A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors (SwissNutriAct2)
A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Randomized Controlled Intervention Trial in Patients With Advanced Tumors
Cancer patients have a higher risk of malnutrition because of their illness and treatments. This can lead to weight loss, weak muscles, less effective cancer therapy, or stronger side effects.
This research project looks at whether adding a combined nutrition and exercise program to the standard treatment for appetite loss (olanzapine) can improve the quality of life for patients with cancer, compared to taking olanzapine alone.
In this study, patients are randomly split into two groups. The program group gets advice from nutrition experts and physiotherapists. They also receive a nutritional supplement containing whey protein, leucine, and HMB (substances that help protect muscles). The control group continues their usual cancer treatment without the extra nutrition and exercise program. Both groups receive olanzapine as part of their standard care to treat loss of appetite, and both keep a diary to track their progress.
Information will be collected at the start of the study, as well as after 6, 12, and 24 weeks.
Nutritional advice and exercise are safe, easy-to-use steps that can help patients with cancer, especially when done together.
研究概览
地位
详细说明
Cancer-related malnutrition represents a major clinical challenge. It is characterized by involuntary weight loss, muscle wasting, functional decline, reduced quality of life (QoL), longer and more frequent hospitalizations, and an increased risk for complications. Together, these factors substantially increase healthcare costs.
Despite growing awareness, evidence from robust randomized trials on multimodal interventions remains limited. Effective management requires a coordinated, multidisciplinary, and multimodal strategy.
The combination of nutritional counseling, physical exercise, and olanzapine (an ASCO-recommended appetite stimulant used according to standard care) may synergistically improve QoL (primary endpoint; Functional Assessment of Cancer Therapy - General; FACT-G), as well as nutritional status, energy intake, fatigue, muscle mass, and strength (secondary endpoints) in patients with advanced cancer.
With this prospective, randomized controlled trial, we aim to investigate whether adding a structured nutrition and exercise intervention to olanzapine improves QoL after 12 weeks of the program, compared to olanzapine alone.
Eligible outpatients with metastatic or locally advanced solid tumors and appetite loss will be randomized to either:
- an intervention group receiving personalized nutrition counseling and a physical exercise program, in combination with a leucine and β-hydroxy β-methylbutyrate (HMB)-enriched whey protein supplement; or
- a control group receiving standard oncological care.
All participants will receive low-dose olanzapine for the treatment of appetite loss according to standard clinical care, with treatment initiated after the baseline assessment at the start of the 12-week program.
Both arms will be assessed at baseline (0 weeks), after the 12-week intervention phase, and at a follow-up assessment after 24 weeks.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Lucia Gafner, Dr. sc. nat.
- 电话号码：+41 52 266 21 37
- 邮箱：lucia.gafner@ksw.ch
研究联系人备份
- 姓名：Esther Gerrits, Dr. med.
- 电话号码：+41 52 266 38 10
- 邮箱：esther.gerrits@ksw.ch
学习地点
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Winterthur、瑞士、8401
- Kantonsspital Winterthur
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥18 years
- Metastatic or locally advanced solid tumors, excluding lymphoma, not eligible for curative treatment
- VAS score ≤70 for appetite, as defined for anorexia in oncology patients (olanzapine is prescribed according to clinical guidelines as part of standard care)
- WHO-PS of ≤3
- Ability to participate in physical exercise, as judged by the treating oncologist
- Anticipated life expectancy of at least six months
- Willingness to provide written informed consent
Exclusion Criteria:
- Pregnancy or breastfeeding
- Parkinson's disease, known risk for narrow-angle glaucoma, or any other contraindication to olanzapine, as judged by the treating oncologist
- Alcohol consumption >2 units/d
- Use of Olanzapine for any indication for more than four days per month
- Current use of any antipsychotic or antidepressant medication
- Recent use of systemic corticosteroids (prednisolone ≥10 mg/d or equivalent) for more than seven days within the past four weeks
- Presence of ascites at time of enrolment
- Concurrent radiotherapy to the esophagus
- Intake of products with added high-dose BCAA (branched-chain amino acids, total ≥3 g/d) within the past month
- Tube feeding and/or parenteral nutrition within the previous month (excluding ONS (oral nutritional supplements)
- History of ileus within the past month
- Allergy to milk protein
- Inability to comprehend trial information due to language barriers, cognitive or psychological limitations, or disease-related factors
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：控制
标准护理。
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实验性的：Intervention
Nutrition and exercise program including a nutritional supplement.
