Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity
ConditionNephrotoxicity
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University
About this trial
Cisplatin is a widely used chemotherapy drug for many solid tumors (e.g., lung, bladder, ovarian, head and neck cancers). Despite its efficacy, its clinical use is limited by severe side effects, mainly nephrotoxicity, which occurs in \~30% of patients after treatment. Once inside cells, cisplatin undergoes activation, leading to DNA and mitochondrial damage, oxidative stress, inflammation, apoptosis, and eventual acute kidney injury (AKI) or chronic kidney disease (CKD). Vitamin C (ascorbic acid) is a water-soluble antioxidant with broad protective roles, including free radical scavenging, DNA and protein protection, and glutathione restoration. Coenzyme Q10 (CoQ10) is a lipid-soluble antioxidant involved in mitochondrial energy production and regeneration of other antioxidants (vitamins C \& E). Both antioxidants are generally safe at studied doses, with only mild gastrointestinal side effects reported. Therefore, evaluating their role in preventing cisplatin-induced nephrotoxicity in cancer patients is clinically valuable.
Aim of the study :
This study aims to evaluate the protective effects of (Vitamin C and Coenzyme q10) against cisplatin-induced nephrotoxicity in chemotherapy-naïve cancer patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chemotherapy-naïve patients diagnosed with different types of cancer.
Age :adult patients (aged 18-65 years)
Candidates eligible for induction chemotherapy (cisplatin+gemcitabine). Baseline (eGFR) ≥60 ml/min/1.73 m².
Eastern Cooperative Oncology Group (ECOG) performance status <2.
Disqualifiers
Prior chemotherapy.
Uncontrolled Diabetes mellitus, active infection, heart failure, liver impairment, gastritis or G-6-P) deficiency.
History of nephrotoxic drugs use over the past 3 months prior to recruitment (e.g., aminoglycosides, amphotericin B, or vancomycin).
Known allergy to any of the study drugs.
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin C
DrugVitamin C 500 mg administered orally
Coenzyme Q 10
Drug30 mg administered orally
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: controlNo intervention 0 interventions
Group B: Vit CActive comparator 1 intervention
Group C: CoQ10Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the potential protective effects of Vitamin C and Coenzyme Q10 against cisplatin-induced nephrotoxicity in chemotherapy-naïve cancer patients.
The Incidence and severity of nephrotoxicity is the main outcome as The assessment based on serum creatinine elevation and Graded according to CTCAE version 5.0 Unit of Measure: CTCAE grade
Time frame
3 cycles (21 days each).Secondary outcomes
1
KIM-1 biomarker levels
As an early indicator of acute cisplatin induced kidney injury.
Time frame
3 cycles (21 days each).2
Assesment of the quality of life
Assesment of the quality of life through The European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) questionnaire as it consists of 30 items that assess five functional domains, three symptom domains, a global health status/quality-of-life scale and each item is scored on a 4-point Likert scale:1 for Not at all and 4 for Very much, but the global health status items are scored on a 7-point scale ranging from very poor to excellent. Scores are linearly transformed to a 0-100 scale: Higher functional scores = better functioning / better QoL Higher symptom scores = greater symptom burden
Time frame
3 cycles (21 days each) and it will be measured by the end of the third cycleSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: