Curcumin supplementation for patients with locally advanced cervical cancer

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

This study is testing if adding curcumin to the treatment of patients with locally advanced cervical cancer can improve their outcomes and find the safest dose to use.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: National Institute of Cancerología (other gov)
• Locations: 1 site (Mexico City, Mexico City)
• Trial ID: NCT06080841 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effects of curcumin supplementation on patients with locally advanced cervical cancer. Participants will receive different doses of curcumin, with or without piperine, during their chemoradiotherapy treatment. The study will assess the impact of curcumin on p53 levels and apoptosis in tumor cells, as well as the safety of various dosages. By comparing six groups, researchers hope to identify the most effective and safe dose of curcumin for enhancing treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are women over 18 years old with a histologically confirmed diagnosis of locally advanced cervical cancer (stage IB3-IVA) who are eligible for chemoradiotherapy.

Not a fit: Patients currently undergoing nutritional treatment or taking dietary supplements that include turmeric or its derivatives may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment efficacy for patients with locally advanced cervical cancer by enhancing the effects of standard therapies.

How similar studies have performed: While the use of curcumin in cancer treatment is being explored, this specific approach is novel and has not been extensively tested in similar trials.

Eligibility criteria

Inclusion Criteria:

1. Understanding the nature of the study and giving a written consent report.
2. Women \> 18 years old.
3. ECOG performance status: 0-2.
4. Be willing and able to comply with scheduled visits, treatment plans, and laboratory tests.
5. Patients with a histological cervical cancer diagnosis: squamous cell, adenosquamous, adenocarcinoma, and glassy cell carcinoma.
6. Classified with clinical stage IB3-IVA (FIGO 2018).
7. Candidates to receive concomitant QT-RT followed by BT.
8. With disease measurable by any imaging method (CT/MRI/PET-CT) according to RECIST v 1.1 criteria.
9. Patients without prior treatment based on QT-RT.
10. Hemoglobin ≥ 10 g/dL.
11. Leukocytes ≥ 4000/mm3.
12. Platelets ≥ 100,000/mm3.
13. Adequate liver function.

Exclusion Criteria:

1. Patients undergoing nutritional treatment or ingesting any dietary supplement, including those containing turmeric or turmeric derivatives, ginger, or rhizome of the turmeric family.
2. Patients with uncontrolled intercurrent diseases, including active infections that contraindicate CT.
3. Patients receiving concomitant treatment with an experimental drug.
4. Patients with vesicovaginal or vesicorectal fistula are diagnosed.
5. Patients with previous or concomitant malignancy except non-melanoma skin carcinoma.

Where this trial is running

Mexico City, Mexico City

• Instituto Nacional de Cancerología — Mexico City, Mexico City, Mexico (RECRUITING)

Study contacts

• Principal investigator: Denisse Castro, RDN, PhD — Conacyt / National Cancer Institute of Mexico
• Study coordinator: Denisse Castro-Eguiluz, RDN, PhD

Conditions: Locally Advanced Cervical Cancer, curcumin, locally advanced cervical cancer, p53, apoptosis, chemoradiotherapy