Colorectal CancerNCT07391163

Protective Effect of N-acetylcysteine on Oxaliplatin-Induced Neuropathy in Colorectal Cancer

A study testing N-Acetyl Cysteine and Modified FOLFOX-6 regimen in people with Colorectal Cancer, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study investigates the possible protective role of N-Acetylcysteine against oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. The trial aims to evaluate whether N-Acetylcysteine can reduce the incidence and severity of neuropathy during chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: N-Acetyl Cysteine and Modified FOLFOX-6 regimen
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2024to 1 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females aged ≥ 18 years old.
Patients with histologically confirmed diagnosis of Stage III colorectal cancer and high risk Stage II.
Patients who will be scheduled to receive modified FOLFOX-6.
Patients with no contraindication to chemotherapy.
Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5
109/L, platelet count ≥ 100 × 109/L and hemoglobin level ≥ 10 g/dl).

Show all 9Show fewer

Patients with adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance (ClCr) ˃ 45 mL/min).
Patients with adequate liver function (serum bilirubin < 1.5 mg/dl).
Patients with performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG) score.

Who cannot join

Children < 18 years old.
Prior exposure to chemotherapy.
Patients with diabetes and other conditions that predispose to neuropathy.
History of known allergy to oxaliplatin or other platinum agents.
Concomitant use of any drug has anti-oxidant activity or neuroprotective agent.
Patients take any medication that increase acetyle choline either central or peripheral.
Patient was any cardiac disease.
Pregnant and breastfeeding women.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Tanta University - Faculty of Medicine ,oncology department, Tanta university hospital.
Tanta

Other trials in Egypt

About this study

Official title: The Possible Protective Role of N-Acetylcysteine Against Oxaliplatin-Induced Peripheral Neuropathy in Patients With Colorectal Cancer

Read the detailed description

Oxaliplatin, a common chemotherapeutic agent for colorectal cancer, often induces peripheral neuropathy, which can significantly affect patients' quality of life and limit treatment effectiveness. The neuropathy is partly caused by nerve inflammation and oxidative stress.

N-Acetylcysteine (NAC), an antioxidant, has been suggested to protect neurons from oxidative damage and reduce inflammation.

This interventional, randomized, parallel-assignment study will enroll colorectal cancer patients receiving oxaliplatin-based chemotherapy. Participants will be assigned to either receive N-Acetylcysteine alongside chemotherapy or chemotherapy alone. Primary outcomes include the incidence and severity of peripheral neuropathy measured at predefined intervals during treatment.

Secondary outcomes include biochemical markers of nerve inflammation and oxidative stress, including:

Neurotensin (marker of nerve inflammation)
Interleukin-6 (marker of systemic inflammation)
Total Antioxidant Capacity (marker of oxidative stress)

The study aims to provide evidence on whether N-Acetylcysteine can serve as a protective agent against chemotherapy-induced neuropathy, potentially improving treatment tolerance and patient outcomes.

Conditions: Colorectal Cancer
Being tested: Placebo, N-Acetyl Cysteine, Modified FOLFOX-6 regimen
Keywords: Colorectal Cancer, Oxaliplatin, Peripheral Neuropathy, N-Acetylcysteine, Oxaliplatin Induced Peripheral Neuropathy
Medical subject headings: Colorectal Neoplasms, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Oral placebo tablets identical in appearance to N-acetyl cysteine, administered 1 hour before oxaliplatin throughout chemotherapy cycles.
N-Acetyl CysteineDrug
Oral N-acetyl cysteine 1200 mg administered 1 hour before oxaliplatin throughout chemotherapy cycles.
Modified FOLFOX-6 regimenDrug
Oxaliplatin 85 mg/m² IV, leucovorin 400 mg/m² IV, followed by 5-fluorouracil bolus and continuous infusion every 2 weeks.

