Pentoxifylline, Cisplatin, NephrotoxixcityNCT05640817
Nephroprotective Effect of Pentoxifylline Against Cisplatin in Patients With Head and Neck Cancer
A study testing Pentoxifylline 400 mg SR tablets and cisplatin with standard hydration with normal saline in people with Pentoxifylline, Cisplatin, Nephrotoxixcity, run by Tanta University at 1 site in Egypt.
Trial summary
Head and neck squamous cell carcinoma (HNSCC) encompasses a variety of tumors originating in the lip, oral cavity, hypopharynx, oropharynx, nasopharynx and larynx. It is the sixth most common malignancy worldwide accounting for approximately 6% of all cancer cases (Rettig and D'Souza., 2015). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pentoxifylline, Cisplatin, Nephrotoxixcity
- What is being tested?
- Pentoxifylline 400 mg SR tablets and cisplatin with standard hydration with normal saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2023to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 years or more with head and neck cancer who will receive cisplatin for the first time.
- Baseline estimated glomerular filtration rate (eGFR) ≥ 59 ml/min/1.73 m2.
- Eastern Cooperative Oncology Group performance status (ECOG) < 2.
- Patients with normal organic function as defined for the following criteria:
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory ;
- Total serum bilirubin ≤ 2.0 x ULN-LL;
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- Absolute neutrophil count ≥ 1,500 / mm3;
- Platelet count ≥ 100,000 / mm3;
- Hemoglobin ≥ 8.0 g / dl;
- Serum creatinine ≤ 1.5 x ULN-LL
Who cannot join
- Pregnant or nursing women, or females intending pregnancy were all prohibited
- Patients with concurrent other malignancy or history of other malignancy treated within the past 3 years.
- Baseline estimated glomerular filtration rate (eGFR) < 59 ml/min/1.73 m2.
- Alanine aminotransferase (ALT) > 3× times ULN.
- Eastern Cooperative Oncology Group performance status (ECOG) ≥2.
- Patients have Diabetes mellitus.
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- Patients have current participation in other protocols with experimental drugs.
- Patients with no ability to ingest food orally.
- Pentoxifylline hypersensitivity.
- Use of other nephrotoxic drugs as aminoglycosides, non-steroidal anti-inflammatory drugs and contrast media.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating the Nephroprotective Effect of Pentoxifylline Against Cisplatin in Patients With Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) encompasses a variety of tumors originating in the lip, oral cavity, hypopharynx, oropharynx, nasopharynx and larynx. It is the sixth most common malignancy worldwide accounting for approximately 6% of all cancer cases (Rettig and D'Souza., 2015). HNSCC represents the third most common cause of cancer death worldwide. Platinum based regimens represent cornerstone in its treatment (Galbiattiet al., 2013).
Cisplatin (cis-diammine dichloroplatinum (II), CDDP) is an inorganic platinum-based chemotherapeutic agent that is widely used in treatment of various solid malignancies as head and neck, lung, testis, ovarian, and bladder cancers (Aparecida et al., 2012). The use of cisplatin is frequently limited by significant side effects including bone marrow suppression, peripheral neuropathy, ototoxicity, anaphylaxis and nephrotoxicity with the latter representing the main dose limiting one (Aparecida et al., 2012).
Read more
Acute kidney injury (AKI), distal renal tubular acidosis, renal concentrating defect, transient proteinuria, hyperuricemia, Fanconi-like syndrome, hypomagnesemia, hypocalcemia, renal salt wasting, erythropoietin deficiency, thrombotic microangiopathy, and chronic renal failure are among the renal side effects of cisplatin (Miller et al., 2010).Renal function deterioration is seen in 25% to 35% of patients treated with a single dose of cisplatin (Miller et al., 2010).Cisplatin-induced injury to renal epithelial cells results in the production of various inflammatory factors, including TNF-α. Cisplatin also increases ROS production, which leads to the activation of apoptosis and necrosis pathways (Miller et al., 2010).
Pentoxifylline (PTX), a nonspecific phosphodiesterase inhibitor, was first considered in the treatment of peripheral vascular diseases (Nasiri-Toosi et al., 2013). PTX has anti-inflammatory effects as it down regulates several pro-inflammatory cytokines, including tumor necrosis factor alpha (TNF-α) and interleukin-1 (IL-1) and IL-6 (Mostafa-Hedeab et al., 2022). In addition, PTX has gained considerable interest as a reactive oxygen species (ROS) scavenger, and several studies show its potential antioxidant effects (Zhang et al., 2016). Several studies evaluate the renoprotective effects of PTX against drug-induced nephrotoxicity (Ramesh and Reeves, 2002; Kasap et al., 2013;Nasiri-Toosi et al.,2013; Panahi-Shokouh etal., 2020; Alorabi et al., 2022).
