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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05829967
Collaborator
(none)
60
14

Study Details

Study Description

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%.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with CIPN who receiving taxanes and platinum [Baseline]

      Number of patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens

    2. Rae of recovery in patients with CIPN who receiving taxanes and platinum [Baseline]

      Possibility of recovery in patients with CIPN who receiving taxanes and platinum compounds in different chemotherapy regimens and assessment by nerve conduction test.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walaa Khalifa Fathy, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05829967
    Other Study ID Numbers:
    • CIPN
    First Posted:
    Apr 26, 2023
    Last Update Posted:
    Apr 26, 2023
    Last Verified:
    Apr 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 26, 2023