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New treatment option for Cervical Cancer
Official title Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial
ClinicalTrials.gov ID: NCT05947513
What this study is testing
What is Curcumin?
Curcumin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cervical cancer.
Also referred to as Curcumagalactomannoside (CGM), CurQfen.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to test curcumin as an adjunct treatment in patients with cervical cancer receiving standard-of-care palliative radiation. The main questions it aims to answer are: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age \>18 years old (Adult, Older Adult)
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IIIB-IVA
- Undergoing for standard of care palliative radiotherapy without chemotherapy as per the local treatment guideline
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- Adequate liver function (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (Upper Limit of Normal); total serum...
You likely can't join if
- Cervical cancer patients who are candidates for single dose palliative radiotherapy
- Patients with severe or bilateral hydronephrosis
- Evidence of distant metastases
- Receiving any other investigational agent concurrently or within the last 4 weeks before enrollment
- Received any previous radiation or chemotherapy for cervical cancer
- Underwent surgery in the four weeks prior to the enrolment date or scheduled to undergo surgery within eight weeks after end of treatment
See the full eligibility criteria
- Age \>18 years old (Adult, Older Adult)
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IIIB-IVA
- Undergoing for standard of care palliative radiotherapy without chemotherapy as per the local treatment guideline
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- Adequate liver function (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (Upper Limit of Normal); total serum bilirubin ≤1.5 x ULN); blood cell counts (absolute neutrophils count...
- Participants must have measureable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1.
- Agree to use an effective form of contraception (e.g., true abstinence (not periodic abstinence), barrier contraception, highly effective hormonal contraception) if the participant is of child bearing age
- Give informed consent
- Cervical cancer patients who are candidates for single dose palliative radiotherapy
- Patients with severe or bilateral hydronephrosis
- Evidence of distant metastases
- Receiving any other investigational agent concurrently or within the last 4 weeks before enrollment
- Received any previous radiation or chemotherapy for cervical cancer
- Underwent surgery in the four weeks prior to the enrolment date or scheduled to undergo surgery within eight weeks after end of treatment
- Currently using of any chemotherapy or scheduled to receive within eight weeks after end of treatment
- Known allergy to turmeric or its derivatives (ginger, curry, cumin, or cardamom)
- Known allergy to fenugreek, peanut, soy, lentil, pea, bean, and chickpea
- Presence of conditions that precludes the safe administration of the trial intervention and/or prohibit adequate compliance to study requirements including chronic ongoing infections (like HIV, Hepatitis B or C)...
- Pregnant and breastfeeding women
- Participants with circumstances that will not permit completion of the study or required follow-up. For instance, if travel to and from treatment site is an issue.
The study team makes the final eligibility decision.
Where it's taking place
- Addis Ababa, Ethiopia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Addis Ababa, Ethiopia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.