Study groups in NCT07391163
Study group	Role	What they receive
NAC Group	Experimental	Patients receive modified FOLFOX-6 chemotherapy plus oral N-acetyl cysteine 1200 mg administered 1 hour before oxaliplatin throughout chemotherapy cycles. Receives: Drug: N-Acetyl Cysteine; Drug: Modified FOLFOX-6 regimen
Placebo Group	Placebo comparator	Patients receive modified FOLFOX-6 chemotherapy plus oral placebo tablets administered 1 hour before oxaliplatin throughout chemotherapy cycles. Receives: Drug: Placebo; Drug: Modified FOLFOX-6 regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

NCI-CTCAE, Version 5, 2017
The CTCAE is an international classification system used to assess and describe adverse events resulting from medical treatments, especially in cancer therapy, chemotherapy, and radiation therapy.
It provides standard criteria to grade the severity of each adverse event on a scale from 1 to 5:
Grade 1 (Mild): Mild symptoms, no intervention needed.
Grade 2 (Moderate): Symptoms require minimal intervention or slightly affect daily activities.
Grade 3 (Severe): Symptoms significantly impact daily activities or require medical intervention.
Grade 4 (Life-threatening): Life-threatening symptoms requiring urgent intervention.
Grade 5 (Death): Death due to the adverse event.
Measured: Adverse events will be assessed using NCI-CTCAE v5.0 at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.
FACT/GOG-Ntx-12
The FACT/GOG-Ntx-12 is a patient-reported outcome measure designed to assess chemotherapy-induced neurotoxicity, particularly from drugs such as platinum agents or taxanes.
It consists of 12 items evaluating peripheral neuropathy symptoms, including numbness, tingling, pain, weakness in hands or feet, and difficulty with walking or handling objects.
Each item is scored on a 0-4 scale (0 = not at all, 4 = very much), providing a total score reflecting the severity of neurotoxicity.
It is primarily used to monitor the impact of chemotherapy on neurological function and related quality of life.
Measured: Neurotoxicity-related adverse events will be assessed using the FACT/GOG-Ntx-12 at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.
BPI-SF
The BPI-SF (Brief Pain Inventory - Short Form) is a patient-reported questionnaire used to assess pain severity and its impact on daily functioning.
It includes questions about the intensity of pain (e.g., worst, least, average, and current pain) and how pain interferes with activities such as walking, work, mood, sleep, and relationships.
Each item is rated on a 0-10 numeric scale (0 = no pain / no interference, 10 = worst imaginable pain / complete interference), allowing calculation of overall pain severity and interference scores.
It is widely used in cancer patients and other chronic pain conditions to monitor pain and response to treatment.
Measured: Pain severity and interference will be assessed using the BPI-SF at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.

Secondary outcomes (3)

Serum IL-6 as a marker of inflammation
Serum IL-6 is a pro-inflammatory cytokine commonly used as a biomarker of inflammation.
Elevated IL-6 levels indicate activation of inflammatory pathways, which can occur due to cancer, chemotherapy, or other physiological stressors.
Measurement of serum IL-6 allows monitoring of systemic inflammatory responses in patients undergoing chemotherapy.
Measured: IL-6 will be measured at pre-oxaliplatin infusion (baseline) and after infusion completion (post-dose) on Day 1 of Cycle 1 in both study arms. NAC is administered orally 1 hour before baseline sample in the intervention arm. Each FOLFOX cycle is 14 days.
Serum total anti-oxidant capacity (TAC) as a biomarker of oxidative stress
Serum total antioxidant capacity (TAC) is a biomarker of oxidative stress, reflecting the overall ability of the serum to neutralize free radicals and reactive oxygen species.
TAC is used to evaluate oxidative damage and antioxidant defense mechanisms, which can be affected by chemotherapy.
Measured: TAC will be measured at pre-oxaliplatin infusion (baseline) and after infusion completion (post-dose) on Day 1 of Cycle 1 in both study arms. NAC is administered orally 1 hour before baseline sample in the intervention arm. Each FOLFOX cycle is 14 days.
Serum neurotensin as a biomarker for neuropathy
Description:
Serum neurotensin (NT) is a peptide biomarker used to assess chemotherapy-induced neuropathy.
Changes in serum neurotensin levels correlate with peripheral nerve damage and neurotoxic effects caused by chemotherapeutic agents.
Measured: NT will be measured at pre-oxaliplatin infusion (baseline) and after infusion completion (post-dose) on Day 1 of Cycle 1 in both study arms. NAC is administered orally 1 hour before baseline sample in the intervention arm. Each FOLFOX cycle is 14 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20241 Jan 2026

