Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Официальное название

A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

Обзор

This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the efficacy and safety of Nanocrystalline Megestrol Acetate combined with standard therapy, compared with placebo combined with standard therapy, in improving appetite and body weight during concurrent chemoradiotherapy for patients with locally advanced non-small cell lung cancer.

Вмешательства

• Препарат Nano-crystalline Megestrol Acetate Oral Suspension
  Nanocrystalline Megestrol Acetate Oral Suspension Nanocrystalline Megestrol Acetate Oral Suspension (125 mg/mL) was administered to the study group at 5 mL orally once daily (equivalent to 625 mg/day) until disease progression or completion of 8 weeks (maximum treatment duration: 8 weeks), whichever occurred first.
• Другое Standard Therapy
  Standard Therapy

Первичные конечные точки

• Proportion of appetite decrease assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy) [Срок оценки: over an 8-week period]
• Proportion of individuals with weight loss exceeding 5% relative to baseline [Срок оценки: over an 8-week period]

Критерии участия

Критерии включения

• Voluntarily provide written informed consent (ICF).
• Age ≥ 18 years at enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Expected survival ≥ 6 months.
• Histologically or cytologically confirmed, unresectable or inoperable locally advanced (stage III) non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
• Planned to receive radical concurrent chemoradiotherapy.
• Body mass index (BMI) ≤ 25.
• At least one measurable tumor lesion according to RECIST v1.1.

Критерии исключения

• Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain.
• Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
• Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.
• Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (>15 mm) within one year.
• Current radiological or clinical evidence of gastrointestinal obstruction.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, TongjiMedical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07150663 · Megaxia CRT-NSCLC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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