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

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.

Conditions

• Cancer, Advanced Solid Tumors
• Malnutrition

Interventions

BEHAVIORAL

Standardized nutritional program

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.

BEHAVIORAL

standardized exercize program

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Krebsforschung Schweiz, Bern, Switzerland

  collaborator OTHER

• Sponser Sport Food AG

  collaborator UNKNOWN

• HOCH Health Ostschweiz, Kantonsspital St. Gallen

  collaborator UNKNOWN

• Kantonsspital Winterthur KSW

  lead OTHER

Principal Investigators

• Christian Britschgi, PD Dr. med. Dr. phil. · Kantonsspital Winterthur KSW

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2028-10-31

Completion

2028-12-31

Countries

• Switzerland

Study Locations