Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity

NCT07476443 | Not Yet Recruiting Phase 2

• 1 other identifier: 2020110301
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nephrotoxicity

Keywords

Cisplatin; Vitamin C; CoQ10; cancer; nephrotoxicity; KIM-1

Outcome Measures

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

  3 cycles (21 days each).

Secondary Outcomes (2)

• KIM-1 biomarker levels

  3 cycles (21 days each).

• Assesment of the quality of life

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

Study Arms (3)

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 ).

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 ).

Drug: Coenzyme Q 10

Interventions

Vitamin C DRUG

Vitamin C 500 mg administered orally

Also known as: Ascorbic acid

Vit C

Coenzyme Q 10 DRUG

30 mg administered orally

Also known as: CoQ10

CoQ10

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Nasser Institute for Research and Treatment

Cairo, Shoubra, 11617, Egypt

Location

Related Publications (1)

• 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.

  PMID: 28197460 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Ascorbic Acid; coenzyme Q10

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Nagwa A Sabri, PHD

  Professor of Clinical Pharmacy-Faculty of Pharmacy-Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada S Elseidy, Master

CONTACT

01124006769; ghada.ms2324013@pharma.asu.edu.eg

Rana S Fouad, PHD

CONTACT

01208164247; ranasayed@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: March 17, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)