背景:在晚期胰腺癌的治疗中,化疗起着举足轻重的作用。尽管有效,这种方案通常会受到贫血等副作用的损害,神经病,疲劳,恶心,营养不良,显著影响患者对治疗的耐受性。一些研究表明,维生素C可能会增加化疗的耐受性,特别是通过促进铁的吸收,改善贫血,减轻手脚的疼痛和麻木。然而,迄今为止,尚未在任何随机对照试验中研究将维生素C与化疗相结合以减轻晚期胰腺癌患者的毒副作用并提高生活质量.
方法:前瞻性,单中心,开放标签,随机对照试验将于2023年9月至2026年9月在复旦大学上海肿瘤中心进行.将招募至少100名表现出远处转移的晚期胰腺腺癌患者,并将其随机分配到化疗组或化疗加维生素C组。主要终点是贫血率。次要终点包括3级神经病的发生率,数字评级量表的变化,生活质量,和总体生存率。
结论:本研究旨在评估低剂量维生素C对接受吉西他滨和nab-紫杉醇化疗的转移性胰腺癌患者生活质量的影响。
背景:该试验于2023年8月31日在ClinicalTrials.gov(NCT06018883)注册。
BACKGROUND: In the treatment of advanced pancreatic cancer, chemotherapy plays a pivotal role. Despite its effectiveness, this regimen is often marred by side effects such as anemia, neuropathy, fatigue, nausea, and malnutrition, which significantly affect patients\' tolerance to the treatment. Some studies have shown that vitamin C could potentially augment chemotherapy\'s tolerability, notably by boosting iron absorption, ameliorating anemia, and relieving pain and numbness in hands and feet. Nevertheless, the integration of vitamin C with chemotherapy to mitigate toxic side effects and enhance the quality of life for advanced pancreatic cancer patients has not been examined in any randomized controlled trials to date.
METHODS: A prospective, single-center, open-label, randomized controlled trial will be conducted at Fudan University Shanghai Cancer Center from September 2023 to September 2026. A total of at least 100 patients with advanced pancreatic adenocarcinoma exhibiting distant metastases will be recruited and randomly assigned to the chemotherapy group or the chemotherapy plus vitamin C group. The primary endpoint is the rate of anemia. Secondary endpoints include the rate of grade 3 neuropathy, change of numeric rating scale, quality of life, and overall survival.
CONCLUSIONS: This study aims to assess the impact of low-dose vitamin C on enhancing the quality of life for patients with metastatic pancreatic cancer undergoing gemcitabine and nab-paclitaxel chemotherapy.
BACKGROUND: The trial was registered with the ClinicalTrials.gov (NCT06018883) on August 31, 2023.