| CTRI Number |
CTRI/2024/11/076391 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Neuropathic pain in post chemotherapy patients with gynaecological cancer: A cross sectional study |
|
Scientific Title of Study
|
Neuropathic pain component in Chemotherapy-induced peripheral neuropathy among patients being
treated for gynaecological cancer: a cross-sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepanshu |
| Designation |
Post Graduate Resident |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care Second Floor near Main ICU UCMS and GTB Hospital Dilshad Garden
East
DELHI
110095
India |
| Phone |
8800483047 |
| Fax |
|
| Email |
deepanshudeepanshu9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashok Kumar |
| Designation |
Professor and Ex-Head of Department |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care Second Floor near Main ICU UCMS and GTB Hospital Dilshad Garden
East
DELHI
110095
India |
| Phone |
9810431367 |
| Fax |
|
| Email |
profashoksaxena2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepanshu |
| Designation |
Post Graduate Resident |
| Affiliation |
UCMS and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care Main ICU second floor University college of medical Sciences and GTB Hospital Dilshad Garden
Delhi
East
DELHI
110095
India |
| Phone |
8800483047 |
| Fax |
|
| Email |
deepanshudeepanshu9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Dilshad Garden
|
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
Shahdara, Delhi-110095, India. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR deepanshu |
Ucms Guru Teg Bahadur Hospital and Delhi State Cancer Institute. |
MCH 7th Floor University College of Medical Sciences and Guru Teg Bahadur Hospital Delhi and OPD Room No 5, Delhi State Cancer Institute.
North East
DELHI |
8800483047
deepanshudeepanshu9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-Human Research, University College of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL; |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patients who are pathologically confirmed as gynaecological cancers receiving multiple cycle of chemotherapy of any type at DSCI, Delhi and patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with history of diabetes mellitus, diabetic peripheral neuropathy
Patients with history of thyroid disorders
Ptients with history of alcohol abuse
patients with history of focal neuropathy such as carpel tunnel syndrome
patients with history of chemotherapy for other malignancy other tha gynaecological cancers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and evaluate the proportion of gynaecological cancer patients
experiencing neuropathic pain component in CIPN by utilizing DN4 Questionnaire Score NPSI Questionnaire Score
NRS numbness Score and NRS weakness Score. |
at 3 months after the last cycle of chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess & evaluate the impact of CIPN on quality of life in gynecological cancer
patients using Short Form Health Survey 12
questionnaire score
To assess & evaluate the co-relation between DN4and SF-12 & relevant
NPSI(Neuropathic Pain Symptom Inventory) & SF-12.
To assess & evaluate the co-relation between NRS-numbness Score & SF-12 & NRS weakness Score & SF-12. |
at 3 months after the last cycle of chemotherapy |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study title: Neuropathic Pain Component in Chemotherapy-Induced Peripheral Neuropathy among patients being treated for gynaecological cancer: a cross sectional study Rationale: Chronic neuropathic pain is defined as “pain that arises as a direct consequence of a lesion or disease affecting the somatosensory system lasting for more than 3 months. It affects 8-10% of world population and 40% of the patients with neurological disorder. There are various aetiologies such as diabetic peripheral neuropathy, post herpetic neuralgia, HIVinduced neuropathy, cancer pain etc. etc. Among the various causes of neuropathic pain, chemotherapy-induced peripheral neuropathy (CIPN) is a distressing adverse effect of various commonly used chemotherapeutic drugs. With an estimated 19.3 million incident cancer cases and 10 million deaths due to cancer in 2020. No doubt chemotherapy is one of the earliest method of tumor management which can minimise the risk of recurrence and enhance the overall survival. CIPN may develop following the use of chemotherapeutic agents like oxaliplatin (Oxaliplatin-induced peripheral neuropathy), paclitaxel and docetaxel etc. Hence the present study has been designed to assess and evaluate Neuropathic Pain Component in CIPN among patients being treated for gynaecological cancer and to assess and evaluate the impact of CIPN on Quality of Life among patients being treated for gynaecological cancers. Aim: To assess and evaluate the Neuropathic Pain Component in chemotherapy induced peripheral neuropathy among patients being treated for gynaecological cancer. OBJECTIVES: Primary objective:To assess and evaluate the proportion of the patients being treated for gynaecological cancerexperiencing Neuropathic Pain Component in CIPN at three months after the last of chemotherapy by utilising DN4 questionnaire Score, NPSI Questionnaire Score Secondary objective: 1. To assess and evaluate the impact of CIPN on Quality of Life at three months after the last cycle of chemotherapy among patients being treated for gynaecological cancer using Short Form Health Survey Questionnaire Score (SF-12). 2. To assess and evaluate the co-relation between DN4 and SF-12 and relevant NPSI and SF12 among the patients being treated for gynaecological cancer. 3.To assess and evaluate the co-relation between NRS-Numbness Score and SF-12 and NRSWeakness Score and SF-12 among the patients being treated for gynaecological cancer. Material and Methods: Prior to this study clearance of Institution Ethical Committee (IEHHuman) will be obtained in addition to the written and informed consent of each patient (ANNEXURE-6) Place of Study: The study will be conducted in the pain relief clinic under the Department of Anaesthesiology at University College of Medical Sciences & GTB Hospital, Delhi, Department of Delhi state cancer institute (DSCI) and Department of obstetrics and gynaecology at University College of Medical Sciences & GTB Hospital, Delhi. Duration: The study will be conducted from March 2024 to August 2025 Study design: A cross-sectional study 4 Sample size: 100 patients of gynaecological cancer Age: 18-80 years female patients Inclusion criteria: Patients who are pathologically confirmed as gynaecological cancers receiving multiple cycle of chemotherapy of any type at DSCI, Delhi and patients willing to participate in the study. Exclusion criteria: 1. Patients with history of diabetes mellitus, diabetic peripheral neuropathy 2. Patients with history of thyroid disorders. 3. Patients with history of alcohol abuse. 4. Patients with history of focal neuropathy such as carpel tunnel syndrome. 5. Patients with history of chemotherapy for other malignancy other than gynaecological cancers Statistical Analysis: The data obtained for present study will be entered in Microsoft excel2007 and analysed using the SPSS-statistical software 20. The data will be summarised for continuous variable in Mean (SD) or Median Inter Quartile Range (IQR i.e. 25-75 percentile) and the qualitative data will be reported with numbers and percentage. The proportion of Neuropathic Pain Component in CIPN among patients being treated for gynaecological cancer at 3 months after the last cycle of chemotherapy will be calculated along with 95% confidence interval (CI). Linear mixed model with suitable co-variance structures will be used for co-relation of the DouleurNeuropathiqueen 4 Questionnaire score (DN4) of CIPN with Short Form Health Survey questionnaire score (SF-12) and Neuropathic pain symptoms inventory questionnaire score (NPSI) over the time period, 3 months after the last cycle of chemotherapy. Univariance Logistic regression will be utilised to find the association between DouleurNeuropathiqueen 4 Questionnaire score (DN4) of CIPN with age and stage of cancer. Level of significance for the present study will be fixed at 5% or P<0.05 |