The Effect of Channa Striata and Curcuma Supplementation on Nutritional Status, Interleukin-6 Levels, and Quality of Life in Patients With Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Nutritional status
研究概览
简要总结
Breast cancer is frequently accompanied by chronic inflammation, malnutrition, and reduced quality of life, all of which may compromise treatment response and clinical outcomes. Nutritional interventions with immunomodulatory and anti-inflammatory properties have the potential to improve these conditions. Channa striata is rich in high-quality protein, albumin, and essential amino acids that support nutritional recovery and tissue repair, while Curcuma contains curcumin, a bioactive compound with well-established anti-inflammatory and antioxidant effects. This study aims to evaluate the effect of combined Channa striata and Curcuma supplementation on nutritional status, serum interleukin-6 (IL-6) levels, and quality of life in patients with breast cancer undergoing treatment. The findings are expected to provide evidence for the use of this nutritional supplementation as a complementary strategy to improve clinical outcomes, reduce systemic inflammation, and enhance the overall well-being of breast cancer patients.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with breast cancer aged ≥18 years who were undergoing chemotherapy.
- •Patients with a body mass index (BMI) of 18-29 kg/m².
- •Patients currently receiving chemotherapy for breast cancer.
- •Patients with serum albumin levels of 2.0-3.5 g/dL.
- •Patients who were able to consume oral food and were willing to participate in the study by providing written informed consent.
排除标准
- •Patients with chronic kidney disease, renal failure, or kidney infection.
- •Patients with a known allergy to fish or Channa striata (snakehead fish) albumin-derived products.
- •Patients receiving other protein or amino acid supplements during the study period.
- •Patients who were non-compliant or discontinued the intervention before completion of the study.
研究组 & 干预措施
experimental : channa striata and curcuma
intervention group
干预措施: channa striata and curcuma (Dietary Supplement)
control
control group
干预措施: Maltodextrin (Placebo) (Dietary Supplement)
结局指标
主要结局
Nutritional status
时间窗: baseline post intervention 4 weeks
This study evaluated changes in BMI, following one month of Channa striata and Curcuma supplementation.
次要结局
- interleukin - 6(Baseline and 1 month after intervention)
研究者
DINA KEUMALA SARI
Prof
Universitas Sumatera Utara