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The nutritional intervention includes a comprehensive 45-60 minute initial assessment with the study dietitian and personalized dietary recommendations and individualized interventions.
Counseling comprises at least three sessions.
During follow-up visits, nutritional status is reassessed and interventions are adapted as needed.
The structured exercise program includes at least three visits with the study physiotherapist, starting with a comprehensive 45-60 minute initial assessment.
The training regimen is re-evaluated at least twice.
The program emphasizes home-based strength and endurance training, aiming to meet or exceed the guidelines of the WHO and the American Cancer Society: 2.5 hours of moderate- or 1.25 hours of high-intensity activity per week, or an equivalent combination thereof.
The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably in the evening or post-exercise.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Life (QoL)
大体时间：3 months
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Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G).
Total scores range from 0-108 points, with higher scores reflecting better QoL.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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营养状况
大体时间：3个月
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生物电阻抗分析 (BIA)
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3个月
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营养状况
大体时间：3个月
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肌肉质量：在标准癌症治疗的背景下进行的计算机断层扫描 (CT) 测量的 L3 图像（除以身高的平方；以 cm2/m2 为单位）
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3个月
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临床数据
大体时间：3个月
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体能状态（WHO 体能状态，0-5 级）
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3个月
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Nutritional status
大体时间：3 months.
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Body weight (in kg), used in combination with body height to calculate BMI (kg/m2)
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3 months.
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Nutritional status
大体时间：3 months
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Calf circumference (cm)
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3 months
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Physical function
大体时间：3 months
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Handgrip strength
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3 months
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Physical function
大体时间：3 months
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60-second sit-to-stand test
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3 months
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Physical function
大体时间：3 months
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6-minute walk test
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3 months
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Energy- and protein intake
大体时间：3 months
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Data collected with food diaries; Harris-Benedic formula
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3 months
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Adherence to the nutrition and exercise program
大体时间：3 months
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Completed counseling sessions; supplement intake; adherence based on data recorded in the journal
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3 months
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Succes of recruitment rate in comparison to former studies
大体时间：Throughout recruitment phase.
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Number of eligible patients, participants, rejections as compared to similar past studies
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Throughout recruitment phase.
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Clinical data
大体时间：3 months
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Overall survival
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3 months
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Clinical data
大体时间：3 months
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Adverse events (AEs) grade 3 and 4
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3 months
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Clinical data
大体时间：3 months
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Serious adverse events (SAEs; unplanned hospitalizations)
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3 months
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Clinical data
大体时间：3 months
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Progression free survival
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3 months
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Fatigue
大体时间：3 months
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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue).
Total scores range from 0-52 points, with higher scores reflecting less pronounced fatigue.
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3 months
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Nutritional status
大体时间：3 months
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Sarcopenia questionnaire: sarcopenia functional assessment (SARC-F).
Total scores range from 0-10 points, with higher scores reflecting higher sarcopenia risk.
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3 months
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Nutritional status
大体时间：3 months
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Global Leadership Initiative of Malnutrition (GLIM) criteria, a diagnositic tool for malnutrition, focusing on phenotypic and etiologic criteria.
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3 months
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Appetite
大体时间：3 months
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Visucal analog scale (VAS) for appetite.
Total scores range from 0-100, with higher scores reflecting better Appetite.
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3 months
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Appetite
大体时间：3 months
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Anorexia-cachexia scale (A/CS).
Total scores range from 0-48 points, with higher scores reflecting better Appetite.
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3 months
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Nutritional status
大体时间：3 months
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Patient-generated subjective global assessment, short form, PG-SGA SF.
Total scores range from 0-36 points, with lower scores reflecting better nutritional status.
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3 months
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合作者和调查者
合作者
调查人员
- 首席研究员：Christian Britschgi, PD Dr. med. Dr. phil.、Kantonsspital Winterthur KSW
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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