| CTRI Number |
CTRI/2016/08/007179 [Registered on: 12/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
12/08/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [INTERVENTIONAL PAIN MANAGEMENT] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study efficacy and safety of pulsed radiofrequency as treatment of oral cancer pain. |
|
Scientific Title of Study
|
Efficacy of pulsed radiofrequency ablation for the treatment of oarl cancer pain involving glossopharyngeal nerve. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suryabrata Chattopadhyay |
| Designation |
Junior resident Anaesthesia |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Office of Department of Anaesthesia & Critical Care
Nehru Hospital. Fourth Floor.
PGIMER.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8727083344 |
| Fax |
|
| Email |
drsurya24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Bharti |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Office of Department of Anaesthesia & Critical Care
Nehru Hospital, Fourth Floor
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09915575145 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suryabrata Chattopadhyay |
| Designation |
Junior Resident Anaesthesia |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Office of Department Anaesthesia & Critical Care
Nehru Hospital, Fourth Floor
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8727083344 |
| Fax |
|
| Email |
drsurya24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh- 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education Research |
| Address |
Office of Department of Anaesthesia & Critical Care. Nehru Hospital 4th floor PGIMER Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Suryabrata Chattopadhyay |
Post Graduate Institute of Medical Education & Research |
Office of Department of Anaesthesia & Critical Care
4TH Floor Nehru Hospital
PGIMER-160012
Chandigarh
CHANDIGARH |
08727083344
drsurya24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE(Intramural) PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cancer pain involving glossopharyngeal nerve in a case of oropharyngeal carcinoma with no curative intervention planned, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
Pain scores will be compared pre & post intervention (after 2 weeks) in the same patients |
| Intervention |
Pulsed Radiofrequency Ablation |
Pulsed Radiofrequency Ablation of the Glossopharyngeal nerve causing pain will be performed once under sedation in operation theater |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult population (18-65 years)suffering from oropharyngeal carcinoma with no curative intervention planned( not fit for surgery) undergoing treatment by WHO step ladder II method still complaining of severe pain ( NRS>5) in the base of tongue, tonsillar fossa, pharynx- area mainly supplied by glossopharyngeal nerve. |
|
| ExclusionCriteria |
| Details |
unstable cardio-respiratory disorder
coagulation & hematological disorder
psychological disorder & history drug abuse
non compliant for 3 months follow up
injection site not suitable due to presence of infection , lymph node enlaegement
bilateral involvement of glossopharyngeal nerve |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of PRF ablation of glossopharyngeal nerve for the treatment of cancer pain by pain score by numerical rating scale
|
Post intervention - 1week, 2 week, 1 month, 2 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety profile of PRF of glossopharyngeal nerve in cancer pain |
during & post intervention (120 mins ) & post intervention 1 week, 2 week, 1 month, 2 month,3 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Pulsed Radiofrequency (PRF) treatment has been used previously for the treatment of various pain conditions and found to be safe & effective.In this trial we will study whether PRF treatment of glossopharyngeal nerve is effective & safe in the pain management of oropharyngeal cancer patient suffering from intractable pain which can not be controlled by traditional analgesic therapy at base of tongue, tonsillar fossa, oropharynx( area supplied by glossopharyngeal nerve). PRF of glossopharyngeal nerve will be done at Operation theatre under full aseptic precaution with standard monitoring for vital signs & as day care basis. Post procedure patient will be monitored at PACU for 2 hrs and subsequently patient will be assessed at 1 week, 2week. 1 month, 2 month, 3 month post PRF at pain clinic. During their visit pain score will be noted according to numerical rating scale ( NRS). Treatment will be considered effective if there is 50% reduction in NRS at 2 week post PRF from the base line.
|