A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors

Официальное название

A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Randomized Controlled Intervention Trial in Patients With Advanced Tumors

Обзор

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.

Подробное описание

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:

1. 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 2. 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.

Вмешательства

• Поведенческое Standardized nutritional program
  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.
• Поведенческое standardized exercize program
  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.
• Пищевая добавка Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)
  The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably in the evening or post-exercise.

Первичные конечные точки

• Quality of Life (QoL) [Срок оценки: 3 months]

Вторичные конечные точки (12)

• Fatigue [Срок оценки: 3 months]
• Nutritional status [Срок оценки: 3 months.]
• Nutritional status [Срок оценки: 3 months]
• Nutritional status [Срок оценки: 3 months]
• Nutritional status [Срок оценки: 3 months]
• Nutritional status [Срок оценки: 3 months]
• Nutritional status [Срок оценки: 3 months]
• Nutritional status [Срок оценки: 3 months]
• Physical function [Срок оценки: 3 months]
• Physical function [Срок оценки: 3 months]
• Physical function [Срок оценки: 3 months]
• Appetite [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• Kantonsspital Winterthur — Winterthur

Идентификаторы

NCT: NCT07722806 · 2026-00199

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