First posted5 Feb 2026
Study start1 Jan 2024
Primary completion1 Jan 2026
Study completion1 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies 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
Model description: This is a Randomized, placebo-controlled, parallel-group study. Forty-six patients with stage III colorectal cancer and high-risk stage II will be randomly assigned in a 1:1 ratio to one of two arms: Arm 1 (Placebo Group, n=23): Patients will receive 4-6 cycles of modified FOLFOX-6 chemotherapy (Oxaliplatin, Leucovorin, and 5-Fluorouracil) plus oral placebo tablets throughout the chemotherapy cycles. Arm 2 (Drug / Experimental Group, n=23): Patients will receive the same chemotherapy regimen in addition to oral N-Acetyl Cysteine 1200 mg administered 1 hour before Oxaliplatin infusion throughout chemotherapy cycles. Patients will be recruited from the Oncology Department, Tanta University Hospital, Egypt. Randomization will be done using a sealed envelope method. Standard antiemetic and gastric prophylaxis therapy (IV 5-HT3
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07391163
Sponsor's protocol ID: 36264MS490/1/24
Status last verified: Feb 2026
First submitted: 13 Jan 2026
Last updated: 10 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared. This decision is due to patient privacy and confidentiality concerns, as well as the limited resources available for data sharing in this investigator-initiated study.

Publications

Starobova H, Vetter I. Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy. Front Mol Neurosci. 2017 May 31;10:174. doi: 10.3389/fnmol.2017.00174. eCollection 2017.
PubMed 28620280
Tardiolo G, Bramanti P, Mazzon E. Overview on the Effects of N-Acetylcysteine in Neurodegenerative Diseases. Molecules. 2018 Dec 13;23(12):3305. doi: 10.3390/molecules23123305.
PubMed 30551603
Baidoun F, Elshiwy K, Elkeraie Y, Merjaneh Z, Khoudari G, Sarmini MT, Gad M, Al-Husseini M, Saad A. Colorectal Cancer Epidemiology: Recent Trends and Impact on Outcomes. Curr Drug Targets. 2021;22(9):998-1009. doi: 10.2174/1389450121999201117115717.
PubMed 33208072
Tardiolo G, Bramanti P, Mazzon E. Migraine: Experimental Models and Novel Therapeutic Approaches. Int J Mol Sci. 2019 Jun 15;20(12):2932. doi: 10.3390/ijms20122932.
PubMed 31208068
Hegazy ZK, Tawfik SK, Elmashad NM. Protective effect of N-acetylcysteine on oxaliplatin-induced peripheral neuropathy in colorectal cancer: a randomized controlled trial. Cancer Chemother Pharmacol. 2026 Oct 23;96(1):124. doi: 10.1007/s00280-026-04971-0.
PubMed 42909655

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Possible Protective Role of N-Acetylcysteine Against Oxaliplatin-Induced Peripheral Neuropathy in Patients With Colorectal Cancer
ClinicalTrials.gov ID: NCT07391163
Acronym / sponsor ID: 36264MS490/1/24
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer, Oxaliplatin, Peripheral Neuropathy, N-Acetylcysteine, Oxaliplatin Induced Peripheral Neuropathy
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Tanta UniversityUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 1 Jan 2026 (actual)
Study completion: 1 Jan 2026 (actual)
First posted: 5 Feb 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.

Detailed description

N-Acetylcysteine (NAC), an antioxidant, has been suggested to protect neurons from oxidative damage and reduce inflammation.

