Prospective Double Blind Study of the Effect of Intravenous High Dose Ascorbic Acid in Women Receiving Adjuvant or Neo-Adjuvant Chemotherapy for Early Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Fatigue by self reported fatigue inventory questionnaire
研究概览
简要总结
This is a parallel-track, randomized study will observe whether intravenous ascorbic acid reduces the reported fatigue in women receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- •Diagnosed early stage breast cancer and scheduled to receive either adjuvant or neo-adjuvant chemotherapy;
- •Willing to receive either intravenous ascorbic acid or normal saline;
- •Willing to use an acceptable contraceptive method for the duration of the study and for 30 days following the last dose of study drug;
- •Negative urine or serum pregnancy test within 2 weeks prior to receipt of study drug;
- •Willing to complete all evaluation tools;
- •Able to give informed consent to participate in the study; and
- •Agree to avoid any additional supplemental ascorbic acid throughout the study.
排除标准
- •Diagnosed Glucose-6-phosphate dehydrogenase deficiency;
- •Renal insufficiency (Blood Urea Nitrogen >30 mg/dL, or Creatinine >1.5 mg/dL);
- •Unwillingness or mental incapacity to complete self-reported questionnaires;
- •Active smoker; and
研究组 & 干预措施
Odd Cycle Intravenous Ascorbic Acid
Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their odd-numbered chemotherapy cycles. During the even-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%).
干预措施: Ascorbic Acid (Drug)
Odd Cycle Intravenous Ascorbic Acid
Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their odd-numbered chemotherapy cycles. During the even-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%).
干预措施: Normal Saline (Other)
Even Cycle Intravenous Ascorbic Acid
Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their even-numbered chemotherapy cycles. During the odd-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%).
干预措施: Ascorbic Acid (Drug)
Even Cycle Intravenous Ascorbic Acid
Women randomized to this study arm will receive intravenous ascorbic acid (50g in 500 ml sterile water) prior to their even-numbered chemotherapy cycles. During the odd-numbered chemotherapy cycles, these subjects will receive intravenous normal saline (0.9%).
干预措施: Normal Saline (Other)
结局指标
主要结局
Fatigue by self reported fatigue inventory questionnaire
时间窗: Day 8 of each 4-week treatment cycle.
Patients will complete the validated questionnaire Fatigue Symptom Inventory (FSI)
次要结局
- Fatigue ( EORTC QLQ-FA13)(Day 15 of each 4-week treatment cycle.)
- Fatigue by self reported fatigue inventory questionnaire(Day 15 of each 4-week treatment cycle.)
研究者
Dennis Citrin, MD
Medical Oncologist
Midwestern Regional Medical Center