NephrotoxicityPhase 2/3VitC-CoQ10NCT07476443
Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity
A Phase 2/3 study testing Vitamin C and Coenzyme Q 10 in people with Nephrotoxicity, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nephrotoxicity
- What is being tested?
- Vitamin C and Coenzyme Q 10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2026to 20 Aug 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Hematologic parameters (WBC count ≥ 3,000/mm³ -- Platelet count ≥ 75,000/mm³-- Hb level ≥ 8.0 g/dL)
- Alanine aminotransferase (ALT) ≤3×(ULN).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Nasser Institute for Research and Treatment
Cairo, Shoubra, 11617
Rasha M AbdelMotagalee, Senior, 01067366826 ext. 02, elsayedonco@hotmail.com
Mohammed H, 01002406744 ext. 02
About this study
Official title: The Potential Renoprotective Effect of Vitamin c and Coenzyme q10 Against Cisplatin Induced Nephrotoxicity in Cancer Patients
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.
Read the detailed description
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.
- Conditions
- Nephrotoxicity
- Being tested
- Vitamin C, Coenzyme Q 10
- Keywords
- Cisplatin, Vitamin C, CoQ10, cancer, nephrotoxicity, KIM-1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Ascorbic acid
Vitamin C 500 mg administered orally
Coenzyme Q 10Drug
Also called CoQ10
30 mg administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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 ). Receives: Drug: Vitamin C |
| 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 ). Receives: Drug: Coenzyme Q 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 cycles (21 days each).
Secondary outcomes (2)
KIM-1 biomarker levels
As an early indicator of acute cisplatin induced kidney injury.
Measured: 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
Measured: 3 cycles (21 days each) and it will be measured by the end of the third cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrotoxicityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ghada saeid, Ain Shams University
- Investigators
- Nagwa A Sabri, PHD, Principal investigator, Professor of Clinical Pharmacy-Faculty of Pharmacy-Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476443
- Sponsor's protocol ID
- 2020110301
- Acronym
- VitC-CoQ10
- Status last verified
- Sep 2025
- First submitted
- 8 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 28197460
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Renoprotective Effect of Vitamin c and Coenzyme q10 Against Cisplatin Induced Nephrotoxicity in Cancer Patients
- ClinicalTrials.gov ID
- NCT07476443
- Acronym / sponsor ID
- VitC-CoQ10 / 2020110301
- Conditions
- Nephrotoxicity
- Keywords
- Cisplatin, Vitamin C, CoQ10, cancer, nephrotoxicity, KIM-1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –25 patients will receive only the standard of care as the chemotherapy regimen consists of ; cisplatin+gemcitabine. |
| Vit C | Active comparator | Drug: Vitamin C25 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 | Drug: Coenzyme Q 1025 patients will receive Coenzyme q10 30 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Hematologic parameters (WBC count ≥ 3,000/mm³ -- Platelet count ≥ 75,000/mm³-- Hb level ≥ 8.0 g/dL)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: Ascorbic acidVitamin C 500 mg administered orally | Drug | Vit C |
| Coenzyme Q 10Also: CoQ1030 mg administered orally | Drug | CoQ10 |
Primary outcome
Evaluation of the potential protective effects of Vitamin C and Coenzyme Q10 against cisplatin-induced nephrotoxicity in chemotherapy-naïve cancer patients.
Time frame: 3 cycles (21 days each).
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
2 secondary outcomes
KIM-1 biomarker levels
Time frame: 3 cycles (21 days each).
Assesment of the quality of life
Time frame: 3 cycles (21 days each) and it will be measured by the end of the third cycle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Background: PubMed 28197460Hajian S, Rafieian-Kopaei M, Nasri H. Renoprotective effects of antioxidants against cisplatin nephrotoxicity. J Nephropharmacol. 2014 Jul 1;3(2):39-42. eCollection 2014.
- Individual participant dataSharing planned: No. 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.
Related trials for Nephrotoxicity
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Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Renal Cancer, Renal Secondary Cancer
Not yet recruitingObservational study
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
Biomarkers, Acute Kidney Injury
Enrolling by invitation
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
Nephrotoxicity, Acute Kidney Injuries
Active, not recruitingPhase 3
Cisplatin Disposition and Kidney Injury
Nephrotoxicity
Not yet recruitingPhase 1
Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction
Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nagwa A Sabri, PHD principal investigator
Professor of Clinical Pharmacy-Faculty of Pharmacy-Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin C and Coenzyme Q 10 in people with Nephrotoxicity, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada S Elseidy, Master (01124006769 ext. 02, ghada.ms2324013@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the potential protective effects of Vitamin C and Coenzyme Q10 against cisplatin-induced nephrotoxicity in chemotherapy-naïve cancer patients. (time frame: 3 cycles (21 days each).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07476443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.