A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Randomized Controlled Intervention Trial in Patients With Advanced Tumors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Quality of Life (QoL)
研究概览
简要总结
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.
详细描述
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:
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Nutrition and exercise program including a nutritional supplement.
干预措施: Standardized nutritional program (Behavioral)
Intervention
Nutrition and exercise program including a nutritional supplement.
干预措施: standardized exercize program (Behavioral)
Intervention
Nutrition and exercise program including a nutritional supplement.
干预措施: Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB) (Dietary Supplement)
Control
Standard care.
结局指标
主要结局
Quality of Life (QoL)
时间窗: 3 months
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G). Total scores range from 0-108 points, with higher scores reflecting better QoL.
次要结局
- Nutritional status(3 months.)
- Nutritional status(3 months)
- Physical function(3 months)
- Energy- and protein intake(3 months)
- Adherence to the nutrition and exercise program(3 months)
- Succes of recruitment rate in comparison to former studies(Throughout recruitment phase.)
- Clinical data(3 months)
- Fatigue(3 months)
- Appetite(3 months)