Curcumin Supplementation in Cervical Cancer
Evaluation of Curcumin Supplementation on p53 Levels and Apoptosis in Tumor Cells From Patients With Locally Advanced Cervical Cancer
National Institute of Cancerología
30 participants
Apr 19, 2023
INTERVENTIONAL
Conditions
Summary
Brief Summary. The goal of this pilot study is to learn about the effect of curcumin supplementation in locally advanced cervical cancer patients. The main questions it aims to answer are: * Does curcumin supplementation increase the levels of p53 and apoptosis in tumor cells from cervical cancer patients? * At which dose of curcumin supplementation is the broader effect observed for p53 expression and apoptosis in tumor cells from cervical cancer patients? * Are all doses safe for supplementation? Participants will be asked to take curcumin tablets throughout their cancer treatment. Researchers will compare 6 different groups, each group will receive a different dose of curcumin with or without piperin, to see the dose with the broader effect and safety of curcumin supplementation: 1. 1 g of curcumin 2. 1 g of curcumin + piperine 3. 3 g of curcumin 4. 3 g of curcumin + piperine 5. 6 g of curcumin 6. 6 g of curcumin + piperine
Eligibility
Inclusion Criteria13
- Understanding the nature of the study and giving a written consent report.
- Women \> 18 years old.
- ECOG performance status: 0-2.
- Be willing and able to comply with scheduled visits, treatment plans, and laboratory tests.
- Patients with a histological cervical cancer diagnosis: squamous cell, adenosquamous, adenocarcinoma, and glassy cell carcinoma.
- Classified with clinical stage IB3-IVA (FIGO 2018).
- Candidates to receive concomitant QT-RT followed by BT.
- With disease measurable by any imaging method (CT/MRI/PET-CT) according to RECIST v 1.1 criteria.
- Patients without prior treatment based on QT-RT.
- Hemoglobin ≥ 10 g/dL.
- Leukocytes ≥ 4000/mm3.
- Platelets ≥ 100,000/mm3.
- Adequate liver function.
Exclusion Criteria5
- Patients undergoing nutritional treatment or ingesting any dietary supplement, including those containing turmeric or turmeric derivatives, ginger, or rhizome of the turmeric family.
- Patients with uncontrolled intercurrent diseases, including active infections that contraindicate CT.
- Patients receiving concomitant treatment with an experimental drug.
- Patients with vesicovaginal or vesicorectal fistula are diagnosed.
- Patients with previous or concomitant malignancy except non-melanoma skin carcinoma.
Interventions
Patients will receive capsules with curcumin C3 (Sabinsa Corp, NJ, USA) containing 1g of curcumin. They will be instructed to consume orally 1 capsule with breakfast for group 1, 1 capsule with each meal for group 3, and 2 capsules with each food for group 5.
Patients will receive capsules with curcumin C3 (Sabinsa Corp, NJ, USA) containing 1g of curcumin additioned with 5 mg of piperine. They will be instructed to consume orally 1 capsule with breakfast for group 2, 1 capsule with each meal for group 4, and 2 capsules with each meal for group 6.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06080841