Cisplatin NephrotoxicityPhase 2NCT07564479
Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
A Phase 2 study testing Alpha-Lipoic Acid (ALA) in people with Cisplatin Nephrotoxicity and Nephrotoxicity, run by Minia University at 1 site in Egypt.
Trial summary
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cisplatin Nephrotoxicity, Nephrotoxicity
- What is being tested?
- Alpha-Lipoic Acid (ALA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2026to Jun 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years. Histologically confirmed solid malignancy. Planned treatment with cisplatin starting from a dose of 60 mg/m2 per cycle (21-28 days each or fractionated).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Baseline serum creatinine within normal range or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2.
- Ability to provide informed consent.
Who cannot join
- Pre existing renal impairment (eGFR < 60〖" mL/min/1.73 m" 〗^2or serum creatinine > 1.5 × upper limit of normal).
- Concomitant use of known nephrotoxic drugs that cannot be stopped (e.g., aminoglycosides, amphotericin B, high dose NSAIDs).
- Uncontrolled hypertension, decompensated heart failure, or severe hepatic impairment.
- Known allergy or intolerance to ALA. Pregnancy or lactation. Participation in another interventional clinical trial.
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, 1 recruiting
- Recruiting
Minia University Hospital
Minya, Minya Governorate, 61111
Ahmed Mostafa Abd-Elaziz, +20 10 09144024, dr_ahmad2012@yahoo.com
asmaa.bashandy@mu.edu.eg
About this study
Official title: Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
Read the detailed description
This proof-of-concept study will be a randomized, controlled, open label clinical trial with parallel group assignment, designed to evaluate the nephroprotective effect of alpha lipoic acid (ALA) in patients receiving cisplatin based chemotherapy.
- Allocation: Randomized (1:1).
- Interventional model: Parallel assignment.
- Masking: None (open label).
- Conditions
- Cisplatin Nephrotoxicity, Nephrotoxicity
- Being tested
- Alpha-Lipoic Acid (ALA)
- Keywords
- Cisplatin, Nephrotoxicity, ALA, Alpha-Lipoic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Lipoic Acid (ALA)Drug
The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Hydration | No intervention | o Standard preventive measures for cisplatin nephrotoxicity (e.g., pre and post hydration, antiemetics, magnesium and potassium supplementation as per unit protocol) will be applied. |
| Alpha Lipoic Acid + Standard Hydration | Experimental | * Patients will receive the same cisplatin based chemotherapy regimens and standard preventive measures as the control group.
* In addition, they will receive oral alpha lipoic acid at a dose of [e.g., 600 mg] twice daily (ALA [brand/formulation], [manufacturer, country]) starting [e.g., 2 days] before the first cisplatin dose and continued throughout each chemotherapy cycle until 2 days after the last cisplatin administration in that cycle, for a total of 4 cycles Receives: Drug: Alpha-Lipoic Acid (ALA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group
Measuring the change in Scr and CrCl in patients before and after they have a cumulative dose of 200mg/m2, depending on each patient's dosage regimen
Measured: Baseline, weekly up to 6 weeks
Secondary outcomes (3)
Patients' Quality of Life
We will measure the patients' quality of life using the Arabic version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) questionnaire
Measured: Baseline; and end of study (Up to 6 weeks)
Incidence of AKI ain patients receiving cisplatin
AKI is defined as o An increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 1.5 times baseline within 7 days; or
- A decrease in eGFR ≥ 25% from baseline; according to KDIGO acute kidney injury criteria.
