CIPN and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes

NCT ID: NCT05829967

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-08-01

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%.

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Walaa Khalifa Fathy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taha Zaki, Prof

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Mohamed Alaa El Deen, Assist prof

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Samar El Morshidy, Assist prof

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Walaa Khalifa

Role: CONTACT

walaakhalifa64@gmail.com

01091600834

Taha Zaki, Prof

Role: CONTACT

Other Identifiers

CIPN

Identifier Type: -

Identifier Source: org_study_id