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临床试验/CTRI/2025/12/099374
CTRI/2025/12/099374招募中不适用

Comparing nutrient intake and quality of life in adults undergoing treatment for solid tumors, given either an oral nutritional protein supplement with dietary counselling or receiving dietary counselling alone (ProtiMedic- Onco).

Dutch Medical Food India Private Limited1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年2月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
126
试验地点
1

研究概览

简要总结

Malnutrition is a common and significant concern among patients undergoing chemotherapy for solid tumors, particularly breast and lung cancer, and can adversely affect treatment tolerance, functional capacity, and quality of life. Regular assessment of nutritional status, including body weight, body mass index (BMI), and dietary intake, is essential for early identification and management of nutritional deficiencies. This study aims to explore and inform appropriate nutritional intervention strategies to improve the nutritional status, functional capacity, and quality of life of patients with solid tumors receiving chemotherapy. The primary objective of this study is to compare the effects of an oral nutritional protein supplement administered along with dietary counselling versus dietary counselling alone on protein intake. Secondary objectives include comparison of energy intake, total calorie intake, serum total protein levels, serum albumin to globulin (A/G) ratio, changes in body weight and BMI, hand grip strength assessed using a dynamometer, quality of life, and treatment-related toxicities. Energy and protein intake will be assessed at baseline and at weeks 4, 8, and 12 using a food diary provided by the study team. Blood samples collected at baseline and at the end of the study will be used to assess biochemical nutritional parameters, including serum protein and albumin–globulin ratio. Quality of life will be evaluated at baseline and during follow-up visits using validated questionnaires. Compliance will be assessed based on the proportion of the prescribed nutritional supplement consumed. Safety will be monitored at baseline and at each study visit until the end of the study through clinical assessments and documentation of adverse events.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
50.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Subjects with diagnosed solid tumors (stage 2 and stage 3)
  • Adults of both gender over 50 years with disease-related malnourished adults who undergo chemotherapy for solid tumor indications
  • Medium to a high degree of malnourishment, according to MUST criteria.
  • The subject must be able to eat and drink.
  • The subject must be ambulatory
  • The subject must be able to provide informed consent.

排除标准

  • Subjects hospitalized for acute conditions impacting their metabolism.
  • Subjects with prostate cancer, leukemia, Blood cancer lymphoma, and recurrence.
  • Subjects with known allergies to Milk and Collagen
  • Subjects with chronic kidney disease requiring dialysis.
  • Subjects taking other forms of nutritional support.
  • Subjects with dysphagia, malabsorption or related GI disorders, poorly controlled diabetes, or liver failure, extreme malnutrition or anorexia.
  • Subjects with any disease state resulting in abnormal (high) A/G ratio.
  • Subjects receiving end-of-life care.
  • Subjects who are unable to provide informed consent.
  • Critically ill cancer patients.

研究者

发起方
Dutch Medical Food India Private Limited
申办方类型
Other [neutraceuticals]
责任方
Principal Investigator
主要研究者

Dr Sankar Srinivasan

Apollo Speciality Hospitals

研究点 (1)

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