NCT07722806

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
28mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

2.2 years

First QC Date

July 20, 2026

Last Update Submit

July 24, 2026

Conditions

Cancer, Advanced Solid TumorsMalnutrition

Keywords

CancerPalliativeNutritionExerciseQuality of LifeLeucineHMBOlanzapineProtein supplementation

Outcome Measures

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.

    3 months

Secondary Outcomes (21)

  • Fatigue

    3 months

  • Nutritional status

    3 months.

  • Nutritional status

    3 months

  • Nutritional status

    3 months

  • Nutritional status

    3 months

  • +16 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Standard care.

Intervention

EXPERIMENTAL

Nutrition and exercise program including a nutritional supplement.

Behavioral: Standardized nutritional programBehavioral: standardized exercize programDietary Supplement: Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)

Interventions

Standardized nutritional programBEHAVIORAL

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.

Intervention
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.

Intervention
standardized exercize programBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Ability to participate in physical exercise, as judged by the treating oncologist
  • Anticipated life expectancy of at least six months
  • Willingness to provide written informed consent

You may not qualify if:

  • 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
  • Current use of any antipsychotic or antidepressant medication
  • Recent use of systemic corticosteroids (prednisolone ≥10 mg/d or equivalent) for more than seven days within the past four weeks
  • Presence of ascites at time of enrolment
  • Concurrent radiotherapy to the esophagus
  • Intake of products with added high-dose BCAA (branched-chain amino acids, total ≥3 g/d) within the past month
  • Tube feeding and/or parenteral nutrition within the previous month (excluding ONS (oral nutritional supplements)
  • History of ileus within the past month
  • Allergy to milk protein
  • Inability to comprehend trial information due to language barriers, cognitive or psychological limitations, or disease-related factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

NeoplasmsMalnutritionMotor Activity

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavior

Study Officials

  • Christian Britschgi, PD Dr. med. Dr. phil.

    Kantonsspital Winterthur KSW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Gafner, Dr. sc. nat.

CONTACT

+41 52 266 21 37lucia.gafner@ksw.ch

Esther Gerrits, Dr. med.

CONTACT

+41 52 266 38 10esther.gerrits@ksw.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) with other researchers.

Locations

CH(1)