NCT07164534Toborzás még nem indult3. fázis
A Clinical Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity.
A Phase III Trial to Assess the Effectiveness of NRF2 Activator (Oral Sodium-copper- Chlophyllin ) in Locally Advanced Cervical Cancer to Reduce Late Radiotherapy Toxicity. (CHOC-LATE Trial)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 4.
Rövid összefoglaló (regiszter, angolul)
Cervical cancer is the second most common cancer in Indian women, and most patients are diagnosed at advanced stages. The standard treatment for these stages is concurrent chemoradiotherapy, but this can cause long-term side effects such as bladder inflammation, strictures, ulcers, and tissue damage, which negatively impact patients' quality of life. Previous studies have shown that oral sodium-copper-chlorophyllin can help reduce radiation-related side effects in rectal, prostate, and cervical cancer patients. However, no study has compared side effects between patients receiving standard follow-up care and those taking sodium-copper-chlorophyllin during follow-up. We hypothesize that the use of sodium-copper-chlorophyllin as a short-duration adjuvant is associated with reduced incidence of late grade 2 or higher gastrointestinal and genitourinary toxicities compared to patients receiving standard-of-care follow-up.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 316 (tervezett)
- Első benyújtás
- 2025. szept. 1.
- Kezdés
- 2026. márc.
- Elsődleges befejezés
- 2030. márc.
- Fő szponzor
- Tata Memorial Hospital
- Betegségek
- Méhnyakrák
- NCT-szám
- NCT07164534
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 316
- 2026. márc. és az elsődleges befejezés (2030. márc.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Subjects consuming any other concurrent investigational agents
- Subjects with any other previous or current malignancy or RT that is likely to interfere with the protocol treatment, or any other condition which, according to the principal investigator, might make an individual unsuitable for this study
- Subjects participating in any other clinical study within 90 days before enrolment in the study
Más betegség
- Subjects with known hypersensitivity or contraindication to the study drug or to any known component of the study drug formulation
- Subjects with clinically significant decreased hematologic reserves, with major organ failure, severe electrolyte or metabolic abnormalities, any active infection or any other medical condition that may interfere with the ability to receive study treatment
- HIV positive patients
- Subjects with a history of blood dyscrasias
Egyéb
- Subjects on active anti-coagulant treatment
Kiket keres a vizsgálat
- Female subjects aged 18 years or above with histologically proven locally advanced squamous cell or adenocarcinoma of the cervix
- Subjects eligible for RT and planned for definitive RT +/- chemotherapy with brachytherapy.
- Subjects who exceed the dose constraints of:
- Rectum/sigmoid D 2cm³ EQD2 ³ by more than 70 Gy, or
- Bladder D 2cm³ EQD2 ³ more than 80 Gy
- Subjects with adequate haematological, renal, hepatic and coagulation profiles and laboratory parameters within the following ranges:
- Haemoglobin: ≥ 8 g/dl
- ANC ≥ 1,500/mm\^3
- Platelet count 100,000/mm\^3
- Creatinine Clearance: ≥ 50 ml/min (as per Cockcroft-Gault formula)
- Bilirubin: ≤ 2 x Upper limit of normal (ULN)
- AST and ALT: ≤ 1.5 x ULN
- Subjects willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
- Ability to understand and willingness to sign an informed consent document
Életkor a regiszterben: 18 év – - · Nem: csak nők · Egészséges önkénteseket nem fogad
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