Clinical trial NCT05829967: CIPN and it's Impact on Quality of Life in Patients Receiving Platinum and Taxanes
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 cases aged 18 years to 75 years who receiving taxanes and platinum

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.

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.

Primary outcomes:
measure: Number of patients with CIPN who receiving taxanes and platinum
timeFrame: Baseline
measure: Rae of recovery in patients with CIPN who receiving taxanes and platinum
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Taha Zaki, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mohamed Alaa El Deen, Assist prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Samar El Morshidy, Assist prof
role: PRINCIPAL_INVESTIGATOR
References: