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NCT07722806

Overview

NCT ID: NCT07722806
Lead Sponsor: Kantonsspital Winterthur KSWOTHER
Official Title: A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Randomized Controlled Intervention Trial in Patients With Advanced Tumors
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Oct 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 130Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Lucia Gafner, Dr. sc. nat.Contact
lucia.gafner@ksw.ch+41 52 266 21 37

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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