Exercise and nutrition program for patients with gastrointestinal cancer
Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.
This study tests whether a combined exercise and nutrition program can help people with gastric and pancreatic cancer feel better during chemotherapy and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Beatriz Ângelo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Loures, Lisboa and 1 other locations) |
| Trial ID | NCT05420259 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a Combined Exercise and Dietary Intervention (CEDI) on patients with gastric and pancreatic cancer undergoing neoadjuvant chemotherapy. The approach aims to modulate inflammation and improve skeletal muscle mass, potentially enhancing chemotherapy response and preventing cancer cachexia. By optimizing nutritional status during the neoadjuvant treatment period, the study seeks to explore the impact on cytokine profiles and tumor immune response. Participants will receive both the CEDI and standard care throughout the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 80 with stage II/III gastric or pancreatic cancer who are eligible for neoadjuvant chemotherapy and have a low level of physical activity.
Not a fit: Patients with a life expectancy of less than 12 months, metastatic disease, or significant comorbidities that limit physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve treatment outcomes and quality of life for patients with gastrointestinal cancers.
How similar studies have performed: While some studies have explored exercise in cancer care, this specific combined approach during neoadjuvant treatment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy, * age higher than 40 years and lower than 80 years, * ECOG (Eastern Cooperative Oncology Group) functional status: 0-2, * sedentary/low physical activity level. Exclusion Criteria: * life expectancy less than 12 months at inclusion, * chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer, * metastatic disease, * chronic anti-inflammatory medication use, * known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis) * cardiovascular, respiratory or musculoskeletal or joint problems that preclude moderate physical activity.
Where this trial is running
Loures, Lisboa and 1 other locations
- Hospital Beatriz Ângelo — Loures, Lisboa, Portugal (Recruiting)
- Hospital da Luz — Lisboa, Portugal (Not_yet_recruiting)
Study contacts
- Study coordinator: Sónia Velho
- Email: soniavelho0@gmail.com
- Phone: +351914644141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.