Efficacy of medicinal plant based nutritional formulation as an adjuvant in gastrointestinal cancer therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Alleviation of NIS (PG-SGA tool) and improvement in nutritional status (PG-SGA tool) and quality of life (EORTC tool).
研究概览
简要总结
Thisis a randomized, open label, nutrition intervention study to evaluate theefficacy of a high energy high protein food formulation enriched with Annona reticulata aqueous leaves extractin the management of gastrointestinal cancers in patients undergoingchemotherapy and/or radiotherapy. Primary outcome expected is alleviation ofNIS, improvement in nutritional status and quality of life. The foodformulation is composed of Wheat, Rice, Ragi, Bengal gram, Green gram, Wheyprotein concentrate, Encapsulated maltodextrin containing the extract, Coconutoil and Palm oil. Each patient will receive 100g of foodformulation per day during the study period.
Parameterssuch as body composition, somatic, biochemical, dietary, antioxidant status andquality of life will be evaluated at baseline, during intervention (4thweek) and after intervention (8th week) to evaluate the efficacy ofthe food formulation in the management of gastrointestinal cancer.
Note: 5 mL of blood will be drawn to analyze the haematologicaland biochemical parameters during the study period at three occasions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinician diagnosed subjects with histopathologically confirmed Gastrointestinal cancer of both the genders aged above 18years undergoing chemotherapy and/or radiotherapy.
排除标准
- •Subjects with terminal illness or other serious co-morbidities, pregnant women and the vulnerable group.
结局指标
主要结局
Alleviation of NIS (PG-SGA tool) and improvement in nutritional status (PG-SGA tool) and quality of life (EORTC tool).
时间窗: Baseline, 4th week and 8th week
次要结局
- Reduction in the inflammatory markers (CRP) and improvement in the antioxidant status (Serum) is expected.(Baseline, 4th week and 8th week)