Clinical trial · Interventional
Quality of Life With Nutritional Supplementation in Patients With Locally Advanced/Metastatic Pancreatic Cancer.
Study of the Impact on Quality of Life of Nutritional Supplementation With a Food Supplement Versus Placebo in Patients With Locally Advanced/Metastatic Pancreatic Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Few months later the site initiation visit, the principal investigator decided not to continue with the study. He explained that his investigational team was not able to combine the study procedures with their usual clinical practice.
Summary
Brief summary (as posted)
Metastatic pancreatic cancer has a poor prognosis, with approximately one-third of patients experiencing poor quality of life at six months. ARACOMPLEX® is a food supplement that contains maca extract, vitamin complexes and ions, and this nutritional contribution seems to favor the improvement of the patient's quality of life. To verify this statement, this experimental study is carried out in patients with locally advanced/metastatic pancreatic cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARACOMPLEX® | Dietary Supplement | — | UNRESOLVED |
| placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- ARACOMPLEX® (food supplement). 2 tablets per day, during 6 months.
- interventionNames
- Dietary Supplement: ARACOMPLEX®
- type
- PLACEBO_COMPARATOR
- label
- Control arm
- description
- Placebo. 2 tablets per day, during 6 months.
- interventionNames
- Dietary Supplement: placebo
Primary outcomes (1)
- measure
- Change in quality of life
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with locally advanced or metastatic pancreatic cancer without previous chemotherapy treatment. * Patients for whom chemotherapy treatment has been indicated. * Adequate bone marrow function (neutrophils ≥1500 mm3, platelets ≥100,000 mm3), adequate liver function (bilirubin ≤1.5 times the upper limit of the normal range) * Adequate renal function (glomerular filtration rate greater than or equal to 90 ml/min/1.73). * ECOG functional stage 0-1 (Karnofsky ≥ 80). * Patients must agree to carry out study visits and procedures with precise instructions. Exclusion Criteria:. * Age ≥76 years. * Endocrine or acinar pancreatic cancer. * Serious systemic diseases such as: sepsis, heart failure, severe COPD, liver failure and chronic kidney disease. * Prior radiation to areas of measurable disease. * Chronic diarrhea. * Active infection. * Significant medical history of heart disease. * Pregnancy or lactation. * Impossibility of the patient, due to medical condition, to follow the study.
References
Publications (0)
Data not yet available