Secondary outcomes include biochemical markers of nerve inflammation and oxidative stress, including:

Neurotensin (marker of nerve inflammation)
Interleukin-6 (marker of systemic inflammation)
Total Antioxidant Capacity (marker of oxidative stress)

The study aims to provide evidence on whether N-Acetylcysteine can serve as a protective agent against chemotherapy-induced neuropathy, potentially improving treatment tolerance and patient outcomes.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This is a Randomized, placebo-controlled, parallel-group study. Forty-six patients with stage III colorectal cancer and high-risk stage II will be randomly assigned in a 1:1 ratio to one of two arms: Arm 1 (Placebo Group, n=23): Patients will receive 4-6 cycles of modified FOLFOX-6 chemotherapy (Oxaliplatin, Leucovorin, and 5-Fluorouracil) plus oral placebo tablets throughout the chemotherapy cycles. Arm 2 (Drug / Experimental Group, n=23): Patients will receive the same chemotherapy regimen in addition to oral N-Acetyl Cysteine 1200 mg administered 1 hour before Oxaliplatin infusion throughout chemotherapy cycles. Patients will be recruited from the Oncology Department, Tanta University Hospital, Egypt. Randomization will be done using a sealed envelope method. Standard antiemetic and gastric prophylaxis therapy (IV 5-HT3

Arm	Type	Receives
NAC Group	Experimental	Drug: N-Acetyl Cysteine, Drug: Modified FOLFOX-6 regimenPatients receive modified FOLFOX-6 chemotherapy plus oral N-acetyl cysteine 1200 mg administered 1 hour before oxaliplatin throughout chemotherapy cycles.
Placebo Group	Placebo comparator	Drug: Placebo, Drug: Modified FOLFOX-6 regimenPatients receive modified FOLFOX-6 chemotherapy plus oral placebo tablets administered 1 hour before oxaliplatin throughout chemotherapy cycles.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Males and females aged ≥ 18 years old.
Patients with histologically confirmed diagnosis of Stage III colorectal cancer and high risk Stage II.
Patients who will be scheduled to receive modified FOLFOX-6.
Patients with no contraindication to chemotherapy.
Adequate baseline hematologic values (absolute neutrophilic count ≥ 1.5

Key exclusion criteria (8 listed)

Children < 18 years old.
Prior exposure to chemotherapy.
Patients with diabetes and other conditions that predispose to neuropathy.
History of known allergy to oxaliplatin or other platinum agents.
Concomitant use of any drug has anti-oxidant activity or neuroprotective agent.

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
PlaceboOral placebo tablets identical in appearance to N-acetyl cysteine, administered 1 hour before oxaliplatin throughout chemotherapy cycles.	Drug	Placebo Group
N-Acetyl CysteineOral N-acetyl cysteine 1200 mg administered 1 hour before oxaliplatin throughout chemotherapy cycles.	Drug	NAC Group
Modified FOLFOX-6 regimenOxaliplatin 85 mg/m² IV, leucovorin 400 mg/m² IV, followed by 5-fluorouracil bolus and continuous infusion every 2 weeks.	Drug	NAC Group, Placebo Group

Primary outcome

NCI-CTCAE, Version 5, 2017
Time frame: Adverse events will be assessed using NCI-CTCAE v5.0 at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.
The CTCAE is an international classification system used to assess and describe adverse events resulting from medical treatments, especially in cancer therapy, chemotherapy, and radiation therapy. It provides standard criteria to grade the severity of each adverse event on a scale from 1 to 5: Grade 1 (Mild): Mild symptoms, no intervention needed. Grade 2 (Moderate): Symptoms require minimal intervention or slightly affect daily activities. Grade 3 (Severe): Symptoms significantly impact daily activities or require medical intervention. Grade 4 (Life-threatening): Life-threatening symptoms requiring urgent intervention. Grade 5 (Death): Death due to the adverse event.
FACT/GOG-Ntx-12
Time frame: Neurotoxicity-related adverse events will be assessed using the FACT/GOG-Ntx-12 at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.
The FACT/GOG-Ntx-12 is a patient-reported outcome measure designed to assess chemotherapy-induced neurotoxicity, particularly from drugs such as platinum agents or taxanes. It consists of 12 items evaluating peripheral neuropathy symptoms, including numbness, tingling, pain, weakness in hands or feet, and difficulty with walking or handling objects. Each item is scored on a 0-4 scale (0 = not at all, 4 = very much), providing a total score reflecting the severity of neurotoxicity. It is primarily used to monitor the impact of chemotherapy on neurological function and related quality of life.
BPI-SF
Time frame: Pain severity and interference will be assessed using the BPI-SF at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.
The BPI-SF (Brief Pain Inventory - Short Form) is a patient-reported questionnaire used to assess pain severity and its impact on daily functioning. It includes questions about the intensity of pain (e.g., worst, least, average, and current pain) and how pain interferes with activities such as walking, work, mood, sleep, and relationships. Each item is rated on a 0-10 numeric scale (0 = no pain / no interference, 10 = worst imaginable pain / complete interference), allowing calculation of overall pain severity and interference scores. It is widely used in cancer patients and other chronic pain conditions to monitor pain and response to treatment.

