A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorKantonsspital Winterthur KSW

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standardized nutritional program
  • standardized exercize program
  • Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)

Treatment groups

130 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kantonsspital Winterthur KSW

Lead sponsor

Krebsforschung Schweiz, Bern, Switzerland

Collaborator

Sponser Sport Food AG

Collaborator

HOCH Health Ostschweiz, Kantonsspital St. Gallen

Collaborator