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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Standardized nutritional program
BehavioralThe 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
BehavioralThe 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 supplementThe 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Fatigue
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Total scores range from 0-52 points, with higher scores reflecting less pronounced fatigue.
Nutritional status
Body weight (in kg), used in combination with body height to calculate BMI (kg/m2)
Nutritional status
Bioelectrical impedance analysis (BIA)
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)
Sponsors and contacts
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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: