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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Standardized nutritional program

    Behavioral

    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 program

    Behavioral

    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.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

Fatigue

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Total scores range from 0-52 points, with higher scores reflecting less pronounced fatigue.

Time frame
3 months
2

Nutritional status

Body weight (in kg), used in combination with body height to calculate BMI (kg/m2)

Time frame
3 months.
3

Nutritional status

Bioelectrical impedance analysis (BIA)

Time frame
3 months
4

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)

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kantonsspital Winterthur KSW

Lead sponsor

Krebsforschung Schweiz, Bern, Switzerland

Collaborator

Sponser Sport Food AG

Collaborator

HOCH Health Ostschweiz, Kantonsspital St. Gallen

Collaborator

This trial is not recruiting at the moment. You can still explore other options: