Clinical trial · Interventional
Nutrition Intervention During Chemotherapy
Effects of Chemotherapy and Nutritional Intervention on Gut Function and Metabolism in Cancer
- 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)
Weight loss and muscle wasting commonly occurs in patients with cancer, negatively influencing their quality of life, treatment response and survival. Weight loss has been reported as a side effect of chemotherapy treatment in cancer. Weight changes may be the consequence of energy imbalance and disturbances in protein metabolism (through different factors linked with chemotherapy), such as reduced caloric and protein intake (partly related to depression), poor treatment tolerance, hormonal alterations, systemic inflammation etc. This results in body composition modifications in favor of fat gain and/or lean body mass loss in early stage cancer and loss of both fat mass and lean mass in advanced cancer. Depletion of lean tissue in cancer patients is related to short survival, and decreased skeletal muscle mass and function may result in fatigue and inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity and increased mortality. Gains in muscle mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. Recently, the investigators observed that essential amino acid mixtures (EAA) are able to induce protein anabolism in patients with stage III and IV non-small cell lung cancer. Previous experimental research and clinical studies in cachectic conditions (including cancer) indicate that polyunsaturated fatty acids (PUFA) are able to attenuate protein degradation by improving the anabolic response to feeding and by decreasing the acute phase response. Eicosapentaenoic acid (EPA) (in combination with docosahexaenoic acid (DHA)) has been shown to effectively inhibit weight loss in several disease states; however, weight and muscle mass gain was not present or minimal. Recent studies examining the effect of fish oil supplementation in relation to chemotherapy have been inconclusive but found potential beneficial effects on physical performance and increased efficacy of first-line chemotherapy in patients with non-small cell lung cancer. It is the investigators' hypothesis that supplementation with milk protein (containing essential amino acids) carbohydrate (CHO) mixture in combination with fish oil supplementation will target the metabolic alterations in cancer patients receiving chemotherapy, attenuating the negative effects of chemotherapy on gut function, muscle mass and muscle function, and cognition; and leading to reduced toxicity from chemotherapy.
Conditions
Conditions (1)
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 Patients Receiving Chemotherapy or Chemoradiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily intake for 10 weeks (+/- 2 weeks) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Protein and Fish Oil
- description
- Low Dose (FFM \<49kg): 30.00g milk protein + 12.75g maltodextrin and 6g fish oil High dose (FFM \>49kg): 40.00g milk protein + 17.00g maltodextrin and 8g fish oil
- interventionNames
- Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks)
- type
- EXPERIMENTAL
- label
- Protein
- description
- Low Dose (FFM \<49kg): 30.00g milk protein + 12.75g maltodextrin and 6g olive oil High dose (FFM \>49kg): 40.00g milk protein + 17.00g maltodextrin and 8g olive oil
- interventionNames
- Dietary Supplement: Daily intake for 10 weeks (+/- 2 weeks)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria cancer subjects: * Diagnosed with cancer * Scheduled for chemotherapy or chemoradiotherapy * Ability to sign informed consent * Age 18y and older * Ability to lie in supine position for 7 hours Inclusion criteria healthy subjects: * Healthy male or female according to the investigator's or appointed staff's judgment * Age 18 years or older * No diagnosis of cancer Exclusion Criteria * Presence of fever within the last 3 days * BMI \> 38 kg/m2 (healthy controls only) * Untreated metabolic diseases including hepatic or renal disorder * Presence of acute illness or metabolically unstable chronic illness * Use of protein or amino acid containing nutritional supplements within 5 days of first test day * Known hypersensitivity to fish and/or shellfish, Swanson EFAs Super EPA Fish oil or any of its ingredients, Swanson EFAs Certified Organic Extra Virgin Olive oil or any of its ingredients, Smartfish Nutrifriend or any of its ingredients (Cancer subjects only) * Use of supplements containing EPA+DHA 3 months prior to the first test day * Any other condition according to the PI or nurse that would interfere with the study or safety of the patient * Failure to give informed consent * (Possible) pregnancy
References
Publications (1)
- DERIVEDHuttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print. PMID 42149813