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Curcumin Supplementation in Cervical Cancer

RECRUITINGN/ASponsored by National Institute of Cancerología
Actively Recruiting
PhaseN/A
SponsorNational Institute of Cancerología
Started2023-04-19
Est. completion2025-12
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

1. Understanding the nature of the study and giving a written consent report.
2. Women \> 18 years old.
3. ECOG performance status: 0-2.
4. Be willing and able to comply with scheduled visits, treatment plans, and laboratory tests.
5. Patients with a histological cervical cancer diagnosis: squamous cell, adenosquamous, adenocarcinoma, and glassy cell carcinoma.
6. Classified with clinical stage IB3-IVA (FIGO 2018).
7. Candidates to receive concomitant QT-RT followed by BT.
8. With disease measurable by any imaging method (CT/MRI/PET-CT) according to RECIST v 1.1 criteria.
9. Patients without prior treatment based on QT-RT.
10. Hemoglobin ≥ 10 g/dL.
11. Leukocytes ≥ 4000/mm3.
12. Platelets ≥ 100,000/mm3.
13. Adequate liver function.

Exclusion Criteria:

1. Patients undergoing nutritional treatment or ingesting any dietary supplement, including those containing turmeric or turmeric derivatives, ginger, or rhizome of the turmeric family.
2. Patients with uncontrolled intercurrent diseases, including active infections that contraindicate CT.
3. Patients receiving concomitant treatment with an experimental drug.
4. Patients with vesicovaginal or vesicorectal fistula are diagnosed.
5. Patients with previous or concomitant malignancy except non-melanoma skin carcinoma.

Conditions2

CancerLocally Advanced Cervical Cancer

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