Peripheral Neuropathy Due to ChemotherapyPhase 2NCT06135493
Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
A Phase 2 study testing Losartan in people with Peripheral Neuropathy Due to Chemotherapy, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2023to 30 Mar 2025
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2.
Who cannot join
- Known hypersensitivity to Losartan.
- Not Known Hypertensive patients
- Not Known Diabetic patients
- Treatment with Losartan/ARBs/ACE-I prior to the study.
- Previous neuropathy
- Renal impairment (Serum creatinine > 2 mg/dl)
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- Significant liver disease: liver enzymes 2 folds the upper normal limit
- Metastatic breast cancer
- Pregnancy or lactation
- Taking other medication for neuropathic pain
- Significant Hypotension
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Breast Cancer Comprehensive Center of the National Cancer Institute, Cairo University
Cairo
About this study
Official title: Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.
Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect.
The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.
- Being tested
- Losartan
- Keywords
- Paclitaxel, Breast Cancer, Peripheral Neuropathy
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Using losartan to prevent paclitaxel-induced peripheral neuropathy
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting |
| Intervention arm | Experimental | These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of paclitaxel-induced peripheral neuropathy
Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)
Measured: 12 weeks
Secondary outcomes (3)
Patient QOL
Patient quality of life will be assessed by Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)
Measured: 12 weeks
Pain Severity
Pain intensity will be assessed through Visaul Analogue Scale Scale 0-10
Measured: 12 Weeks
Serum biomarker
Level of Nerve growth factor (NGF) in Serum
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start12 Dec 2023
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mahmoud Ahmed Shawqy Mahmoud, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135493
- Sponsor's protocol ID
- REC-FPFUE-30/2023
- Status last verified
- Apr 2025
- First submitted
- 11 Nov 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahmoud AMAS, Shash E, Ateyya H, Okasha FA, El Said NO. The Effect of Losartan in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study. Pharmacotherapy. 2026 Apr;46(4):e70124. doi: 10.1002/phar.70124.
PubMed 41800821
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Losartan in the Prevention of Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT06135493
- Acronym / sponsor ID
- REC-FPFUE-30/2023
- Keywords
- Paclitaxel, Breast Cancer, Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 18 Nov 2023 (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.
Paclitaxel-induced peripheral neuropathy (PIPN) is one of the most dose-limiting side effects; it causes patients discomfort and pain and sometimes causes the termination of the chemotherapy cycles, leading to treatment failure. A lot of interventions have been tried to prevent PIPN, ensure complete administration of the chemotherapy cycles, and increase the survival rate. One of the promising interventions in the prevention of PIPN is Losartan. Losartan is an angiotensin receptor blocker (ARBs) and is used to treat hypertensive patients. There is strong evidence from different preclinical studies and retrospective cohort studies that Losartan has a neuroprotective effect.
The purpose of our study is to investigate the efficacy of Losartan in the prevention of peripheral neuropathy associated with Paclitaxel treatment in Breast Cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –These patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting |
| Intervention arm | Experimental | Drug: LosartanThese patients will receive standard-of-care management for chemotherapy-induced nausea and vomiting plus losartan 100mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females older than 18 years diagnosed with biopsy-confirmed breast cancer (Early breast cancer eligible for adjuvant or neoadjuvant) who are scheduled to receive paclitaxel 80 mg/m2.
Key exclusion criteria (11 listed)
- Known hypersensitivity to Losartan.
- Not Known Hypertensive patients
- Not Known Diabetic patients
- Treatment with Losartan/ARBs/ACE-I prior to the study.
- Previous neuropathy
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 |
|---|---|---|
| LosartanUsing losartan to prevent paclitaxel-induced peripheral neuropathy | Drug | Intervention arm |
Primary outcome
Development of paclitaxel-induced peripheral neuropathy
Time frame: 12 weeks
Incidence and grading of paclitaxel-induced peripheral neuropathy (PIPN)
3 secondary outcomes
Patient QOL
Time frame: 12 weeks
Pain Severity
Time frame: 12 Weeks
Serum biomarker
Time frame: 12 weeks
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 24 Apr 2025.
- Derived from this study: PubMed 41800821Mahmoud AMAS, Shash E, Ateyya H, Okasha FA, El Said NO. The Effect of Losartan in Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer: A Randomized, Controlled Study. Pharmacotherapy. 2026 Apr;46(4):e70124. doi: 10.1002/phar.70124.
- Individual participant dataSharing planned: No
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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.
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 Phase 2 study testing Losartan in people with Peripheral Neuropathy Due to Chemotherapy, run by Future University in Egypt 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 1 inclusion and 11 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 24 Apr 2025. 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?
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?
Development of paclitaxel-induced peripheral neuropathy (time frame: 12 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 NCT06135493, which also lists 1 linked publication.
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 24 Apr 2025.