Effect of Vitamin D Supplementation on Chemotherapy Side Effects After Adjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence and proportion of treatment-related adverse events
研究概览
简要总结
This randomized controlled Phase III trial was designed to evaluate the effect of vitamin D supplementation (VD) on chemotherapy side effects following adjuvant chemotherapy in breast cancer
详细描述
This is a parallel group, open-label randomized controlled trial to investigate the occurrence of side effects of vitamin D supplementation (VD) in adjuvant chemotherapy in patients with breast cancer. Both groups will receive standard adjuvant chemotherapy on day 1 and each subsequent cycle. In addition, vitamin D2 will be given randomly to both groups. Blood samples and imaging results were collected and analyzed before initiation of adjuvant chemotherapy and after every two cycles. The primary outcome to be documented was associated grade III or higher adverse events during adjuvant chemotherapy. Primary and secondary study findings and adverse events will be thoroughly evaluated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Primary diagnosis of breast cancer confirmed by preoperative pathological examination.
- •Serum 25(OH)D levels less than 20 ng/ml (50 nmol/L).
- •Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of
- •Patients with adjuvant chemotherapy or combined targeted therapy.
- •Life expectancy of at least 6 months.
- •No other uncontrolled benign diseases at the time of recruitment.
- •All patients must have complete clinical medical records.
- •Willingness to voluntarily sign an informed consent form.
排除标准
- •History of invasive breast cancer.
- •Prior systemic treatment for the treatment or prevention of breast cancer.
- •Known allergic reactions to vitamin D or calcium compounds.
- •Comorbidities that may affect vitamin D or calcium balance or bone health.
- •Vitamin D or calcium supplementation in the past 3 months.
- •Presence of other tumors.
- •Pregnant or lactating women.
- •Individuals who do not wish to participate in the study.
研究组 & 干预措施
Chemotherapy + vitamin D2
Before the start of treatment and every 3 weeks thereafter, participants will receive a 10-milligram dose of vitamin D2 injection until adjuvant chemotherapy is completed. They will receive a standard adjuvant chemotherapy regimen, which includes 10 mg of vitamin D2 injections per cycle during treatment. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.
干预措施: Chemotherapy + vitamin D2 (Drug)
chemotherapy
Participants will receive a standard adjuvant chemotherapy regimen for each adjuvant chemotherapy cycle. The dosage of adjuvant chemotherapy drugs can be customized according to the clinical judgment of the doctor.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Incidence and proportion of treatment-related adverse events
时间窗: 4-6months
The occurrence of side effects between the two groups from the first to the last chemotherapy
次要结局
- Evaluation of side effects associated with adjuvant therapy (CTCAE v5.0)(From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.)
- Assessment of side effects associated with adjuvant therapy (EQ-5D Health Status Scale)(From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.)
- Assessment of side effects associated with adjuvant therapy (Abbreviated Fatigue Scale)(From the start of adjuvant therapy to 21 days after the last adjuvant therapy cycle.)
研究者
Jiuda Zhao
Breast Disease Diagnosis and Treatment Center
Affiliated Hospital of Qinghai University