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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Lucia Gafner, Dr. sc. nat.
- 전화번호: +41 52 266 21 37
- 이메일: lucia.gafner@ksw.ch
연구 연락처 백업
- 이름: Esther Gerrits, Dr. med.
- 전화번호: +41 52 266 38 10
- 이메일: esther.gerrits@ksw.ch
연구 장소
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Winterthur, 스위스, 8401
- Kantonsspital Winterthur
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
표준 관리.
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quality of Life (QoL)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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영양 상태
기간: 3 개월
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생체 전기 임피던스 분석(BIA)
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3 개월
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영양 상태
기간: 3 개월
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근육량: 표준 암 치료와 관련하여 촬영한 컴퓨터단층촬영(CT) 측정치의 L3 이미지(높이 제곱으로 나누기, cm2/m2)
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3 개월
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임상 데이터
기간: 3 개월
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신체 수행 상태(WHO 수행 상태, 0-5등급)
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3 개월
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Nutritional status
기간: 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
기간: 3 months
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Calf circumference (cm)
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3 months
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Physical function
기간: 3 months
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Handgrip strength
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3 months
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Physical function
기간: 3 months
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60-second sit-to-stand test
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3 months
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Physical function
기간: 3 months
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6-minute walk test
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3 months
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Energy- and protein intake
기간: 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
기간: 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
기간: 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
기간: 3 months
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Overall survival
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3 months
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Clinical data
기간: 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
기간: 3 months
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Serious adverse events (SAEs; unplanned hospitalizations)
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3 months
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Clinical data
기간: 3 months
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Progression free survival
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3 months
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Fatigue
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Christian Britschgi, PD Dr. med. Dr. phil., Kantonsspital Winterthur KSW
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-00199
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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