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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Lucia Gafner, Dr. sc. nat.
- 電話番号：+41 52 266 21 37
- メール：lucia.gafner@ksw.ch
研究連絡先のバックアップ
- 名前：Esther Gerrits, Dr. med.
- 電話番号：+41 52 266 38 10
- メール：esther.gerrits@ksw.ch
研究場所
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Winterthur、スイス、8401
- Kantonsspital Winterthur
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：コントロール
スタンダードケア。
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of Life (QoL)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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栄養状態
時間枠：3ヶ月
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生体電気インピーダンス分析 (BIA)
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3ヶ月
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栄養状態
時間枠：3ヶ月
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筋肉量: 標準的ながん治療の状況で撮影されたコンピューター断層撮影 (CT) 測定の L3 画像 (身長の 2 乗で割った; cm2/m2 単位)
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3ヶ月
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臨床データ
時間枠：3ヶ月
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身体パフォーマンスステータス (WHO パフォーマンスステータス、グレード 0 ～ 5)
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3ヶ月
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Nutritional status
時間枠：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
時間枠：3 months
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Calf circumference (cm)
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3 months
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Physical function
時間枠：3 months
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Handgrip strength
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3 months
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Physical function
時間枠：3 months
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60-second sit-to-stand test
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3 months
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Physical function
時間枠：3 months
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6-minute walk test
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3 months
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Energy- and protein intake
時間枠：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
時間枠：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
時間枠：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
時間枠：3 months
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Overall survival
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3 months
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Clinical data
時間枠：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
時間枠：3 months
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Serious adverse events (SAEs; unplanned hospitalizations)
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3 months
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Clinical data
時間枠：3 months
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Progression free survival
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3 months
|
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Fatigue
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
協力者
捜査官
- 主任研究者：Christian Britschgi, PD Dr. med. Dr. phil.、Kantonsspital Winterthur KSW
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-00199
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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