Clinical trial NCT03022162: Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer
Official title: Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer : A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Neuropathic Pain
Keywords: Neuropathic Pain, Paclitaxel, CIPN
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort will consist of all female patients with primary breast cancer who received adjuvant Paclitaxel chemotherapy within the preceding 2 year period, visiting TMH from December 2017 to May 2018.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Paclitaxel induced CIPN-related pain
timeFrame: 2 years post Paclitaxel Chemotherapy
Secondary outcomes:
measure: Prevalence of Paclitaxel induced CIPN
timeFrame: 2 years post Paclitaxel Chemotherapy
measure: temporal characteristics and risk factors of CIPN-related pain
timeFrame: 2 years post Paclitaxel Chemotherapy
measure: Use of Agents offered with an intend to prevent CIPN
timeFrame: 2 years post Paclitaxel Chemotherapy
Other outcomes:
Locations:
city: Thane
country: India
facility: Anuja Bidkar
state: Maharashtra
Study officials:
affiliation: Tata Memorial Centre
name: Anuja Bidkar, DNBAnes
role: STUDY_CHAIR
affiliation: Tata Memorial Centre
name: Aparna Chatterjee, MDAnes
role: STUDY_CHAIR
affiliation: Tata Memorial Centre
name: Sudeep Gupta, DMOnco
role: STUDY_CHAIR
affiliation: Tata Memorial Centre
name: Parmanand Jain, MDAnes
role: PRINCIPAL_INVESTIGATOR
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