NCT06311357Unknown不适用
Effects of Body Weight Change in the Medical Supplement Group in Patients With Early Breast Cancer During Chemotherapy: a Randomized, Controlled Trial
Department of Medical Services Ministry of Public Health of Thailand2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percent weight change
研究概览
简要总结
The goal of this RCT is to compare percent weight change in early breast cancer who takes medical supplement or not, during treatment with chemotherapy (standard AC regimen).
The main question is
• the change of weight (%) before and after complete treatment of breast cancer therapy.
Participants will be randomized into 2 group
- intervention group - receive medical supplement daily during chemotherapy treatment.
- control group - Nutritional advise during chemotherapy treatment.
详细描述
- The rational is to prove the hypothesis is that, the effect of medical supplement with nutritional advise can prevent the reduction of body weight, malnutrition and treatment complication, which eventually to improve of the quality of life.
- Primary endpoint of the study is to compare the effect of medical supplement on percent weight change in early breast cancer who received chemotherapy in Rajavithi hospital. Secondary endpoints are nutritional status (PG-SGA), quality of life.
- Sample size formula based on Bernard R. Fundamentals of biostatistics. 5th ed. Duxbery: Thomson learning; 2000. Enrollment of 40 patients.
- Randomization into 2 groups. Intervention arm : receive medical supplement daily (1 drink = 6 scoops in 250 ml water, 2 drinks/day) with nutritional advise. Control arm : nutritional advise only. Duration of treatment is 12 weeks
- Enrollment and data monitoring is assessed by the staffs of oncology department in Rajavithi hospital and the data will be recorded in computer based information system.
- Data assessment on week 0,6,12 during chemotherapy treatment.
- Data analyzed by descriptive statistics to characterize patients at entry. We did the efficacy analyses with intention to treat population
- We did analyses with R version 3.3.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Histopathological confirmed diagnosis of breast cancer
- •Breast cancer stage I-III
- •Recieve adjuvant or neoadjuvant doxorubicin and cyclophosphamide at Rajavithi hospital
- •LVEF >= 60% - ECOG score 0-1
排除标准
- •No indication for chemotherapy
- •Contraindication for chemotherapy
- •Breast cancer stage IV
- •Diabetic mellitus who requires insulin injection
- •BMI >= 30 kg/m2 or <= 16 kg/m2
- •Previously known other malignancies
- •Second primary cancer
- •Previously received chemotherapy or radiotherapy
- •Severe malnutrition with administration of TPN is indicated
- •Pregnancy or lactation
- •CKD stage 4-5
研究组 & 干预措施
Control
No Intervention
Nutritional advise
结局指标
主要结局
Percent weight change
时间窗: 12 weeks
The change of body weight (%) before and after chemotherapy treatment
次要结局
- EORTC QLQ-C30(12 weeks)
- Patient interpretation of the Patient-Generated Subjective Global Assessment(12 weeks)
- EORTC QLQ-BR23(12 weeks)
研究者
研究点 (2)
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