Chemotherapy-induced Peripheral NeuropathyNCT05829967
CIPN and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Assiut University.
Trial summary
Neuropathies are a major cause of moderate to severe impairments in cancer patients. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Aug 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: 60 cases aged 18 years to 75 years who receiving taxanes and platinum
Who may be able to join
- Age ≥ 18 and <75 .
- Sex : Male or female
- Adjuvant or metastatic
- Receiving neurotoxic agents " platinum and taxanes "
- No documentation of any other causes of neuropathy in their medical records as : congenital and DM
Who cannot join
- Pt not receiving any neurotoxic CTH.
- Detected other causes of neuropathy.
Trial locations and contacts
No sites are listed yet.
Taha Zaki, Prof contact
About this study
Official title: Chemotherapy Induced Peripheral Neuropathy (CIPN ) and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes at Assuit University Hospital
Neuropathies are a major cause of moderate to severe impairments in cancer patients.
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.
Read the detailed description
Neuropathies are a major cause of moderate to severe impairments in cancer patients .
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.
There are six main substance groups that cause damage to neurons developing CIPN: platinum-based antineoplastic agents, vinca alkaloids, epothilones (ixabepilone), taxanes, proteasome inhibitors (bortezomib) and immunomodulatory drugs (thalidomide).
Platinum-based chemotherapeutics (oxaliplatin, cisplatin and carboplatin) have the highest prevalence rates of CIPN, affecting ~ 70% of patients, often complicated by coasting Acute oxaliplatin-induced peripheral neuropathy (OIPN) can result in prolonged infusion times (~ 22%), dose reduction (15-43%) and treatment cessation (6-21.4%) Taxane-induced peripheral neuropathy (TIPN) (paclitaxel, Docitaxel and Cabazitaxel ) is the most common non-haematological adverse event of treatment,however, docetaxel is generally considered to be less neurotoxic than paclitaxel.
CIPN occurs in a dose-dependent manner usually ,duration of exposure, scheduling and combination therapies are also potential risk factors.
diabetes mellitus and increasing age (≥75 years) have been proposed as strong independent risk factors(9). In addition to ,alcohol abuse, renal insufficiency, hypothyroidism, infections like (HIV) and smoking.
The severity of neuropathies can be graded by (Grading scales of CIPN includes; National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Most commonly used , WHO grading system ,self-assessment by patients is preferable due to consistent underrating by healtcare professionals.
symptoms of CIPN in hands and feet, such as tingling, numbness, cramps can cause problems with regular daily activities , standing and walking , Patients became limited in their daily activities and number of them stated that they became more dependent on others.
Treatment strategies depends on discontinuation or lowering the dose . Persistent neuropathic pain can be treated with anti-seizure medications, antidepressants, or analgesics . In severe painful conditions patients may be referred to the Chronic Pain Clinic.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with CIPN who receiving taxanes and platinum
Number of patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens
Measured: Baseline
Rae of recovery in patients with CIPN who receiving taxanes and platinum
Possibility of recovery in patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens and assessment by nerve conduction test.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Khalifa Fathy, Assiut University
- Investigators
- Taha Zaki, Prof, Principal investigator, Assiut UniversityMohamed Alaa El Deen, Assist prof, Principal investigator, Assiut UniversitySamar El Morshidy, Assist prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829967
- Sponsor's protocol ID
- CIPN
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Induced Peripheral Neuropathy (CIPN ) and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes at Assuit University Hospital
- ClinicalTrials.gov ID
- NCT05829967
- Acronym / sponsor ID
- CIPN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 26 Apr 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.
Neuropathies are a major cause of moderate to severe impairments in cancer patients.
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.
Detailed description
Neuropathies are a major cause of moderate to severe impairments in cancer patients .
Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most frequent side effects caused by antineoplastic agents, with a prevalence from 19% to over 85%.
There are six main substance groups that cause damage to neurons developing CIPN: platinum-based antineoplastic agents, vinca alkaloids, epothilones (ixabepilone), taxanes, proteasome inhibitors (bortezomib) and immunomodulatory drugs (thalidomide).
Platinum-based chemotherapeutics (oxaliplatin, cisplatin and carboplatin) have the highest prevalence rates of CIPN, affecting ~ 70% of patients, often complicated by coasting Acute oxaliplatin-induced peripheral neuropathy (OIPN) can result in prolonged infusion times (~ 22%), dose reduction (15-43%) and treatment cessation (6-21.4%) Taxane-induced peripheral neuropathy (TIPN) (paclitaxel, Docitaxel and Cabazitaxel ) is the most common non-haematological adverse event of treatment,however, docetaxel is generally considered to be less neurotoxic than paclitaxel.
CIPN occurs in a dose-dependent manner usually ,duration of exposure, scheduling and combination therapies are also potential risk factors.
diabetes mellitus and increasing age (≥75 years) have been proposed as strong independent risk factors(9). In addition to ,alcohol abuse, renal insufficiency, hypothyroidism, infections like (HIV) and smoking.
The severity of neuropathies can be graded by (Grading scales of CIPN includes; National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Most commonly used , WHO grading system ,self-assessment by patients is preferable due to consistent underrating by healtcare professionals.
symptoms of CIPN in hands and feet, such as tingling, numbness, cramps can cause problems with regular daily activities , standing and walking , Patients became limited in their daily activities and number of them stated that they became more dependent on others.
Treatment strategies depends on discontinuation or lowering the dose . Persistent neuropathic pain can be treated with anti-seizure medications, antidepressants, or analgesics . In severe painful conditions patients may be referred to the Chronic Pain Clinic.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 60 cases aged 18 years to 75 years who receiving taxanes and platinum
Key inclusion criteria (5 listed)
- Age ≥ 18 and <75 .
- Sex : Male or female
- Adjuvant or metastatic
- Receiving neurotoxic agents " platinum and taxanes "
- No documentation of any other causes of neuropathy in their medical records as : congenital and DM
Key exclusion criteria (2 listed)
- Pt not receiving any neurotoxic CTH.
- Detected other causes 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.
Primary outcome
Number of patients with CIPN who receiving taxanes and platinum
Time frame: Baseline
Number of patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens
Rae of recovery in patients with CIPN who receiving taxanes and platinum
Time frame: Baseline
Possibility of recovery in patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens and assessment by nerve conduction test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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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.
Taha Zaki, Prof contact
Taha Zaki, Prof principal investigator
Assiut University
Mohamed Alaa El Deen, Assist prof principal investigator
Assiut University
Samar El Morshidy, Assist prof principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Assiut University.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walaa Khalifa (01091600834, walaakhalifa64@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with CIPN who receiving taxanes and platinum (time frame: Baseline). The study lists 2 primary outcomes in all. 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 26 Apr 2023.