Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity (VitC-CoQ10)

March 12, 2026 updated by: ghada saeid, Ain Shams University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Shoubra
      • Cairo, Shoubra, Egypt, 11617
        • Nasser Institute for Research and Treatment
        • Contact:
        • Contact:
          • Mohammed H
          • Phone Number: 02 01002406744
        • Principal Investigator:
          • Rasha M AbdelMotagalee, Consultant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
25 patients will receive only the standard of care as the chemotherapy regimen consists of ; cisplatin+gemcitabine.
Active Comparator: Vit C
25 patients will receive Vitamin C 500 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ).
Drug: Vitamin C
Vitamin C 500 mg administered orally
Other Names:
  • Ascorbic acid
Active Comparator: CoQ10
25 patients will receive Coenzyme q10 30 mg administered orally once daily for 10 days. (for 2 days before day 1 for each cycle ).
Drug: Coenzyme Q 10
30 mg administered orally
Other Names:
  • CoQ10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
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
3 cycles (21 days each).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KIM-1 biomarker levels
Time Frame: 3 cycles (21 days each).
As an early indicator of acute cisplatin induced kidney injury.
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

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
3 cycles (21 days each) and it will be measured by the end of the third cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Nagwa A Sabri, PHD, Professor of Clinical Pharmacy-Faculty of Pharmacy-Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

May 20, 2027

Study Completion (Estimated)

August 20, 2027

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020110301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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