Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT05829967
Status:
UNKNOWN
Last Update Posted:
2023-04-26
First Post:
2023-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CIPN and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes
Sponsor:
Assiut University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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%.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: