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临床试验/CTRI/2026/02/103522
CTRI/2026/02/103522尚未招募1 期

Feasibility of high fibre dietary intervention in newly diagnosed Multiple Myeloma patients and its effect on gut microbiome and disease remission.

Amala Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月18日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
40
试验地点
1

研究概览

简要总结

Multiple myeloma is a common hematological malignancy that is usually treated with chemotherapy and immunomodulatory drugs such as Lenalidomide. In India, patients and their families often attempt dietary modification after a cancer diagnosis, influenced by traditional practices including Ayurveda. However, typical Indian diets, although predominantly plant-based, frequently do not provide adequate dietary fibre, which is important for maintaining a healthy gut microbiome. The human gut microbiome plays a crucial role in immune regulation and cancer treatment response, and its composition can be modulated by dietary intake; high-fibre diets modulate the gut microbiome, increasing the abundance of butyrate-producing bacterial species, which have anti-inflammatory and immunomodulatory effects and are associated with improved outcomes, including minimal residual disease (MRD) negativity in multiple myeloma.

This study aims to assess the feasibility of a high fibre-rich diet during initial treatment of multiple myeloma and to determine whether the intervention is tolerable and influences response to standard induction chemotherapy. Patients receiving standard induction therapy with Lenalidomide, Bortezomib, and Dexamethasone will follow a high-fibre, plant-based diet using locally available foods, and the impact of this intervention on the gut microbiome will be assessed through stool samples collected at baseline and at the end of induction therapy. Patient gastrointestinal symptoms, dietary adherence, and clinical response will be assessed at baseline and at the end of induction therapy to evaluate both the tolerability of the diet and its potential influence on treatment outcomes.If the high-fibre dietary intervention is feasible and well tolerated, it will be further evaluated in combination with chemotherapy in future phase II and phase III clinical trials to assess its potential impact on gut microbiome modulation and treatment outcomes.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed Multiple Myeloma patients Aged 18 to 60 years Who will be treated with Lenalidomide/Bortezomib/Dexamethasone induction [VLD] chemotherapy.

排除标准

  • Relapsed Multiple Myeloma Patient with inflammatory bowel disease or other contraindications for a high-fibre diet Multiple Myeloma with renal failure at diagnosis.

研究者

申办方类型
Other [Charitable Trust]
责任方
Principal Investigator
主要研究者

Dr Krishna K Yathi

Amala Institute of Medical sciences

研究点 (1)

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