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NCT Number: NCT07476443

Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nasser Institute for Research and Treatment

Cairo, Shoubra, 11617, Egypt

Location contact

Mohammed H

CONTACT

01002406744 ext. 02

Rasha M AbdelMotagalee, Consultant

PRINCIPAL_INVESTIGATOR

Rasha M AbdelMotagalee, Senior

CONTACT

[email protected]

01067366826 ext. 02

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin C

Drug

Vitamin C 500 mg administered orally

Other names: Ascorbic acid

Coenzyme q 10

Drug

30 mg administered orally

Other names: CoQ10

Primary outcomes

  1. 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

Secondary outcomes

  1. KIM-1 biomarker levels

    Time frame: 3 cycles (21 days each).

    As an early indicator of acute cisplatin induced kidney injury.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada S Elseidy, Master

CONTACT

[email protected]

01124006769 ext. 02

Rana S Fouad, PHD

CONTACT

[email protected]

01208164247 ext. 02

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Potential Renoprotective Effect of Vitamin c and Coenzyme q10 Against Cisplatin Induced Nephrotoxicity in Cancer Patients

Acronym: VitC-CoQ10

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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