Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer

October 10, 2020 updated by: parmanand jain, Tata Memorial Centre

Prevalence of Paclitaxel Induced CIPN-Related Pain and CIPN in Indian Patients With Breast Cancer : A Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Thane, Maharashtra, India, 400614
        • Anuja Bidkar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Paclitaxel induced CIPN-related pain
Time Frame: 2 years post Paclitaxel Chemotherapy

CIPN-related pain is defined as - neuropathic pain as a result of chemotherapy induced nerve damage .

All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN-related pain score will be documented by using the LANSS scale.

LANSS score>12 will be considered as possible CIPN-related pain for statistical analysis
2 years post Paclitaxel Chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Paclitaxel induced CIPN
Time Frame: 2 years post Paclitaxel Chemotherapy

CIPN defined as - neuropathy symptoms (other than pain) as a result of chemotherapy induced nerve damage .

All patients (who fulfill the inclusion criteria) visiting Tata Memorial Hospital during Feb2017 to Jun2017will be examined in the Medical Oncology OPD by one of the investigators and the current CIPN score will be documented by using the NCI-CTCAE v4.0 grading.

Paclitaxel induced CIPN is defined as NCI-CTCAE Grade 2 or above for statistical analysis
2 years post Paclitaxel Chemotherapy
temporal characteristics and risk factors of CIPN-related pain
Time Frame: 2 years post Paclitaxel Chemotherapy
The distribution, appearance and disappearance of syptoms related to CIPN will be based on special questionnaire.
2 years post Paclitaxel Chemotherapy
Use of Agents offered with an intend to prevent CIPN
Time Frame: 2 years post Paclitaxel Chemotherapy
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
2 years post Paclitaxel Chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Centre

Investigators

  • Study Chair: Anuja Bidkar, DNBAnes, Tata Memorial Centre
  • Study Chair: Aparna Chatterjee, MDAnes, Tata Memorial Centre
  • Study Chair: Sudeep Gupta, DMOnco, Tata Memorial Centre
  • Principal Investigator: Parmanand Jain, MDAnes, Tata Memorial Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

May 31, 2018

Study Completion (ACTUAL)

May 31, 2018

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (ESTIMATE)

January 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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