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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

NCT06909383 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-04-03

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Nanocrystalline megestrol acetate

Nanocrystalline megestrol acetate

Sponsors & Collaborators

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-06-01
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909383 on ClinicalTrials.gov