Phase
Condition
Cervical Cancer
Pelvic Cancer
Dysfunctional Uterine Bleeding
Treatment
Palliative radiotherapy
Curcumin
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Age >18 years old (Adult, Older Adult)
Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamouscarcinoma of the cervix, FIGO stage IIIB-IVA
Undergoing for standard of care palliative radiotherapy without chemotherapy as perthe local treatment guideline
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Adequate liver function (aspartate aminotransferase (AST) and alanineaminotransferase (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; plateletcount ≥100.000/mm3; hemoglobin ≥10.0 g/dL); renal function (serum creatinine ≤1.5 xULN; estimate creatinine clearance (Cockcroft-Gault) ≥60 mL/min)
Participants must have measureable disease according to the Response EvaluationCriteria in Solid Tumors (RECIST) V1.1.
Agree to use an effective form of contraception (e.g., true abstinence (not periodicabstinence), barrier contraception, highly effective hormonal contraception) if theparticipant is of child bearing age
Give informed consent
Exclusion
Exclusion criteria:
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 weeksbefore enrollment
Received any previous radiation or chemotherapy for cervical cancer
Underwent surgery in the four weeks prior to the enrolment date or scheduled toundergo surgery within eight weeks after end of treatment
Currently using of any chemotherapy or scheduled to receive within eight weeks afterend 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 trialintervention and/or prohibit adequate compliance to study requirements includingchronic ongoing infections (like HIV, Hepatitis B or C), uncontrolled hypertension,heart failure, cardiac arrhythmia, unstable angina, chronic obstructive lungdisease, diabetes mellitus, chronic renal disease, chronic liver disease, biliarytract obstruction or cholelithiasis, gastric or duodenal ulcers, autoimmune orinflammatory disorders, a coagulation or platelet disorder, seizure disorders andpsychiatric illness. Patients with disorders other than the ones specified above mayalso be excluded based on the judgment of the principal investigator.
Pregnant and breastfeeding women
Participants with circumstances that will not permit completion of the study orrequired follow-up. For instance, if travel to and from treatment site is an issue.
Study Design
Connect with a study center
Tikur Anbessa Specialized Hospital
Addis Ababa,
EthiopiaActive - Recruiting
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