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临床试验/NCT07613125
NCT07613125进行中(未招募)不适用

The Effect of Nutritional Supplementation Consisting Locally Available Food Along With Micronutrients to Improve Cancer Cachexia in Bangladesh: A Quasi-experimental Study.

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
106
试验地点
1

研究概览

简要总结

Background (brief): Burden: Cancer is the sixth leading cause of death in Bangladesh, posing a significant public health challenge. Among the major complications associated with cancer, cachexia remains a critical concern. Cancer cachexia is a multifactorial syndrome characterized by severe and progressive weight loss, muscle wasting, and metabolic dysfunction, significantly impacting patient's overall health. It not only leads to a decline in quality of life but also contributes to poor treatment outcomes and reduced overall survival. Despite its profound clinical implications, effective therapeutic strategies for managing cancer cachexia remain limited. Addressing this condition is essential for improving the prognosis and well-being of cancer patients, highlighting the urgent need for further research and targeted interventions.

Knowledge gap: It has been reported that a single nutritional supplement alone is not enough to combat cancer related cachexia. Many commercial formulas are available in the market, but these are costly and out of reach for the people of low- and middle-income countries.

Hypothesis (if any): Egg-enriched rice starch water fortified with multivitamins and multimineral is efficient in managing cancer cachexia.

Objectives: Our primary objective is to observe the effects of locally developed nutritional supplement on cancer cachexia.

Methods: This will be a prospective study with quasi-experimental design to be conducted among the patients with cancer cachexia admitted to a tertiary hospital. Patients will be recruited from the department of surgical oncology, National Institute of Cancer Research & Hospital (NICRH). Patients in intervention group will receive cooked rice starch water mixed with egg and multivitamin multimineral pre-mix for 14 days, in addition to conventional treatments for cancer. The control group will receive the conventional diet provided from hospital.

Outcome measures/variables:

Primary: Improvement in serum albumin and haemoglobin after nutritional supplementation Secondary: Change in quality of life, change is basal metabolic index (BMI)

详细描述

Cancer is one of the major societal, public health, and economic problems of the 21st century. It encompasses a diverse group of diseases characterized by uncontrolled proliferation of abnormal cells, which can invade surrounding tissues and metastasize to distant organs. Despite advances in diagnostic modalities and therapeutic interventions, the burden of cancer continues to rise, particularly in low- and middle-income countries (LMICs). The global burden of cancer presents a formidable challenge to public health in the 21st century. According to the International Agency for Research on Cancer, the world witnessed approximately 20 million new cancer cases and 9.7 million deaths attributed to cancer in 2022 . In the South-East Asia region cancer also poses a significant public health challenge. In 2022, World Health Organization (WHO) reported approximately 2.37 million new cancer cases and 1.53 million deaths attributed to the disease in the South-East Asia region. Moreover, the burden of cancer is projected to rise, with an increase of new cases by 85.7% by 2050. According to estimates from the World Health Organization (WHO), the leading causes of cancer-related mortality worldwide in 2020 were lung cancer (1.80 million deaths), followed by colorectal cancer (916,000 deaths), liver cancer (830,000 deaths), stomach cancer (769,000 deaths), and breast cancer (685,000 deaths). Solid tumors accounts for approximately 90% of adult human cancer. Surgery is often the primary treatment for solid tumors, especially in early stages. It is estimated that by 2030 annually 45 million surgical procedures will be needed worldwide.

With a population of 171.2 million, Bangladesh is the world's eighth most populous country. The Global Cancer Observatory reported 156,775 new cancer cases and 108,990 cancer-related deaths occurred in Bangladesh in 2020. The age-standardized rates of 106.2 and 75.3 per 100,000 for cancer incidence and mortality, respectively.

As cancer prevalence increases, so does the incidence of cancer-associated complications, among which cancer cachexia is one of the most significant.

Cancer cachexia is a multifactorial syndrome characterized by progressive weight loss, skeletal muscle wasting and metabolic dysregulation in patients with cancer. It has been reported that conventional nutritional supplementation alone is not enough to combat cancer cachexia. Recent research has highlighted the potential role of specialized nutritional strategies in mitigating the impact of cancer cachexia. A positive protein balance is required to increase skeletal muscle mass. A recent study showed that patients with low serum albumin level had markedly poorer prognosis than those in the high serum marker group. Consistent with this, the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines recommend a daily protein intake should be 1.0-1.5 gm/kg. In terms of multivitamin, vitamin B complex plays a crucial role in managing cancer cachexia. Vitamin B particularly B3 (niacin), B6, and B12, are essential cofactors for various enzymes involved in energy production and metabolism. Studies showed that decreased levels of B vitamin-related enzymes in the liver, along with alterations in one-carbon metabolism, are hallmarks of cancer cachexia.

The National Institute of Cancer Research & Hospital (NICRH) is a 500-bed tertiary specialized located in Dhaka, Bangladesh. NICRH is the only government hospital, dedicated to comprehensive cancer care, education, and research. They offer a comprehensive range of specialties including surgical oncology, radiation oncology, medical oncology, cytopathology, histopathology. The department of surgical oncology provides surgical interventions for various cancers. Surgical patients typically stay in the hospital for 15 to 20 days. These patients often present after prolonged periods of inadequate nutritional intake, frequently with hypoalbuminemia. In the context of limited access to advanced nutritional support, many patients at NICRH infrequently consume rice water mixed with egg as a locally available nutritional supplement. This low-cost locally developed nutritional formula improve energy intake and protein status. Rice starch water is culturally accepted, low cost, easily digestible source of complex carbohydrate. Unlike milk, rice-based water avoids lactose intolerance and is less likely to provoke nausea/vomiting. It also provides hydration and a slow-release energy source critical for cachectic patients with poor appetite. Moreover, the effectiveness of this combination remains uncertain, particularly in terms of essential micronutrients. The purpose of this study is to analyse the role of evidence-based nutritional interventions in cancer cachexia with an affordable cost.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age- ≥18 years.
  • Diagnosed case of cancer who met Fearon et al's criteria for cancer cachexia.
  • Informed written consent.

排除标准

  • Patients with severe organ dysfunction, such as: renal failure (chronic kidney disease stage 4 and above), advanced hepatic failure (child-pugh score class B or C), severe cardiac dysfunction (heart failure, arrythmia, acute coronary syndrome).
  • Patient with stage 4 (metastasis) cancer
  • Patients with active gastrointestinal obstruction or any complication that will interfere with oral and tube feeding.
  • Patient who are already getting commercially available nutritional formula or multivitamin, multimineral therapy.
  • Patients with a recent history (e.g., <3 months) of participation in another nutritional intervention study.
  • Patients who require exclusive parenteral feeding.
  • Patients with a known allergy to egg protein

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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