3 secondary outcomes

Serum IL-6 as a marker of inflammation
Time frame: IL-6 will be measured at pre-oxaliplatin infusion (baseline) and after infusion completion (post-dose) on Day 1 of Cycle 1 in both study arms. NAC is administered orally 1 hour before baseline sample in the intervention arm. Each FOLFOX cycle is 14 days.
Serum total anti-oxidant capacity (TAC) as a biomarker of oxidative stress
Time frame: TAC will be measured at pre-oxaliplatin infusion (baseline) and after infusion completion (post-dose) on Day 1 of Cycle 1 in both study arms. NAC is administered orally 1 hour before baseline sample in the intervention arm. Each FOLFOX cycle is 14 days.
Serum neurotensin as a biomarker for neuropathy
Time frame: NT will be measured at pre-oxaliplatin infusion (baseline) and after infusion completion (post-dose) on Day 1 of Cycle 1 in both study arms. NAC is administered orally 1 hour before baseline sample in the intervention arm. Each FOLFOX cycle is 14 days.

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 10 Feb 2026.
Background: PubMed 28620280Starobova H, Vetter I. Pathophysiology of Chemotherapy-Induced Peripheral Neuropathy. Front Mol Neurosci. 2017 May 31;10:174. doi: 10.3389/fnmol.2017.00174. eCollection 2017.
Background: PubMed 30551603Tardiolo G, Bramanti P, Mazzon E. Overview on the Effects of N-Acetylcysteine in Neurodegenerative Diseases. Molecules. 2018 Dec 13;23(12):3305. doi: 10.3390/molecules23123305.
Background: PubMed 33208072Baidoun F, Elshiwy K, Elkeraie Y, Merjaneh Z, Khoudari G, Sarmini MT, Gad M, Al-Husseini M, Saad A. Colorectal Cancer Epidemiology: Recent Trends and Impact on Outcomes. Curr Drug Targets. 2021;22(9):998-1009. doi: 10.2174/1389450121999201117115717.
Background: PubMed 31208068Tardiolo G, Bramanti P, Mazzon E. Migraine: Experimental Models and Novel Therapeutic Approaches. Int J Mol Sci. 2019 Jun 15;20(12):2932. doi: 10.3390/ijms20122932.
Derived from this study: PubMed 42909655Hegazy ZK, Tawfik SK, Elmashad NM. Protective effect of N-acetylcysteine on oxaliplatin-induced peripheral neuropathy in colorectal cancer: a randomized controlled trial. Cancer Chemother Pharmacol. 2026 Oct 23;96(1):124. doi: 10.1007/s00280-026-04971-0.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This decision is due to patient privacy and confidentiality concerns, as well as the limited resources available for data sharing in this investigator-initiated study.

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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. This study is not recruiting at the moment.

Nehal Mohamed Elmashad, Professor principal investigator

Department of Clinical Oncology ,Tanta University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing N-Acetyl Cysteine and Modified FOLFOX-6 regimen in people with Colorectal Cancer, 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 9 inclusion and 8 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 10 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. Some participants in this study may receive a placebo. 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?

NCI-CTCAE, Version 5, 2017 (time frame: Adverse events will be assessed using NCI-CTCAE v5.0 at baseline (Day 1, prior to Cycle 1) and after Cycle 2 (Day 15) and after Cycle 4 (Day 29). Each chemotherapy cycle lasts 14 days.). The study lists 3 primary outcomes in all. 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 NCT07391163, which also lists 5 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 10 Feb 2026.