Measured: From cisplatin initiation through end of study (Up to 6 weeks)
Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity
Measured: From cisplatin initiation through end of study (Up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cisplatin NephrotoxicityStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University Hospital
- Responsible party
- Principal investigator, Asmaa Bassem Mohammed, Minia University
- Investigators
- Ahmed Mostafa Abd-Elaziz, Study director, Department of Clinical Oncology, Faculty of Medicine, Minia UniversityAmal Kamal Hussein, Study chair, Faculty of Pharmacy, Minia UniversityEman Mohamed Sadek, Study director, Faculty of Pharmacy, Minia UniversityAsmaa Basem Mohammed, Principal investigator, Faculty of Pharmacy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564479
- Sponsor's protocol ID
- MPEC(260305)
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of participants as the sample size is small and in one location
Publications
Kim KH, Lee B, Kim YR, Kim MA, Ryu N, Jung DJ, Kim UK, Baek JI, Lee KY. Evaluating protective and therapeutic effects of alpha-lipoic acid on cisplatin-induced ototoxicity. Cell Death Dis. 2018 Aug 1;9(8):827. doi: 10.1038/s41419-018-0888-z.
PubMed 30068942Fayez AM, Zakaria S, Moustafa D. Alpha lipoic acid exerts antioxidant effect via Nrf2/HO-1 pathway activation and suppresses hepatic stellate cells activation induced by methotrexate in rats. Biomed Pharmacother. 2018 Sep;105:428-433. doi: 10.1016/j.biopha.2018.05.145. Epub 2018 Jun 5.
PubMed 29879626Derosa G, D'Angelo A, Preti P, Maffioli P. Safety and Efficacy of Alpha Lipoic Acid During 4 Years of Observation: A Retrospective, Clinical Trial in Healthy Subjects in Primary Prevention. Drug Des Devel Ther. 2020 Dec 3;14:5367-5374. doi: 10.2147/DDDT.S280802. eCollection 2020.
PubMed 33299302Rajeswaran A, Trojan A, Burnand B, Giannelli M. Efficacy and side effects of cisplatin- and carboplatin-based doublet chemotherapeutic regimens versus non-platinum-based doublet chemotherapeutic regimens as first line treatment of metastatic non-small cell lung carcinoma: a systematic review of randomized controlled trials. Lung Cancer. 2008 Jan;59(1):1-11. doi: 10.1016/j.lungcan.2007.07.012. Epub 2007 Aug 27.
PubMed 17720276
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity in Oncology Patients
- ClinicalTrials.gov ID
- NCT07564479
- Acronym / sponsor ID
- MPEC(260305)
- Conditions
- Cisplatin Nephrotoxicity, Nephrotoxicity
- Keywords
- Cisplatin, Nephrotoxicity, ALA, Alpha-Lipoic Acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Collaborators
- Minia University Hospital
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 May 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.
To assess the nephroprotective efficacy of Alpha-Lipoic Acid in preventing cisplatin-induced nephrotoxicity in oncology patients by monitoring renal function changes
Detailed description
This proof-of-concept study will be a randomized, controlled, open label clinical trial with parallel group assignment, designed to evaluate the nephroprotective effect of alpha lipoic acid (ALA) in patients receiving cisplatin based chemotherapy.
- Allocation: Randomized (1:1).
- Interventional model: Parallel assignment.
- Masking: None (open label).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Hydration | No intervention | –o Standard preventive measures for cisplatin nephrotoxicity (e.g., pre and post hydration, antiemetics, magnesium and potassium supplementation as per unit protocol) will be applied. |
| Alpha Lipoic Acid + Standard Hydration | Experimental | Drug: Alpha-Lipoic Acid (ALA)* Patients will receive the same cisplatin based chemotherapy regimens and standard preventive measures as the control group. * In addition, they will receive oral alpha lipoic acid at a dose of [e.g., 600 mg] twice daily (ALA [brand/formulation], [manufacturer, country]) starting [e.g., 2 days] before the first cisplatin dose and continued throughout each chemotherapy cycle until 2 days after the last cisplatin administration in that cycle, for a total of 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years. Histologically confirmed solid malignancy. Planned treatment with cisplatin starting from a dose of 60 mg/m2 per cycle (21-28 days each or fractionated).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Baseline serum creatinine within normal range or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2.
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- Pre existing renal impairment (eGFR < 60〖" mL/min/1.73 m" 〗^2or serum creatinine > 1.5 × upper limit of normal).
