acetate for Cachexia in Advanced Digestive Tumors
A Multicenter, Real-World Study on Nano-Crystalline Megestrol Acetate for Cachexia in Patients With Advanced Digestive System Tumors Receiving TKI-Based Therapy
This study is testing if a new form of Megestrol Acetate can help adults with advanced digestive tumors gain weight and feel better while they are on cancer treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Shenyang, Liaoning and 1 other locations) |
| Trial ID | NCT06940102 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of Nano-Crystalline Megestrol Acetate in treating cachexia among patients with advanced digestive system tumors who are undergoing TKI-based therapy. Participants will be monitored for their response to the treatment, focusing on improvements in weight and overall health. The study will include adults aged 18 and older with specific cancer diagnoses and performance status. It seeks to gather real-world data on the impact of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced digestive system tumors experiencing cachexia and receiving TKI-based therapy.
Not a fit: Patients with gastrointestinal obstruction or those whose anorexia is caused by mental illness or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life and nutritional status of patients suffering from cachexia due to advanced digestive tumors.
How similar studies have performed: While there is limited data on this specific approach, similar studies using Megestrol Acetate for cachexia have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntarily sign a written informed consent (ICF). * Age ≥ 18 years at enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Life expectancy ≥ 3 months. * Histologically or cytologically confirmed locally advanced or metastatic digestive system tumors that are not amenable to curative treatment, according to the 8th edition TNM staging classification. * Not benefiting from local anticancer therapies such as surgery, local ablation, or chemoembolization, and planned to receive TKI-based anticancer treatment, which may be combined with chemotherapy or immunotherapy). * Meet the diagnostic criteria for pre-cachexia or cachexia (based on Fearon diagnostic criteria). * Good organ function determined Exclusion Criteria: * Gastrointestinal obstruction. * Anorexia due to difficulty in eating caused by neurosis, mental illness, or pain. * Comorbidities such as severe cerebrovascular, cardiac, renal, or liver diseases. * Major surgery or trauma within the last month. * Allergy to any component of the investigational drug. * Other conditions deemed unsuitable by the investigator.
Where this trial is running
Shenyang, Liaoning and 1 other locations
- General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Recruiting)
- Liaoning Cancer Hospital — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Cheng Du — The General Hospital of Northern Theater Command
- Study coordinator: Cheng Du
- Email: dc1115010@sina.com
- Phone: 024-28851942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.