Evaluation of Curcumin Supplementation on p53 Levels and Apoptosis in Tumor Cells From Patients With Locally Advanced Cervical Cancer

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Instituto Nacional de Cancerología
RECRUITING
Mexico City
Contact Information
Primary
Denisse Castro-Eguiluz, RDN, PhD
adcastro@conahcyt.mx
+525541940650
Backup
Alejandro García Carrancá, PhD
carranca@biomedicas.unam.mx
+525555086910
Time Frame
Start Date: 2023-04-19
Estimated Completion Date: 2026-03
Participants
Target number of participants: 30
Treatments
Experimental: Group 1
1g of curcumin.
Experimental: Group 2
1 g curcumin + 5 mg piperine.
Experimental: Group 3
3 g of curcumin.
Experimental: Group 4
3 g curcumin + 15 mg piperine.
Experimental: Group 5
6 g of curcumin.
Experimental: Group 6
6 g curcumin + 15 mg piperine.
Related Therapeutic Areas
Sponsors
Collaborators: Sabinsa Corporation
Leads: National Institute of Cancerología

This content was sourced from clinicaltrials.gov