- Concomitant use of known nephrotoxic drugs that cannot be stopped (e.g., aminoglycosides, amphotericin B, high dose NSAIDs).
- Uncontrolled hypertension, decompensated heart failure, or severe hepatic impairment.
- Known allergy or intolerance to ALA. Pregnancy or lactation. Participation in another interventional clinical trial.
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 |
|---|---|---|
| Alpha-Lipoic Acid (ALA)The intervention under investigation is the administration of oral Alpha-Lipoic Acid (ALA) as an adjunct to standard cisplatin-based chemotherapy. | Drug | Alpha Lipoic Acid + Standard Hydration |
Primary outcome
Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group
Time frame: Baseline, weekly up to 6 weeks
Measuring the change in Scr and CrCl in patients before and after they have a cumulative dose of 200mg/m2, depending on each patient's dosage regimen
3 secondary outcomes
Patients' Quality of Life
Time frame: Baseline; and end of study (Up to 6 weeks)
Incidence of AKI ain patients receiving cisplatin
Time frame: From cisplatin initiation through end of study (Up to 6 weeks)
Incidence of cisplatin dose reduction, delay, or discontinuation due to nephrotoxicity
Time frame: From cisplatin initiation through end of study (Up to 6 weeks)
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 4 May 2026.
- Background: PubMed 30068942Kim KH, Lee B, Kim YR, Kim MA, Ryu N, Jung DJ, Kim UK, Baek JI, Lee KY. Evaluating protective and therapeutic effects of alpha-lipoic acid on cisplatin-induced ototoxicity. Cell Death Dis. 2018 Aug 1;9(8):827. doi: 10.1038/s41419-018-0888-z.
- Background: PubMed 29879626Fayez AM, Zakaria S, Moustafa D. Alpha lipoic acid exerts antioxidant effect via Nrf2/HO-1 pathway activation and suppresses hepatic stellate cells activation induced by methotrexate in rats. Biomed Pharmacother. 2018 Sep;105:428-433. doi: 10.1016/j.biopha.2018.05.145. Epub 2018 Jun 5.
- Background: PubMed 33299302Derosa G, D'Angelo A, Preti P, Maffioli P. Safety and Efficacy of Alpha Lipoic Acid During 4 Years of Observation: A Retrospective, Clinical Trial in Healthy Subjects in Primary Prevention. Drug Des Devel Ther. 2020 Dec 3;14:5367-5374. doi: 10.2147/DDDT.S280802. eCollection 2020.
- Background: PubMed 17720276Rajeswaran A, Trojan A, Burnand B, Giannelli M. Efficacy and side effects of cisplatin- and carboplatin-based doublet chemotherapeutic regimens versus non-platinum-based doublet chemotherapeutic regimens as first line treatment of metastatic non-small cell lung carcinoma: a systematic review of randomized controlled trials. Lung Cancer. 2008 Jan;59(1):1-11. doi: 10.1016/j.lungcan.2007.07.012. Epub 2007 Aug 27.
- Individual participant dataSharing planned: No. To protect the privacy of participants as the sample size is small and in one location
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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.
Ahmed Mostafa Abd-Elaziz study director
Department of Clinical Oncology, Faculty of Medicine, Minia University
Amal Kamal Hussein study chair
Faculty of Pharmacy, Minia University
Eman Mohamed Sadek study director
Faculty of Pharmacy, Minia 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 study testing Alpha-Lipoic Acid (ALA) in people with Cisplatin Nephrotoxicity and Nephrotoxicity, run by Minia 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 3 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: looking for participants now, as of the sponsor's last update on 4 May 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 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.
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 Asmaa Mohammed (00201090824147, asmaa.bashandy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SCr and CrCl in patients receiving Cisplatin Chemotherapy + Alpha-Lipoic Acid compared to Control Group (time frame: Baseline, weekly up to 6 weeks). 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 NCT07564479, which also lists 4 linked publications.
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 4 May 2026.