A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patient… (NCT07722806) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors
Switzerland130 participantsStarted 2026-08
Plain-language 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.
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-r…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.