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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.
Cisplatin is a widely used chemotherapeutic agent in the treatment of several solid tumors; however, its clinical use is limited by nephrotoxicity, which occurs in a significant proportion of patients. Cisplatin-induced renal injury is primarily associated with oxidative stress, inflammation, and mitochondrial dysfunction leading to tubular cell damage.
Vitamin C is a potent antioxidant that scavenges reactive oxygen species and may reduce oxidative damage in renal tissues. Coenzyme Q10 is an essential component of the mitochondrial electron transport chain and has strong antioxidant properties that may help protect renal cells from oxidative stress and mitochondrial injury.
This randomized controlled trial aims to evaluate the potential renoprotective effects of Vitamin C and Coenzyme Q10 in chemotherapy-naïve cancer patients receiving cisplatin-based chemotherapy. Participants will be randomly allocated to receive antioxidant supplementation along with standard chemotherapy or standard therapy alone. Renal function will be monitored during treatment to assess the protective effects of these interventions.
The findings of this study may provide evidence for efficacy to reduce cisplatin-induced nephrotoxicity and improve clinical outcomes for cancer patients undergoing chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | 25 patients will receive only the standard of care as the chemotherapy regimen consists of ; cisplatin+gemcitabine. | |
| Vit C | Active Comparator | 25 patients will receive Vitamin C 500 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ). |
|
| CoQ10 | Active Comparator | 25 patients will receive Coenzyme q10 30 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Vitamin C 500 mg administered orally |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 cycles (21 days each). |
| Measure | Description | Time Frame |
|---|---|---|
| KIM-1 biomarker levels | As an early indicator of acute cisplatin induced kidney injury. | 3 cycles (21 days each). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada S Elseidy, Master | Contact | 01124006769 | 02 | ghada.ms2324013@pharma.asu.edu.eg |
| Rana S Fouad, PHD | Contact | 01208164247 | 02 | ranasayed@pharma.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nagwa A Sabri, PHD | Professor of Clinical Pharmacy-Faculty of Pharmacy-Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nasser Institute for Research and Treatment | Cairo | Shoubra | 11617 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28197460 | Background | Hajian S, Rafieian-Kopaei M, Nasri H. Renoprotective effects of antioxidants against cisplatin nephrotoxicity. J Nephropharmacol. 2014 Jul 1;3(2):39-42. eCollection 2014. |
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As the dataset contains confidential patient-level information and institutional ethics policies restrict public data sharing, the data will be available from the corresponding author upon reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2025 | Mar 8, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| C024989 | coenzyme Q10 |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Standard of care will be given to all patients. Which includes:
The chemotherapy regimen consists of ; cisplatin+gemcitabine. day 1: gemcitabine+ cisplatin: 75 mg/m2 IV , or gemcitabine +fractionated cisplatin: 35 mg /m2 on day 1 and day 8. This regimen will be repeated every 3 weeks for 3 cycles. All patients should receive a hydration protocol based on the chemotherapy protocol. Stratified randomization based on receiving radiotherapy will be done to make sure all groups are balanced.
Intervention: Vitamin C orally (500mg) administered orally once daily for 10 days and coQ10 orally (30mg) administered orally once daily for 10 days.
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| Coenzyme Q 10 | Drug | 30 mg administered orally |
|
|
| 3 cycles (21 days each) and it will be measured by the end of the third cycle |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |