- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05829967
CIPN and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes
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%.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Walaa Khalifa
- Phone Number: 01091600834
- Email: walaakhalifa64@gmail.com
Study Contact Backup
- Name: Taha Zaki, Prof
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pt not receiving any neurotoxic CTH.
- Detected other causes of neuropathy.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Taha Zaki, Prof, Assiut University
- Principal Investigator: Mohamed Alaa El Deen, Assist prof, Assiut University
- Principal Investigator: Samar El Morshidy, Assist prof, Assiut University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIPN
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