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
01067366826 ext. 02
NCT Number: NCT07476443
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Cairo, Shoubra, 11617, Egypt
Mohammed H
CONTACT
01002406744 ext. 02
Rasha M AbdelMotagalee, Consultant
PRINCIPAL_INVESTIGATOR
Rasha M AbdelMotagalee, Senior
CONTACT
01067366826 ext. 02
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vitamin C 500 mg administered orally
Other names: Ascorbic acid
30 mg administered orally
Other names: CoQ10
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
Time frame: 3 cycles (21 days each).
As an early indicator of acute cisplatin induced kidney injury.
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
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
The Potential Renoprotective Effect of Vitamin c and Coenzyme q10 Against Cisplatin Induced Nephrotoxicity in Cancer Patients
Acronym: VitC-CoQ10
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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