Cancer, Advanced Solid TumorsPhase 2SwissNutriAct2NCT07722806
A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors
A Phase 2 study testing Standardized nutritional program, standardized exercize program and Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB) in people with Cancer, Advanced Solid Tumors and Malnutrition, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer, Advanced Solid Tumors, Malnutrition
- What is being tested?
- Standardized nutritional program, standardized exercize program and Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Cancer, Advanced Solid Tumors, Malnutrition
- Being tested
- Standardized nutritional program, standardized exercize program, Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)
- Keywords
- Cancer, Palliative, Nutrition, Exercise, Quality of Life, Leucine, HMB, Olanzapine, Protein supplementation
- Medical subject headings
- Neoplasms, Malnutrition, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized nutritional programBehavioural
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.
standardized exercize programBehavioural
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.
Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)Dietary supplement
The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably in the evening or post-exercise.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care. |
| Intervention | Experimental | Nutrition and exercise program including a nutritional supplement. Receives: Behavioral: Standardized nutritional program; Behavioral: standardized exercize program; Dietary Supplement: Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (QoL)
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G). Total scores range from 0-108 points, with higher scores reflecting better QoL.
Measured: 3 months
Secondary outcomes (21)
Fatigue
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Total scores range from 0-52 points, with higher scores reflecting less pronounced fatigue.
Measured: 3 months
Nutritional status
Body weight (in kg), used in combination with body height to calculate BMI (kg/m2)
Measured: 3 months.
Nutritional status
Bioelectrical impedance analysis (BIA)
Measured: 3 months
Nutritional status
Muscle mass: L3 image of computertomographic (CT) measurements taken in the context of standard cancer therapy (divided by height squared; in cm2/m2)
Measured: 3 months
Nutritional status
Calf circumference (cm)
Measured: 3 months
Nutritional status
Sarcopenia questionnaire: sarcopenia functional assessment (SARC-F). Total scores range from 0-10 points, with higher scores reflecting higher sarcopenia risk.
Measured: 3 months
Nutritional status
Patient-generated subjective global assessment, short form, PG-SGA SF. Total scores range from 0-36 points, with lower scores reflecting better nutritional status.
Measured: 3 months
Nutritional status
Global Leadership Initiative of Malnutrition (GLIM) criteria, a diagnositic tool for malnutrition, focusing on phenotypic and etiologic criteria.
Measured: 3 months
Physical function
Handgrip strength
Measured: 3 months
Physical function
60-second sit-to-stand test
Measured: 3 months
Physical function
6-minute walk test
Measured: 3 months
Appetite
Visucal analog scale (VAS) for appetite. Total scores range from 0-100, with higher scores reflecting better Appetite.
Measured: 3 months
Appetite
Anorexia-cachexia scale (A/CS). Total scores range from 0-48 points, with higher scores reflecting better Appetite.
Measured: 3 months
Energy- and protein intake
Data collected with food diaries; Harris-Benedic formula
Measured: 3 months
Adherence to the nutrition and exercise program
Completed counseling sessions; supplement intake; adherence based on data recorded in the journal
Measured: 3 months
Succes of recruitment rate in comparison to former studies
Number of eligible patients, participants, rejections as compared to similar past studies
Measured: Throughout recruitment phase.
Clinical data
Physical performance status (WHO performance status, grade 0-5)
Measured: 3 months
Clinical data
Overall survival
Measured: 3 months
Clinical data
Adverse events (AEs) grade 3 and 4
Measured: 3 months
Clinical data
Serious adverse events (SAEs; unplanned hospitalizations)
Measured: 3 months
Clinical data
Progression free survival
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland, Sponser Sport Food AG, HOCH Health Ostschweiz, Kantonsspital St. Gallen
- Responsible party
- Sponsor
- Investigators
- Christian Britschgi, PD Dr. med. Dr. phil., Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722806
- Sponsor's protocol ID
- 2026-00199
- Acronym
- SwissNutriAct2
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Randomized Controlled Intervention Trial in Patients With Advanced Tumors
- ClinicalTrials.gov ID
- NCT07722806
- Acronym / sponsor ID
- SwissNutriAct2 / 2026-00199
- Conditions
- Cancer, Advanced Solid Tumors, Malnutrition
- Keywords
- Cancer, Palliative, Nutrition, Exercise, Quality of Life, Leucine, HMB, Olanzapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Collaborators
- Krebsforschung Schweiz, Bern, Switzerland, Sponser Sport Food AG, HOCH Health Ostschweiz, Kantonsspital St. Gallen
- Study start
- Aug 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care. |
| Intervention | Experimental | Behavioral: Standardized nutritional program, Behavioral: standardized exercize program, Dietary Supplement: Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)Nutrition and exercise program including a nutritional supplement. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized nutritional programThe 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. | Behavioural | Intervention |
| standardized exercize programThe 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. | Behavioural | Intervention |
| 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. | Dietary supplement | Intervention |
Primary outcome
Quality of Life (QoL)
Time frame: 3 months
Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G). Total scores range from 0-108 points, with higher scores reflecting better QoL.
21 secondary outcomes
Fatigue
Time frame: 3 months
Nutritional status
Time frame: 3 months.
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Nutritional status
Time frame: 3 months
Physical function
Time frame: 3 months
Physical function
Time frame: 3 months
Physical function
Time frame: 3 months
Appetite
Time frame: 3 months
Appetite
Time frame: 3 months
Energy- and protein intake
Time frame: 3 months
Adherence to the nutrition and exercise program
Time frame: 3 months
Succes of recruitment rate in comparison to former studies
Time frame: Throughout recruitment phase.
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Clinical data
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Britschgi, PD Dr. med. Dr. phil. principal investigator
Kantonsspital Winterthur KSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standardized nutritional program, standardized exercize program and Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB) in people with Cancer, Advanced Solid Tumors and Malnutrition, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Gafner, Dr. sc. nat. (+41 52 266 21 37, lucia.gafner@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (QoL) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.