The Effect of Vitamin D Supplementation in Breast Cancer Patients Receiving Taxane-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The cumulative incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)
研究概览
简要总结
It is a randomized clinical trial aimed at exploring the neuroprotective effect of vitamin D3 (Cholecalciferol) supplementation in conjunction with paclitaxel-based chemotherapy among breast cancer patients with vitamin D insufficiency or deficiency.
详细描述
This study is a two-arm randomized controlled trial with 132 participants, evenly randomized into an intervention group and a control group. Both groups are scheduled to receive Adriamycin-Cyclophosphamide followed by paclitaxel (AC-T) chemotherapy protocol. The intervention group will undergo paclitaxel-based chemotherapy, along with vitamin D replacement therapy. Conversely, the control group will follow the AC-T protocol without the addition of vitamin D replacement therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the neurologist conducting the Modified Total Neuropathy Score (mTNS) assessment will be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18 to 65 years old.
- •Histologically confirmed breast cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 [21] [22].
- •All patients should fulfill the criteria of the initiation of taxane-based chemotherapy such as absolute neutrophil count (ANC) > 1,500/mcL, platelets > 100,000/mcL, hemoglobin ≥ 9 g/mL, Aspartate Aminotransferase (AST) (Serum Glutamic-Oxaloacetic Transaminase) (SGOT) to Alanine Aminotransferase (ALT), (Serum Glutamic-Pyruvic Transaminase) (SGPY) ratio (AST (SGOT)/ALT (SGPT)) < 2.5 x institutional upper limit of normal (ULN), total bilirubin less than or equal to 1.5 x institutional ULN, serum creatinine < 1.5 x institutional ULN.
- •Stage I-III breast cancer scheduled to undergo adjuvant or neoadjuvant paclitaxel-based chemotherapy for breast cancer using doxorubicin 60 mg/m² and cyclophosphamide 600 mg/m² followed by paclitaxel 80 mg/m² weekly for 12 weeks protocol code BRAJACTW [23].
- •Vitamin D insufficiency defined as serum level < 30 ng/ml.
- •Ability to give informed consent as per the legal requirement.
排除标准
- •Prior neurotoxic chemotherapy including paclitaxel.
- •Metastatic carcinoma.
- •History of any other malignancy except malignancy that was treated with curative intent and for which there has been no known active disease for more than 3 years prior to randomization, curatively treated non-melanoma skin malignancy, cervical cancer in situ, in situ ductal carcinoma, or breast in situ lobular carcinoma.
- •Grade II neuropathy or higher based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.
- •neurosensory or neuromotor neuropathy, regardless of causality.
- •Patients who are scheduled to receive any neurotoxic chemotherapeutic agents such as platinum compounds (carboplatin, cisplatin), vinorelbine, eribulin, and ixabepilone.
- •Diabetes mellitus
- •Psychiatric disorders that limit ability to comply with study protocol i.e., history of regular exacerbation of major psychosis (schizophrenia, bipolar disorder) in last 2 years.
- •Known Fibromyalgia
- •Gastric bypass surgery.
- •Patients with chronic granuloma forming disorders (sarcoidosis or tuberculosis TB).
- •Known hyperparathyroidism.
- •Known thyroid dysfunction.
- •Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
- •Pregnancy and lactation.
- •Hypercalcemia (corrected blood calcium > 10.5 mg/dl or > 2.6 mmol/L)[24]
- •Hyperphosphatemia, serum phosphate concentration > 4.5 mg/dL [25]
- •History of symptomatic genitourinary stones within the past year.
- •Allergy to any cholecalciferol dosage form component.
- •Alcohol consumption.
- •Regular use of vitamin D > 2000 IU daily over the past year.
- •Inability to swallow pills.
- •Medications that may interfere with vitamin D metabolism, including enzyme inducing anticonvulsants, lithium, phenytoin, verapamil, orlistat, tuberculosis medications as isoniazid, and/or rifampin and estrogen-containing medications.
- •Patients receiving any of the following medications used to prevent CIPN: vitamin E, glutamine, nortriptyline, amitriptyline, tricyclic antidepressants, pregabalin, and duloxetine and other nutritional supplements as vitamin B during taxane administration.
研究组 & 干预措施
Intervention group
In conjunction with the AC-T chemotherapy protocol, individuals in the intervention group who have a vitamin D deficiency will receive vitamin D replacement therapy.
干预措施: Vitamin D (Cholecalciferol ) (Drug)
结局指标
主要结局
The cumulative incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)
时间窗: PIPN will be assessed throughout the 12-weeks paclitaxel administration phase.
The incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN) will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
次要结局
- The modified total neuropathy score mTNS.(The change in mTNS will be compared at weeks 18 and 24 relative to baseline.)
- EORTC QLQ-CIPN20(Taxane-induced peripheral neuropathy using (EORTC QLQ-CIPN20) at weeks 13, 15,18, 21 and 24.)
- Quality of life(Quality of life (QOL) assessed at the first week, then at weeks 13 and 24.)
研究者
Abdelrahman Mahmoud
Dr
Cairo University