About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Curcumin
- Curcumin + Piperine
Treatment groups
6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
National Institute of Cancerología
Lead sponsor
Sabinsa Corporation
Collaborator