Breast Cancer FemalePhase 2/3NCT05189535
"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
A Phase 2/3 study testing Pentoxifylline and Paclitaxel in people with Breast Cancer Female and Peripheral Neuropathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female, Peripheral Neuropathy
- What is being tested?
- Pentoxifylline and Paclitaxel
- 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
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2021to 28 Sep 2023
- Phase
- Phase 2/3
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18-80 years old).
- Female patients.
- Pathologically proved breast cancer.
- Breast cancer patients who will receive adjuvant and neoadjuvant weekly paclitaxel for 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance ≤ 2
- Adequate bone marrow function.
- Adequate liver and kidney function.
Who cannot join
- Patients with preexisting clinical neuropathy.
- Patients with diabetes mellitus.
- Metastatic breast cancer.
- Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics.
- Patients treated with medications that increase the risk of neuropathy.
- Hypersensitivity to pentoxifylline or xanthine derivatives.
- Patients with recent (within 1 month) surgery, myocardial infarction (MI), intracranial or retinal bleeding or active peptic ulcer.
- Patients at high risk for bleeding or taking medications that increase risk of bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Evaluation of the Effect of Pentoxifylline on the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.
Read the detailed description
Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include pain, tingling, cold-sensitivity and numbness that typically presents in a stocking glove distribution. The pathogenesis of PIPN may be attributed to drug accumulation in dorsal root ganglia causing increase in inflammatory cytokines, immune mediators and dysregulation of calcium subunits which in turn increases pain. It also causes oxidative stress in sensory axons leading to axon demyelination, increased sensitization to signal transduction, release of pro-inflammatory mediators and activation of apoptosis.
Many animal studies and clinical trials have shown pentoxifylline to have a significant anti-inflammatory and antioxidant effect. It also preserved nerve conduction velocity and ameliorated mechanical hyperalgesia. Pentoxifylline showed a prominent reduction in neuropathic pain in diabetic patients. These effects were mainly due to the ability of pentoxifylline to reduce TNF-α and MDA levels. So, pentoxifylline is a drug of interest due to its ability to ameliorate neuro-inflammation and oxidative stress which play a critical role in PIPN pathogenesis.
- Conditions
- Breast Cancer Female, Peripheral Neuropathy
- Being tested
- Pentoxifylline, Paclitaxel, Placebo
- Keywords
- Breast cancer, pentoxifylline, paclitaxel, Taxol, peripheral neuropathy, Trental
- Medical subject headings
- Peripheral Nervous System Diseases, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called Trental
Pentoxifylline 400 mg oral tablet twice daily for 12 weeks.
PaclitaxelDrug
Also called Taxol
Paclitaxel I.V 80 mg/m2 weekly
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| pentoxifylline 400 mg | Experimental | Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and pentoxifylline 400 mg twice daily for the paclitaxel treatment period. Receives: Drug: Pentoxifylline; Drug: Paclitaxel |
| Placebo | Placebo comparator | Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and placebo twice daily for the paclitaxel treatment period.. Receives: Drug: Paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Paclitaxel induced-peripheral neuropathy
Number of patients reported neuropathy due to paclitaxel
Measured: 12 weeks
Secondary outcomes (3)
Grade of severity of Paclitaxel induced-peripheral neuropathy in patients who developed neuropathy
Severity of neuropathic symptoms will be graded using Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)
Measured: at baseline and on weekly bases for 12 weeks
Evaluation of Safety and tolerability of pentoxifylline
side effects reported due to pentoxifylline will be recorded.
Measured: evaluation on weekly bases for 12 weeks.
The need for dose reduction or drug discontinuation in pentoxifylline and placebo arm.
number of patients who needed dose reduction or drug discontinuation due to paclitaxel induced neuropathy will be recorded.
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 posted12 Jan 2022
- Study start3 Oct 2021
- Primary completion18 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, placebo controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sondos Sherif Ismail, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189535
- Sponsor's protocol ID
- s2192648
- Status last verified
- Jan 2024
- First submitted
- 4 Oct 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of the Effect of Pentoxifylline on the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"
- ClinicalTrials.gov ID
- NCT05189535
- Acronym / sponsor ID
- s2192648
- Conditions
- Breast Cancer Female, Peripheral Neuropathy
- Keywords
- Breast cancer, pentoxifylline, paclitaxel, Taxol, peripheral neuropathy, Trental
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 12 Jan 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.
The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.
Detailed description
Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include pain, tingling, cold-sensitivity and numbness that typically presents in a stocking glove distribution. The pathogenesis of PIPN may be attributed to drug accumulation in dorsal root ganglia causing increase in inflammatory cytokines, immune mediators and dysregulation of calcium subunits which in turn increases pain. It also causes oxidative stress in sensory axons leading to axon demyelination, increased sensitization to signal transduction, release of pro-inflammatory mediators and activation of apoptosis.
Many animal studies and clinical trials have shown pentoxifylline to have a significant anti-inflammatory and antioxidant effect. It also preserved nerve conduction velocity and ameliorated mechanical hyperalgesia. Pentoxifylline showed a prominent reduction in neuropathic pain in diabetic patients. These effects were mainly due to the ability of pentoxifylline to reduce TNF-α and MDA levels. So, pentoxifylline is a drug of interest due to its ability to ameliorate neuro-inflammation and oxidative stress which play a critical role in PIPN pathogenesis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, randomized, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| pentoxifylline 400 mg | Experimental | Drug: Pentoxifylline, Drug: PaclitaxelPatients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and pentoxifylline 400 mg twice daily for the paclitaxel treatment period. |
| Placebo | Placebo comparator | Drug: Paclitaxel, Drug: PlaceboPatients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and placebo twice daily for the paclitaxel treatment period.. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients (18-80 years old).
- Female patients.
- Pathologically proved breast cancer.
- Breast cancer patients who will receive adjuvant and neoadjuvant weekly paclitaxel for 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance ≤ 2
Key exclusion criteria (8 listed)
- Patients with preexisting clinical neuropathy.
- Patients with diabetes mellitus.
- Metastatic breast cancer.
- Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics.
- Patients treated with medications that increase the risk of 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 |
|---|---|---|
| PentoxifyllineAlso: TrentalPentoxifylline 400 mg oral tablet twice daily for 12 weeks. | Drug | pentoxifylline 400 mg |
| PaclitaxelAlso: TaxolPaclitaxel I.V 80 mg/m2 weekly | Drug | Placebo, pentoxifylline 400 mg |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Incidence of Paclitaxel induced-peripheral neuropathy
Time frame: 12 weeks
Number of patients reported neuropathy due to paclitaxel
3 secondary outcomes
Grade of severity of Paclitaxel induced-peripheral neuropathy in patients who developed neuropathy
Time frame: at baseline and on weekly bases for 12 weeks
Evaluation of Safety and tolerability of pentoxifylline
Time frame: evaluation on weekly bases for 12 weeks.
The need for dose reduction or drug discontinuation in pentoxifylline and placebo arm.
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 23 Jan 2024.
- 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 2/3 study testing Pentoxifylline and Paclitaxel in people with Breast Cancer Female and Peripheral Neuropathy, run by Ain Shams 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 7 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 23 Jan 2024. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence 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?
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 23 Jan 2024.