Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group.
研究概览
简要总结
This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D levels will be checked throughout supplementation then followed for 5 years with occasional Vitamin D testing and surveying in order to collect information on recurrence and survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Willing to stop herbal medications as directed by physician
- •Willing to stop current supplemental Vitamin D (Multivitamin with Vitamin D component is acceptable)
- •Willing to travel to Legacy Health/OHSU facility if necessary
- •Agree to attend study visits outside of standard of care visits, if necessary
- •Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started
- •Baseline serum Vitamin D level below 52 ng/ml
排除标准
- •≤ 18 years of age
- •Colon cancer stages I-II and IV or Rectal cancer stage I or IV
- •Patients who do not undergo chemotherapy
- •Patients with prior chemotherapy for this cancer
- •No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for > 3 years
- •Unable to comply with protocol
- •Unable to provide written informed consent
- •Unwilling or unable to stop oral supplemental Vitamin D
- •Patients taking high-dose Vitamin D supplementation (50,000 IU weekly) prior to enrollment
- •Patients with Vitamin D levels above 52 ng/ml at baseline testing
- •Patients with hypercalcemia and/or any condition resulting in malabsorption
- •Investigator does not believe study participation, for any reason, is in the best interest of the patient
结局指标
主要结局
Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group.
时间窗: 1 year
次要结局
- Relapse-free survival (RFS)(5 years)
- Overall survival (OS)(5 years)
研究者
Eric Anderson
Principal Investigator
Legacy Health System