A Phase 2 interventional study of Standardized nutritional program and standardized exercize program in Cancer, Advanced Solid Tumors and Malnutrition, sponsored by Kantonsspital Winterthur KSW. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Kantonsspital Winterthur KSW · Phase 2, Interventional, and Supportive care
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.
Cancer-related malnutrition represents a major clinical challenge. It is characterized by involuntary weight loss, muscle wasting, functional decline, reduced quality of life (QoL), longer and more frequent hospitalizations, and an increased risk for complications. Together, these factors substantially increase healthcare costs.
Despite growing awareness, evidence from robust randomized trials on multimodal interventions remains limited. Effective management requires a coordinated, multidisciplinary, and multimodal strategy.
The combination of nutritional counseling, physical exercise, and olanzapine (an ASCO-recommended appetite stimulant used according to standard care) may synergistically improve QoL (primary endpoint; Functional Assessment of Cancer Therapy - General; FACT-G), as well as nutritional status, energy intake, fatigue, muscle mass, and strength (secondary endpoints) in patients with advanced cancer.
With this prospective, randomized controlled trial, we aim to investigate whether adding a structured nutrition and exercise intervention to olanzapine improves QoL after 12 weeks of the program, compared to olanzapine alone.
Eligible outpatients with metastatic or locally advanced solid tumors and appetite loss will be randomized to either:
All participants will receive low-dose olanzapine for the treatment of appetite loss according to standard clinical care, with treatment initiated after the baseline assessment at the start of the 12-week program.
Both arms will be assessed at baseline (0 weeks), after the 12-week intervention phase, and at a follow-up assessment after 24 weeks.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 130 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Kantonsspital Winterthur KSW is the lead sponsor of 34 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard care.
Nutrition and exercise program including a nutritional supplement.
Behavioral: Standardized nutritional program · Behavioral: standardized exercize program · Dietary Supplement: Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)
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.
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.
The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably in the evening or post-exercise.
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
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
Nutritional status
Body weight (in kg), used in combination with body height to calculate BMI (kg/m2)
Time frame: 3 months.
Nutritional status
Bioelectrical impedance analysis (BIA)
Time frame: 3 months
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
Nutritional status
Calf circumference (cm)
Time frame: 3 months
Nutritional status
Sarcopenia questionnaire: sarcopenia functional assessment (SARC-F). Total scores range from 0-10 points, with higher scores reflecting higher sarcopenia risk.
Time frame: 3 months
Nutritional status
Patient-generated subjective global assessment, short form, PG-SGA SF. Total scores range from 0-36 points, with lower scores reflecting better nutritional status.
Time frame: 3 months
Nutritional status
Global Leadership Initiative of Malnutrition (GLIM) criteria, a diagnositic tool for malnutrition, focusing on phenotypic and etiologic criteria.
Time frame: 3 months
Physical function
Handgrip strength
Time frame: 3 months
Physical function
60-second sit-to-stand test
Time frame: 3 months
Physical function
6-minute walk test
Time frame: 3 months
Appetite
Visucal analog scale (VAS) for appetite. Total scores range from 0-100, with higher scores reflecting better Appetite.
Time frame: 3 months
Appetite
Anorexia-cachexia scale (A/CS). Total scores range from 0-48 points, with higher scores reflecting better Appetite.
Time frame: 3 months
Energy- and protein intake
Data collected with food diaries; Harris-Benedic formula
Time frame: 3 months
Adherence to the nutrition and exercise program
Completed counseling sessions; supplement intake; adherence based on data recorded in the journal
Time frame: 3 months
Succes of recruitment rate in comparison to former studies
Number of eligible patients, participants, rejections as compared to similar past studies
Time frame: Throughout recruitment phase.
Clinical data
Physical performance status (WHO performance status, grade 0-5)
Time frame: 3 months
Clinical data
Overall survival
Time frame: 3 months
Clinical data
Adverse events (AEs) grade 3 and 4
Time frame: 3 months
Clinical data
Serious adverse events (SAEs; unplanned hospitalizations)
Time frame: 3 months
Clinical data
Progression free survival
Time frame: 3 months
Plan to share: No — There is no plan to share individual participant data (IPD) with other researchers.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Oct 2028, 26 months later.
Of 335 non-industry phase 2 interventional studies under Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 99. This study's planned 26 months is below that.
Counting every sponsor, half of 514 studies reached it within 52 months; a quarter within 33 and three quarters within 92.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Kantonsspital Winterthur KSW