| CTRI Number |
CTRI/2020/09/027964 [Registered on: 22/09/2020] Trial Registered Prospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cohort Study |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A study to find out the how many times a particular symptom of nerve related/generated pain can occur in cancer patients |
|
Scientific Title of Study
|
Incidence of different characters of neuropathic pain in cancer patients coming to tertiary care centre in North
India over a period of one year – An Observational study. |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sanjay Dhiraaj |
| Address |
Department of Anaesthesiology,
Sanjay Gandhi Postgraduate
Institute Of Medical Sciences,
Raibareli Rd, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904595 |
| Fax |
|
| Email |
sdhiraaj@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
DrShipra Singh |
| Address |
Department of Anaesthesiology,
Sanjay Gandhi Postgraduate
Institute Of Medical Sciences,
Raibareli Rd, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904554 |
| Fax |
|
| Email |
shiprasingh93@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shipra Singh |
| Address |
Department of Anaesthesiology,
Sanjay Gandhi Postgraduate
Institute of Medical Sciences,
Raibareli Road, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904554 |
| Fax |
|
| Email |
shiprasingh93@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Dr Sanjay Dhiraaj
Professor
Department of Anaethesiology
SGPGIMS
Lucknow
Uttar Pradesh 226014 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjay Dhiraaj |
| Address |
Department of Anesthesiology, SGPGIMS, Lucknow, Uttar Pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShipra Singh |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
OPD in Department of Radiotherapy
Pain OPD and Palliative care ward under department of anaesthesia
SGPGIMS
Raebareily Road
Lucknow
|
9468015064
shiprasingh93@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neoplasms |
|
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate and provide informed consent.
Cancer patients with pain which is related to cancer or treatment of cancer.
Cancer patients with sound mental status.
Cancer patients who able to communicate.
Cancer patients between age group of 18years- 80years |
|
| ExclusionCriteria |
| Details |
Patients not classified as having neuropathic cancer pain as per LANSS pain scale.
Patients already taking medications for neuropathic cancer pain
Cancer patients with pain that is unrelated to cancer
Cancer patients who are not in sound mental state |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out incidence of different characters of neuropathic pain
in cancer patients. |
1year |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
To group different characters of neuropathic pain in cancer patients into phenotypic clusters.
To find out correlation of phenotypes with type of cancer. |
1year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
25/09/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
Brief Summary
Modification(s)
|
An observational study will be conducted with the study population being cancer patients between the age of 18 to 80 years who are classified as having neuropathic pain according to LANSS pain scale. History including patient’s name, age, gender, diagnosis, cancer treatment taken, LANSS score,pain onset, duration, site, character and dermatome affected of the patient selected as per the inclusion and exclusion criteria. After collecting data from all the patients who will be included in the study over a period of one year, it will be analyzed and statistical evaluation will be done to find out the incidence of different characters associated with neuropathic pain in cancer patients. Also find out the correlation between the characters and the type of cancer and possible mechanism causing pain. |
