Curcumin Supplementation in Cervical Cancer
ConditionLocally Advanced Cervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Institute of Cancerología
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Curcumin
Dietary supplementPatients 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.
Curcumin + Piperine
Dietary supplementPatients 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.
Treatment groups
30 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Group E: Group 5Experimental treatment 1 intervention
Group F: Group 6Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
p53 expression
Using the liquid-based cervicovaginal cytology samples, p53 will be quantified by the ELISA method. p53 positive cells will be quantified through flow cytometry.
Time frame
Through study completion, an average of 3 years2
Frequency of Apoptosis
A conjugate of Annexin V and fluorophore will be used to determine apoptosis in cells from liquid-based cytology, through flow cytometry. The number of apototic cells (positive for Annexin V) will be quantified, and the percentage will be calculated.
Time frame
Through study completion, an average of 3 yearsSecondary outcomes
1
Frequency of Gastrointestinal toxicity
Symptoms of gastrointestinal toxicity will be recorded and graded at each visit during treatment according to the common toxicity criteria of adverse events (CTCAE v.5). Frequency and severity will be assessed.
Time frame
Through study completion, an average of 3 years2
Bioavailability of curcumin
To determine the bioavailability of curcumin, blood, fecal, and urine samples will be obtained. It is proposed to use Chen's method (1997) with some modifications to determine the total amount of bioactive, including lupeol and polyphenols free and in conjugated form; the methodology will depend on the corresponding biological sample, by ultra-high resolution liquid chromatography with chemical ionization at atmospheric pressure coupled or electrospray ionization with MS (UPLC-API or ESI-MS/MS)
Time frame
Through study completion, an average of 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Institute of Cancerología
Lead sponsor
Sabinsa Corporation
Collaborator
Source ClinicalTrials.gov