Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06080841

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

Led by National Institute of Cancerología · Updated on 2025-05-25

30

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

N

National Institute of Cancerología

Lead Sponsor

S

Sabinsa Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of curcumin supplementation in women with locally advanced cervical cancer. This pilot study aims to understand whether curcumin increases the levels of p53 protein and apoptosis (cell death) in tumor cells, to identify the dose that has the broadest effect, and to assess the safety of different doses. The study focuses on patients receiving standard cancer treatment, including chemoradiotherapy followed by brachytherapy, as cervical cancer remains a significant health issue in Mexico. Participants will be divided into six groups receiving different oral doses of curcumin tablets: 1 g, 3 g, or 6 g daily, each with or without added piperine to improve absorption. The supplementation will be taken alongside their cancer treatment. The study includes four visits: two weeks before treatment, at treatment start, after three cycles of chemoradiotherapy, and at the start of brachytherapy. At each visit, biological samples including cervical swabs, urine, serum, and feces will be collected to measure p53 expression, apoptosis, curcumin bioavailability, and gastrointestinal toxicity. During the study, researchers will monitor adherence to supplementation and assess safety through liver and kidney function tests, blood chemistry, and blood counts. Gastrointestinal symptoms will be recorded using standard criteria. The main outcomes measured are changes in p53 levels and apoptosis in tumor cells. Data will be analyzed statistically to compare the effects across different doses and combinations with piperine. The study expects to find the dose of curcumin that best supports p53 expression and tumor cell death, potentially improving treatment response and reducing side effects.

CONDITIONS

Brief Title

Curcumin Supplementation in Cervical Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women 18 years or older
  • Able to understand the study and provide written consent
  • ECOG performance status between 0 and 2
  • Willing and able to comply with visits, treatments, and tests
  • Histological diagnosis of cervical cancer: squamous cell, adenosquamous, adenocarcinoma, or glassy cell carcinoma
  • Clinical stage IB3-IVA (FIGO 2018)
  • Candidates for concomitant chemoradiotherapy followed by brachytherapy
  • Disease measurable by imaging methods according to RECIST v1.1
  • No prior chemoradiotherapy treatment
  • Hemoglobin of 10 g/dL or higher
  • Leukocytes count of 4000/mm3 or higher
  • Platelets count of 100,000/mm3 or higher
  • Adequate liver function
Not Eligible

You will not qualify if you...

  • Currently receiving nutritional treatment or taking any dietary supplements containing turmeric, ginger, or related products
  • Having uncontrolled diseases or active infections that prevent chemotherapy
  • Receiving treatment with experimental drugs
  • Diagnosis of vesicovaginal or vesicorectal fistula
  • Having previous or current cancer other than non-melanoma skin cancer

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 to 8 weeks

Participants take curcumin supplements in varying doses, with or without piperine, alongside standard chemoradiotherapy and brachytherapy for locally advanced cervical cancer. Biological samples are collected to evaluate p53 expression and apoptosis.

4 visits during treatment: 2 weeks before treatment start, at start of chemoradiotherapy, after 3 cycles of chemoradiotherapy, and at start of brachytherapy

Follow-up

Duration - Up to 3 years after treatment completion

Participants are monitored for gastrointestinal toxicity, bioavailability of curcumin, and safety through laboratory tests and symptom assessments.

Visits occur through study completion for ongoing monitoring

Trial Site Locations

Total: 1 location

1

Instituto Nacional de Cancerología

Mexico City, Mexico City, Mexico, 14080

Actively Recruiting

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Research Team

D

Denisse Castro-Eguiluz, RDN, PhD

A

Alejandro García Carrancá, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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