Adjunctive Intravenous Ascorbic Acid for Advanced Non-Small Cell Lung Cancer: A Double Blind, Placebo Controlled, Phase II Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
This is a two arm RCT evaluating the effect of intravenous vitamin C versus placebo in patients with incurable non-small cell lung cancer. Participants in both arms will be receiving platinum doublet chemotherapy with or without concurrent immunotherapy as standard care. We plan to enroll 90 patients over 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years of age) seen at TOHCC with stage IIIB or IV primary non-small cell lung cancer
- •Eligible and scheduled for first line platinum-doublet chemotherapy with or without concurrent immunotherapy
排除标准
- •ECOG status greater than 2
- •Previously received IVC within 6 months prior to randomization
- •Biochemical deficiency in G6PD
- •Estimated Glomerular Filtration Rate (eGFR) less than 45 mL/min
- •Currently taking insulin or warfarin
- •History of severe renal dysfunction or hemochromatosis
- •Previously undergone cytotoxic chemotherapy or immunotherapy within 12 months prior to randomization
- •If pregnant or planning to become pregnant: not a carrier of the gene for G6PD deficiency
- •Currently taking an investigational product or participation in an investigational study within the past 30 days
- •Any reason which, under the discretion of the Principal Investigator or delegate, would preclude the patient from participating
研究组 & 干预措施
Intravenous Vitamin C
1g/kg IVC administered twice weekly for 6 months.
干预措施: Ascorbic acid (Drug)
Normal Saline
Equivalent volume normal saline administered twice weekly for 6 months.
干预措施: Normal Saline (Other)
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline, Chemo cycles 1-4, 6 months, 12 months
Participant reported quality of life (QOL) measured using the Functional Assessment of Cancer Therapy - Lung (FACT-L). FACT-L is a validated tool for assessing QOL in patients with lung cancer. FACT scores are normalized to values between 0-100, where 0 is the worst QOL and 100 is the best QOL imaginable. Each chemotherapy cycle is 3 weeks in length.
次要结局
- Frequency of Discontinuation of Chemotherapy(6 months)
- Change in C-Reactive Protein Levels(Baseline, chemo cycles 1-4, 6 months, 12 months)
- Safety(6 months)
- Chemotherapy-Related Toxicities(12 months)
- Change in General Symptom Burden(Baseline, chemo cycles 1-4, 6 months, 12 months)
- Survival(24 months)
- Tumour Progression(12 months)
- Cytotoxicity(12 months)