Concomitant Curcumin Palliative Radiotherapy in Advanced Cervical Cancer Trial

Ki vehet részt

• 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 ≥1.500/mm3; platelet count ≥100.000/mm3; hemoglobin ≥10.0 g/dL); renal function (serum creatinine ≤1.5 x ULN; estimate creatinine clearance (Cockcroft-Gault) ≥60 mL/min)
• 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

Ki nem vehet részt

• 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
• Cervical cancer patients who are candidates for single dose palliative radiotherapy
• 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), uncontrolled hypertension, heart failure, cardiac arrhythmia, unstable angina, chronic obstructive lung disease, diabetes mellitus, chronic renal disease, chronic liver disease, biliary tract obstruction or cholelithiasis, gastric or duodenal ulcers, autoimmune or inflammatory disorders, a coagulation or platelet disorder, seizure disorders and psychiatric illness. Patients with disorders other than the ones specified above may also be excluded based on the judgment of the principal investigator
• Patients with severe or bilateral hydronephrosis
• Evidence of distant metastases
• 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