The Effect of Vitamin D on Factors Contributing Pre Cachexia and Cachexia, a Study on Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8
研究概览
简要总结
Several ex vivo, in vitro, and observational studies on various type of cancer shown positive effect of vitamin D. Vitamin D has widely known as immunomodulator property in various diseases. However, it remains limited studies on immunity and cachexia in cancer, particularly in ovarian cancer. This study will investigate the effect of vitamin D in immune response during chemotherapy among epithelial ovarian cancer patients who have a low level of vitamin D and cachexia
详细描述
Studies result from laboratory suggested that vitamin D inhibit cancer cell proliferation and upregulate apoptosis pathway. Data from observational and ecology studies showed the inverse relationship between level of vitamin D and cancer risk. Clinical trials on colorectal, prostate, and breast cancer suggested that vitamin D had positive effect and improved clinical markers.
Vitamin D may alter immune response through regulation on cytotoxic CD8 T-lymphocyte and reduce pro inflammatory cytokines. High level of interleukin-6 and other cytokines in cancer may decrease lymphocyte T activity, resulting lowering effect of immune response.
This clinical trial will enroll 54 adults with newly diagnosed epithelial ovarian cancer patients. Following receive of informed consent, they will randomly allocated to receive whether vitamin D 2000 IU or placebo during chemotherapy period (6 cycles).
Subjects will fill out questionnaire on their first visit as well as each chemotherapy cycle (each month). Questionnaire will ask about demographic data, meal intake, sun exposure, and cachexia questionnaire (based on Cachexia Score). Subjects will also be examined on their physical status, anthropometry (weight, height, waist circumference), as well as body composition (fat mass, fat free mass, fat free mass index, phase angle).
Blood samples will be drawn from peripheral vein and sent to National Cancer Referral Hospital laboratory to measure 25(OH)D level, interleukin-6, CD8 cytotoxic level, CD8 cytotoxic activity, and circulating tumor cells. Blood collection will be done on the first visit, 3rd cycle of chemotherapy, and last cycle of chemotherapy. Subjects will be given their samples result during follow-up visit.
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
- Double (Participant, Investigator)
盲法说明
Neither do investigator nor participants will not know the random allocation
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-60 years old who are newly diagnosed with ovarian cancer based on histopathology
- •epithelial ovarian cancer stage II-III
- •haven't received chemotherapy
- •pre-cachexia or cachexia
- •level of vitamin D below 30 ng/ml
- •no vitamin D allergy
- •ability and willingness to understand and provide informed consent
排除标准
- •autoimmune disease
- •chronic liver disease
- •chronic renal disease
- •known had hypercalcemia
- •refractory cachexia
结局指标
主要结局
Rate of immune response in participants receiving vitamin D change from baseline as assessed by lymphocyte CD8
时间窗: 6 months
lymphocyte CD8 is measured by flowcytometry
次要结局
- Find the change of vitamin D level(6 month)
- Find the rate of sun exposure(1 week)
- Find the daily intake of vitamin D from food(1 month)
- Effect of vitamin D in lowering inflammation(6 months)
- Effect of vitamin D in lowering circulation tumor cells (CTC)(6 months)
- Effect of vitamin D in improving staging of cachexia(6 month)
研究者
dr. Nurul Ratna Mutu Manikam, M.Gizi., Sp.GK
Principle Investigator
Indonesia University