Chemotherapy-induced Peripheral NeuropathyNCT06562998
Pentoxifylline Role Against Chemotherapy-induced Neuropathy
A study testing Pentoxifylline in people with Chemotherapy-induced Peripheral Neuropathy, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Pentoxifylline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Aug 2024
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients> 18 years old.
- Female patients Breast cancer patients who received paclitaxel-based regimen for 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance ≤ 2-Adequate bone marrow function.
- Adequate liver and kidney function.
Who cannot join
- Children less than 18 years old.
- Evidence of physical diseases or major surgery.
- Patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases.
- Patients with preexisting clinical neuropathy.
- Patients with diabetes mellitus.
- Metastatic breast cancer.
Show all 11Show fewer
- 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 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: Pentoxifylline Prophylactic Role Against Paclitaxel Chemotherapy-induced Neuropathy
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.
- Being tested
- Pentoxifylline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Pentoxifylline 400mg twice daily plus paclitaxel based regimens for 12weeks.
| Study group | Role | What they receive |
|---|---|---|
| PTX group | Active comparator | paclitaxel based regimens plus Pentoxifylline 400mg twice daily for 12weeks. Receives: Drug: Pentoxifylline |
| Control group | Placebo comparator | include those assigned for Taxol-based chemotherapy without intervention for 12 weeks Receives: Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale
Measured: 12 weeks
Secondary outcomes (1)
Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)
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 posted20 Aug 2024
- Study start1 Jul 2022
- Primary completion1 Apr 2024
- Study completion1 Aug 2024
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 Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562998
- Sponsor's protocol ID
- FMBSUREC/07072024
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kidwani MA, Osama H, Hassan A, Abdelrahim MEA. Prophylactic role of pentoxifylline against paclitaxel-induced neuropathy among patients with breast cancer: a randomized-controlled trial. Anticancer Drugs. 2025 Feb 1;36(2):126-134. doi: 10.1097/CAD.0000000000001666. Epub 2024 Oct 16.
PubMed 39423312
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline Prophylactic Role Against Paclitaxel Chemotherapy-induced Neuropathy
- ClinicalTrials.gov ID
- NCT06562998
- Acronym / sponsor ID
- FMBSUREC/07072024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 Aug 2024 (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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTX group | Active comparator | Drug: Pentoxifyllinepaclitaxel based regimens plus Pentoxifylline 400mg twice daily for 12weeks. |
| Control group | Placebo comparator | Drug: Pentoxifyllineinclude those assigned for Taxol-based chemotherapy without intervention for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients> 18 years old.
- Female patients Breast cancer patients who received paclitaxel-based regimen for 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance ≤ 2-Adequate bone marrow function.
- Adequate liver and kidney function.
Key exclusion criteria (11 listed)
- Children less than 18 years old.
- Evidence of physical diseases or major surgery.
- Patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases.
- Patients with preexisting clinical neuropathy.
- Patients with diabetes mellitus.
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 |
|---|---|---|
| PentoxifyllinePentoxifylline 400mg twice daily plus paclitaxel based regimens for 12weeks. | Drug | Control group, PTX group |
Primary outcome
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale
Time frame: 12 weeks
1 secondary outcome
Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)
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 20 Aug 2024.
- Derived from this study: PubMed 39423312Kidwani MA, Osama H, Hassan A, Abdelrahim MEA. Prophylactic role of pentoxifylline against paclitaxel-induced neuropathy among patients with breast cancer: a randomized-controlled trial. Anticancer Drugs. 2025 Feb 1;36(2):126-134. doi: 10.1097/CAD.0000000000001666. Epub 2024 Oct 16.
- 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 study testing Pentoxifylline in people with Chemotherapy-induced Peripheral Neuropathy, run by Beni-Suef 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 4 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 20 Aug 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.
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?
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale (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 NCT06562998, 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 20 Aug 2024.