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临床试验/CTRI/2024/10/076040
CTRI/2024/10/076040招募中2 期

Nutritional intervention of raisins, dates, and figs for chemotherapy-induced anemia (Pandu) in breast cancer patients

Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre Wagholi Pune1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Hemoglobin, Total WBC, Differential Leucocyte count, RBC Indices, Platelet indices, Erythrocyte Sedimentation rate; Iron specific: Serum iron, Serum ferritin, Transferrin level or Total Iron Binding Capacity; LFT: Sr. Bil., SGPT, SGOT, KFT: Sr. Creatinine, BUN and BSL (Random)

研究概览

简要总结

This is a randomized, single blind, controlled clinical study, to assess the effects of nutritional intervention of black raisins, figs and dates in breast cancer female patients undergoing first line chemotherapy for a period of 6 months. The primary objective is to assess hematological; iron specific status as Serum iron, Serum ferritin, Transferrin level or Total Iron Binding Capacity; liver functions and Kidney functions. The secondary outcomes will include Ayurvedic symptom assessment, FACIT- Fatigue Scale, FACT-AN Scale, Quality of Life assessed by core module C-30 and BR-45 breast cancer questionnaires, Karnofsky’s Performance Score, and weight at all times points.

Both groups will be taking chemotherapy and allied drugs such as Filgrastim (as and when required) during chemotherapy as prescribed by the oncologist. There will be no deviation from the standard line of treatment in both groups. Those patients exhibiting hemoglobin levels below 8 mg/dl will be advised to undergo blood transfusion as prescribed by the oncologist for continuation of chemotherapy. The intervention under this proposed study will be completed as per the study design and all significant events will be noted carefully for further assessment.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • Female Breast Cancer patients up to Stage III, undergoing first-line chemotherapy with or without hormonal and radiotherapy treatment.

排除标准

  • Male breast cancer patients, Breast Cancer patients scheduled for second-line chemotherapy, Planned for neoadjuvant chemotherapy, Post- blood transfusion before starting the chemotherapy, Patients taking iron supplements.

结局指标

主要结局

Hemoglobin, Total WBC, Differential Leucocyte count, RBC Indices, Platelet indices, Erythrocyte Sedimentation rate; Iron specific: Serum iron, Serum ferritin, Transferrin level or Total Iron Binding Capacity; LFT: Sr. Bil., SGPT, SGOT, KFT: Sr. Creatinine, BUN and BSL (Random)

时间窗: A- 0 week as Baseline - before starting chemotherapy | B- 12 weeks as Mid-chemotherapy | C - 24 weeks at the end of chemotherapy

次要结局

  • 1. Assessment of Ayurvedic symptoms of Pandu viz., Panduta, Rukshata, Agnimandya, Aruchi, Shaithilya, Hrudrava(2. FACIT- Fatigue Scale)

研究者

发起方
Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre Wagholi Pune
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sandeep Bhagwan Chavan

Bharatiya Sanskriti Darshan Trusts Integrated Cancer Treatment and Research Centre

研究点 (1)

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