Nanocrystalline Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome in Extensive-St… (NCT06909383) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Nanocrystalline Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome in Extensive-Stage Small Cell Lung Cancer: A Prospective, Open-Label, Single-Arm Phase II Clinical Study
41 participantsStarted 2025-06-01
Plain-language summary
Patients with extensive-stage small cell lung cancer are a high-risk group for cancer cachexia and anorexia. Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and development of cancer cachexia and anorexia. Cancer cachexia and anorexia also severely affect the quality of life of patients with extensive-stage small cell lung cancer, significantly shortening their overall survival (OS) and progression-free survival (PFS), thus forming a vicious cycle.
Numerous previous studies have shown that for patients with advanced tumors, the combination of supportive treatments such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy is a treatment mode with clinical significance and practical feasibility in clinical practice. However, the efficacy and the optimal treatment timing of its combination with the current first-line immunochemotherapy regimen remain unclear. Although mechanistic studies have shown that anti-cachexia treatment may synergistically enhance the efficacy of immunotherapy, there is a lack of relevant clinical research evidence.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Cancer-specific exclusion criteria:
. Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) determined by CT or magnetic resonance imaging (MRI) evaluation during screening and previous imaging evaluations. Patients who have previously received treatment for brain or leptomeningeal metastases, have been stable for ≥ 2 months, and have discontinued systemic hormonal therapy (\> 10 mg/day of prednisone or equivalent) for \> 4 weeks before randomization may participate in the study.
. Uncontrolled tumor-related pain;
. Thromboembolic disease, ascites, or lower extremity edema within the past 6 months;
. A history of malignant tumors other than lung cancer within 5 years before random assignment, except for malignant tumors with a negligible risk of metastasis or death \[e.g., with an expected 5-year overall survival rate \> 90%\] and those expected to be cured after treatment, such as appropriately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of subjects with a body weight increase of more than 5% relative to the baseline
. Persistent toxicity from previous anti-tumor treatment that has not been resolved. "Not resolved" is defined as not having recovered to grade 0 or 1 according to NCI CTCAE version 5.0 (excluding alopecia) or not having recovered to the level specified in the inclusion/exclusion criteria.
. General medical exclusion criteria:
. Women who are pregnant, lactating, or planning to become pregnant during the study period;