- Being tested
- Pentoxifylline 400 mg SR tablets, cisplatin with standard hydration with normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline 400 mg SR tabletsDrug
a nonspecific phosphodiesterase inhibitor, was first considered in the treatment of peripheral vascular diseases
cisplatin with standard hydration with normal salineDrug
chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 as control group | Active comparator | cisplatin with standard hydration with normal saline Receives: Drug: cisplatin with standard hydration with normal saline |
| Group two as Pentoxifylline | Active comparator | receive cisplatin with standard hydration with normal saline and Pentoxifylline 400 mg SR tablets twice daily for three cycles. Receives: Drug: Pentoxifylline 400 mg SR tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
nephrotoxicity improvement as measured by CTACE version 5.0
Measured: up to 6 months
Secondary outcomes (1)
Kidney injury molecule 1 decrease serum level
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start10 Jan 2023
- Primary completion20 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pentoxifylline, Cisplatin, NephrotoxixcityStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Elberri, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640817
- Sponsor's protocol ID
- PTX122022
- Status last verified
- Feb 2026
- First submitted
- 30 Nov 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Nephroprotective Effect of Pentoxifylline Against Cisplatin in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05640817
- Acronym / sponsor ID
- PTX122022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 7 Dec 2022 (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.
Head and neck squamous cell carcinoma (HNSCC) encompasses a variety of tumors originating in the lip, oral cavity, hypopharynx, oropharynx, nasopharynx and larynx. It is the sixth most common malignancy worldwide accounting for approximately 6% of all cancer cases (Rettig and D'Souza., 2015). HNSCC represents the third most common cause of cancer death worldwide. Platinum based regimens represent cornerstone in its treatment (Galbiattiet al., 2013).
Cisplatin (cis-diammine dichloroplatinum (II), CDDP) is an inorganic platinum-based chemotherapeutic agent that is widely used in treatment of various solid malignancies as head and neck, lung, testis, ovarian, and bladder cancers (Aparecida et al., 2012). The use of cisplatin is frequently limited by significant side effects including bone marrow suppression, peripheral neuropathy, ototoxicity, anaphylaxis and nephrotoxicity with the latter representing the main dose limiting one (Aparecida et al., 2012).
Acute kidney injury (AKI), distal renal tubular acidosis, renal concentrating defect, transient proteinuria, hyperuricemia, Fanconi-like syndrome, hypomagnesemia, hypocalcemia, renal salt wasting, erythropoietin deficiency, thrombotic microangiopathy, and chronic renal failure are among the renal side effects of cisplatin (Miller et al., 2010).Renal function deterioration is seen in 25% to 35% of patients treated with a single dose of cisplatin (Miller et al., 2010).Cisplatin-induced injury to renal epithelial cells results in the production of various inflammatory factors, including TNF-α. Cisplatin also increases ROS production, which leads to the activation of apoptosis and necrosis pathways (Miller et al., 2010).
Pentoxifylline (PTX), a nonspecific phosphodiesterase inhibitor, was first considered in the treatment of peripheral vascular diseases (Nasiri-Toosi et al., 2013). PTX has anti-inflammatory effects as it down regulates several pro-inflammatory cytokines, including tumor necrosis factor alpha (TNF-α) and interleukin-1 (IL-1) and IL-6 (Mostafa-Hedeab et al., 2022). In addition, PTX has gained considerable interest as a reactive oxygen species (ROS) scavenger, and several studies show its potential antioxidant effects (Zhang et al., 2016). Several studies evaluate the renoprotective effects of PTX against drug-induced nephrotoxicity (Ramesh and Reeves, 2002; Kasap et al., 2013;Nasiri-Toosi et al.,2013; Panahi-Shokouh etal., 2020; Alorabi et al., 2022).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 as control group | Active comparator | Drug: cisplatin with standard hydration with normal salinecisplatin with standard hydration with normal saline |
| Group two as Pentoxifylline | Active comparator | Drug: Pentoxifylline 400 mg SR tabletsreceive cisplatin with standard hydration with normal saline and Pentoxifylline 400 mg SR tablets twice daily for three cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient aged 18 years or more with head and neck cancer who will receive cisplatin for the first time.
- Baseline estimated glomerular filtration rate (eGFR) ≥ 59 ml/min/1.73 m2.
- Eastern Cooperative Oncology Group performance status (ECOG) < 2.
- Patients with normal organic function as defined for the following criteria:
Key exclusion criteria (10 listed)
- Pregnant or nursing women, or females intending pregnancy were all prohibited
- Patients with concurrent other malignancy or history of other malignancy treated within the past 3 years.
- Baseline estimated glomerular filtration rate (eGFR) < 59 ml/min/1.73 m2.
- Alanine aminotransferase (ALT) > 3× times ULN.
- Eastern Cooperative Oncology Group performance status (ECOG) ≥2.
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 |
|---|---|---|
| Pentoxifylline 400 mg SR tabletsa nonspecific phosphodiesterase inhibitor, was first considered in the treatment of peripheral vascular diseases | Drug | Group two as Pentoxifylline |
| cisplatin with standard hydration with normal salinechemotherapy | Drug | Group 1 as control group |
Primary outcome
nephrotoxicity improvement as measured by CTACE version 5.0
Time frame: up to 6 months
1 secondary outcome
Kidney injury molecule 1 decrease serum level
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline 400 mg SR tablets and cisplatin with standard hydration with normal saline in people with Pentoxifylline, Cisplatin, Nephrotoxixcity, run by Tanta 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 6 Feb 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nephrotoxicity improvement as measured by CTACE version 5.0 (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2026.