Clinical trial · Interventional
A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Trial in Patients With Advanced Tumors
A Nutrition and Exercise Program With Olanzapine Compared to Olanzapine Alone: A Randomized Controlled Intervention Trial in Patients With Advanced Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Advanced Solid Tumors | Malignant Neoplasm | ALIAS | 0.85 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standardized exercize program | Behavioral | — | UNRESOLVED |
| Standardized nutritional program | Behavioral | — | UNRESOLVED |
| Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard care.
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Nutrition and exercise program including a nutritional supplement.
- interventionNames
- Behavioral: Standardized nutritional program
- Behavioral: standardized exercize program
- Dietary Supplement: Whey protein supplement with added leucine and β-hydroxy-β-methylbutyrate (HMB)
Primary outcomes (1)
- measure
- Quality of Life (QoL)
- timeFrame
- 3 months
- description
- Questionnaire Functional Assessment of Cancer Therapy - General (FACT-G). Total scores range from 0-108 points, with higher scores reflecting better QoL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available