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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

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06909383
Enrollment
41
Registered
2025-04-03
Start date
2025-06-01
Completion date
2026-12-31
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer - Associated Anorexia - Cachexia Syndrome, Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Brief 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.

Interventions

Nanocrystalline megestrol acetate

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients who have been confirmed by histological or cytological examination to have small cell lung cancer (SCLC), and who have been identified as having extensive-stage small cell lung cancer based on the 8th edition of the AJCC staging system or the Veterans Administration Lung Group (VALG) criteria (excluding patients with combined small cell lung cancer). The subjects have not received systemic chemotherapy for metastatic diseases in the past. For subjects who have previously received adjuvant/neoadjuvant chemotherapy aimed at cure for non-metastatic diseases, or radical concurrent or sequential chemoradiotherapy, if the disease progression occurs more than 6 months after the end of the last treatment, they are eligible to participate in this study. According to RECIST v1.1, there is at least one measurable tumor lesion. Meet the diagnostic criteria for the pre-cachexia or cachexia stage. -

Exclusion criteria

1. Cancer-specific

Design outcomes

Primary

MeasureTime frame
The proportion of subjects with a body weight increase of more than 5% relative to the baselineat the 12th week

Contacts

Primary ContactChengzhi Zhou
86+13560351186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026