Status:
WITHDRAWN
Quality of Life With Nutritional Supplementation in Patients With Locally Advanced/Metastatic Pancreatic Cancer.
Lead Sponsor:
Fundacion para la Excelencia y la Calidad de la Oncologia
Conditions:
Quality of Life
Locally Advanced Pancreatic Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 extrac...
Detailed Description
This study is composed of two phases: pilot phase and experimental phase. The pilot phase is also composed of two stages: first stage of pilot phase and second stage of pilot phase. There are 22 pati...
Eligibility Criteria
Inclusion
- 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
- .
- 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.
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05360745
Start Date
June 29 2022
End Date
September 12 2023
Last Update
September 14 2023
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