Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Xuhui District, No. 270, Dong'An Road, Shanghai, 200032, China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China.
Trials. 2024 Jul 29;25(1):512. doi: 10.1186/s13063-024-08345-w.
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.
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.
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.
The trial was registered with the ClinicalTrials.gov (NCT06018883) on August 31, 2023.
在治疗晚期胰腺癌方面，化疗发挥着关键作用。尽管这种治疗方案有效，但往往会带来贫血、神经病变、疲劳、恶心和营养不良等副作用，这会显著影响患者对治疗的耐受性。一些研究表明，维生素 C 可能通过提高铁的吸收、改善贫血以及缓解手脚疼痛和麻木等方式，提高化疗的耐受性。然而，迄今为止，尚无随机对照试验研究维生素 C 与化疗联合应用以减轻毒性副作用并提高晚期胰腺癌患者的生活质量。
一项由复旦大学附属肿瘤医院开展的、前瞻性的、单中心、开放标签、随机对照临床试验，将在 2023 年 9 月至 2026 年 9 月进行。将招募至少 100 例患有远处转移的晚期胰腺腺癌患者，并将其随机分配至化疗组或化疗加维生素 C 组。主要终点为贫血发生率。次要终点包括 3 级神经病变发生率、数字评分量表变化、生活质量和总生存期。
本研究旨在评估低剂量维生素 C 对提高接受吉西他滨和白蛋白紫杉醇化疗的转移性胰腺癌患者生活质量的影响。
该试验于 2023 年 8 月 31 日在 ClinicalTrials.gov（NCT06018883）注册。
