Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer
Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer
Since its introduction in the 1970s, Paclitaxel has been used as an effective anticancer
 agent against lung, breast, ovarian, leukopenia and liver cancer. But, Paclitaxel-induced
 peripheral neuropathy is the major dose-limiting side effect of paclitaxel.Paclitaxel induced
 peripheral neuropathy most commonly presents as

 1. Pain

 2. Burning,

 3. Tingling ("pins and needles" feeling) or electric/shock-like pain,

 4. Hyperalgesia,

 5. Allodynia,

 6. Increased sensitivity to cold or heat These symptoms are classically seen symmetrically
 in the distal extremities (glove and stocking distribution).

 Most adverse effects associated with chemotherapy are ameliorated after cessation of the
 therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related
 symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of
 neuropathic pain in breast cancer patients has high clinical and public health significance.
PRIMARY AIM / OBJECTIVE:

 Our study aims to observe the prevalence of CIPN-related pain in cancer breast patients who
 have received Paclitaxel based adjuvant chemotherapy where we define CIPN-related pain as -
 "possible" neuropathic pain in patients scoring more than 12 on Leeds Assessment of
 Neuropathic Symptoms and Signs pain scale (LANSS).

 SECONDARY AIM / OBJECTIVE Since its introduction in the 1970s, Paclitaxel has been used as an
 effective anticancer agent against lung, breast, ovarian, leukopenia and liver cancer. But,
 Paclitaxel-induced peripheral neuropathy is the major dose-limiting side effect of
 paclitaxel.Paclitaxel induced peripheral neuropathy most commonly presents as

 1. Pain

 2. Burning,

 3. Tingling ("pins and needles" feeling) or electric/shock-like pain,

 4. Hyperalgesia,

 5. Allodynia,

 6. Increased sensitivity to cold or heat These symptoms are classically seen symmetrically
 in the distal extremities (glove and stocking distribution).

 Most adverse effects associated with chemotherapy are ameliorated after cessation of the
 therapy, but CIPN may persist in the longterm, with 30 % patients having CIPN related
 symptoms beyond 6 months after completion of chemotherapy7.Understanding the epidemiology of
 neuropathic pain in breast cancer patients has high clinical and public health significance.

 MATERIALS & METHODS:

 The cohort will consist of women with early breast cancer (stages I through III) who had
 received Paclitaxel chemotherapy for breast cancer as per the Institutional guidelines within
 the preceding two years. History suggestive of pre-existing neuropathy will be noted.

 1. All patients (who fulfill the inclusion criteria) visiting Tata Memorial hospital during
 Feb2017 2016 to June 2017 will be examined in the Medical Oncology OPD by one of the
 investigators and the current CIPN and CIPN-related pain score will be documented by
 using the NCI-CTCAE and LANSS scale. Then, the patients will be questioned for
 thepresence of similar neuropathic symptoms before starting, after starting and during
 Paclitaxel the chemotherapy and their replies will be recorded in the.

 2. Patients who had received adjuvant chemotherapy with Paclitaxel but who could not
 complete their chemotherapy due to Paclitaxel induced adverse effects other than
 peripheral neuropathy for eg hypersensitivity to Paclitaxel will be screened but their
 data will be excluded from final data assessment.

 2. Use of 1. Acetyl-L-carnitine (ALC) 2. Amifostine 3. Amitriptyline 4. CaMg 5.
 Diethyldithio-carbamate (DDTC) 6. Glutathione (GSH) 7. Nimodipine 8. All-trans-retinoic acid
 9. rhuLIF 10. Vitamin E during Paclitaxel chemotherapy will be noted based on history and
 examination of charts.

 For CIPN-related pain: The Leeds Assessment of Neuropathic Symptoms and Signs pain scale
 (LANSS) is a simple and valid 7-item tool for identifying patients whose pain is dominated by
 neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of
 symptoms (5 items) or clinical signs (2 items). If score > 12, neuropathic mechanisms are
 likely to be contributing to the patient's pain.

 NCI-CTCAE : The National Cancer Institute - Common Terminology Criteria for Adverse Events
 v4.0, NCI-CTCAE most recently updated in 2010, will be used for grading CIPN. The CTCAE
 displays Grades 1 through 5 with unique clinical descriptions of severity for CIPN.
 Paclitaxel induced CIPN is defined as NCI-CTCAE Grade 2 or above.
Inclusion Criteria:

 1. Histopathologically confirmed Primary breast cancer

 2. Patients who had received adjuvant chemotherapy with Paclitaxel and who have completed
 their Paclitaxel chemotherapy within the preceding 2 years i.e. between 1stAugust 2014
 to 31st July 2016.

 Exclusion Criteria:

 1. Age below 18 years

 2. On current Paclitaxel chemotherapy

 3. Patients with radiological evidence of bone metastases.