Actively Recruiting
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
Eligibility Criteria
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
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
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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