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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lucia Gafner, Dr. sc. nat.
- Numer telefonu: +41 52 266 21 37
- E-mail: lucia.gafner@ksw.ch
Kopia zapasowa kontaktu do badania
- Nazwa: Esther Gerrits, Dr. med.
- Numer telefonu: +41 52 266 38 10
- E-mail: esther.gerrits@ksw.ch
Lokalizacje studiów
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Winterthur, Szwajcaria, 8401
- Kantonsspital Winterthur
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Kontrola
Opieka standardowa.
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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Quality of Life (QoL)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Stan odżywienia
Ramy czasowe: 3 miesiące
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Analiza impedancji bioelektrycznej (BIA)
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3 miesiące
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Stan odżywienia
Ramy czasowe: 3 miesiące
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Masa mięśniowa: obraz L3 z pomiarów tomografii komputerowej (CT) wykonanych w kontekście standardowej terapii przeciwnowotworowej (podzielony przez wzrost do kwadratu; w cm2/m2)
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3 miesiące
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Dane kliniczne
Ramy czasowe: 3 miesiące
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Stan sprawności fizycznej (stan sprawności WHO, stopień 0-5)
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3 miesiące
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Nutritional status
Ramy czasowe: 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
Ramy czasowe: 3 months
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Calf circumference (cm)
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3 months
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Physical function
Ramy czasowe: 3 months
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Handgrip strength
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3 months
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Physical function
Ramy czasowe: 3 months
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60-second sit-to-stand test
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3 months
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Physical function
Ramy czasowe: 3 months
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6-minute walk test
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3 months
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Energy- and protein intake
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 3 months
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Overall survival
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3 months
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Clinical data
Ramy czasowe: 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
Ramy czasowe: 3 months
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Serious adverse events (SAEs; unplanned hospitalizations)
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3 months
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Clinical data
Ramy czasowe: 3 months
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Progression free survival
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3 months
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Fatigue
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Christian Britschgi, PD Dr. med. Dr. phil., Kantonsspital Winterthur KSW
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-00199
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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