Curcumin Supplementation in Cervical Cancer

NCT06080841 | Recruiting DMC

• 1 other identifier: CEI/1598/21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 g of curcumin
• 1 g of curcumin + piperine
• 3 g of curcumin
• 3 g of curcumin + piperine
• 6 g of curcumin
• 6 g of curcumin + piperine

Conditions

Locally Advanced Cervical Cancer

Keywords

curcumin; locally advanced cervical cancer; p53; apoptosis; chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, an average of 3 years

• 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.

  Through study completion, an average of 3 years

Secondary Outcomes (2)

• Frequency of Gastrointestinal toxicity

  Through study completion, an average of 3 years

• Bioavailability of curcumin

  Through study completion, an average of 3 years

Study Arms (6)

Group 1

EXPERIMENTAL

1g of curcumin.

Dietary Supplement: Curcumin

Group 2

EXPERIMENTAL

1 g curcumin + 5 mg piperine.

Dietary Supplement: Curcumin + Piperine

Group 3

EXPERIMENTAL

3 g of curcumin.

Dietary Supplement: Curcumin

Group 4

EXPERIMENTAL

3 g curcumin + 15 mg piperine.

Dietary Supplement: Curcumin + Piperine

Group 5

EXPERIMENTAL

6 g of curcumin.

Dietary Supplement: Curcumin

Group 6

EXPERIMENTAL

6 g curcumin + 15 mg piperine.

Dietary Supplement: Curcumin + Piperine

Interventions

Curcumin DIETARY_SUPPLEMENT

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.

Group 1; Group 3; Group 5

Curcumin + Piperine DIETARY_SUPPLEMENT

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.

Group 2; Group 4; Group 6

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cancerología: lead
• Sabinsa Corporation: collaborator

Study Sites (1)

Instituto Nacional de Cancerología

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Interventions

Curcumin; piperine

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Denisse Castro, RDN, PhD

  Conacyt / National Cancer Institute of Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denisse Castro-Eguiluz, RDN, PhD

CONTACT

+525541940650; adcastro@conahcyt.mx

Alejandro García Carrancá, PhD

CONTACT

+525555086910; carranca@biomedicas.unam.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A pilot study in adult women diagnosed with cervical cancer in locally advanced stages (IB3-IVA), who are selected to undergo treatment with concomitant QT-RT followed by BT, by the Functional Gynecology Oncology Unit of the National Cancer Institute. The intervention will be supplementation with different doses of curcumin. Patients will eat a standard diet according to their requirements. The aim is to describe the expression of p53 protein levels and apoptosis in tumor cells from these patients. Patients will be monitored by a nutritionist and receive the corresponding care from the medical oncologist. Sample size. Because this is a pilot study, the sample size will be at the researcher's convenience; 5 patients per group, 30 patients with locally advanced cervical cancer, who are candidates to receive standard treatment of concomitant chemoradiotherapy, followed by brachytherapy. Blood, urine, fecal, and cervicovaginal cytology samples will be collected.

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 12, 2023
• Study Start: April 19, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)