| CTRI Number |
CTRI/2023/04/051450 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
31/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cryotherapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of oral cryotherapy compared to normal saline mouth wash on reducing alkylating drug induced mucositis among cancer patients |
|
Scientific Title of Study
|
“Efficacy of oral cryotherapy compared to normal saline mouth wash on reducing alkylating drug induced mucositis among cancer patients at selected tertiary care hospital, Bhubaneswarâ€. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pritilagna Dash |
| Designation |
PG in Medical surgical nursing |
| Affiliation |
Kalinga institute of nursing sciences |
| Address |
KALINGA INSTITUTE OF NURSING SCIENCES,KIMS,PBMH,CAMPIUS-5,BHUBANESWAR.
KALINGA INSTITUTE OF NURSING SCIENCES,KIMS,PBMH,CAMPIUS-5,BHUBANESWAR.
Khordha
ORISSA
751024
India |
| Phone |
7609049496 |
| Fax |
|
| Email |
sbpriti1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfAsokan R |
| Designation |
HOD, Medical surgical nursing |
| Affiliation |
Kalinga institute of nursing sciences |
| Address |
Kalinga institute of nursing sciences,KIMS,PBMH,Campus-5, Bhubaneswar.
Kalinga institute of nursing sciences,KIMS,PBMH,Campus-5, Bhubaneswar.
Khordha
ORISSA
751024
India |
| Phone |
7008326128 |
| Fax |
|
| Email |
asokan@kins.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pritilagna Dash |
| Designation |
PG in Medical surgical nursing |
| Affiliation |
Kalinga institute of nursing sciences |
| Address |
Kalinga institute of nursing sciences,KIMS,PBMH,Campus-5, Bhubaneswar
Kalinga institute of nursing sciences,KIMS,PBMH,Campus-5, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7609049496 |
| Fax |
|
| Email |
sbpriti1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pradyumna bal memorial hospital,KIMS,KIIT University |
|
|
Primary Sponsor
|
| Name |
Pritilagna Dash |
| Address |
KINS,KIMS,KIIT UNIVERSITY |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Pritilagna Dash |
Pradyumna Bal Memorial Hospital,Kalinga institute of medical sciences,CAMPUS-5 |
Oncology ward
Khordha
ORISSA |
7609049496
sbpriti1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,kims |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K123||Oral mucositis (ulcerative), (2) ICD-10 Condition: Z538||Procedure and treatment not carried out for other reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cryotherapy will be given by application of ice cubes to the oral mucosa |
ice cubes given for 60mins,in each 5min interval to avoid discomfort of patient during chemotherapy |
| Comparator Agent |
normal saline mouth wash |
normal saline is administered for 30mins at each 5min interval for 2 to 5mins according to the tolerance level of patients. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients receiving cytotoxic chemotherapeutic drugs (alkylating agents).
Willing to participate in the study and are present during data collection.
Those who can read, write and speak oriya or english.
|
|
| ExclusionCriteria |
| Details |
Patients with any kind of dental problems.
Patients with stage - IV oral mucositis.
Patients with oral cancer and oral surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be a significant reduction of mucositis level in cryotherapy in comparison to normal saline mouth wash |
after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There will be a significant reduction in mucositis level after recieving cryotherapy in cmparison to normal saline mouth wash after 4weeks |
after 4weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
10/04/2023 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mucositis induced by alkylating drugs is very painful,impairing oral communication and dietary intake. Development of severe mucositis may lead to reduction of chemotherapy regimen which results in delayed cancer treatment and worse prognosis.Therefore this study is conducted to investigate the efficacy of cryotherapy compared to normal saline mouth wash on severity and incidence of mucositis reduction,in cancer patients treated with alkylating drugs.Moreover these are simple interventions, has low cost, is safe, and has no adverse effects. |