| CTRI Number |
CTRI/2021/05/033616 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
14/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"A study to assess the effectiveness of chewing gum on reducing oral mucositis and quality of life in patient receiving chemotherapy." |
|
Scientific Title of Study
|
“​ A Randomized controlled Trial to assess the
effectiveness of chewing gum on reducing incidence
and severity of chemotherapy induced oral mucositis
and quality of life among patient receiving
conventional mucotoxic chemotherapy.​ †|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Verma |
| Designation |
M.Sc Nursing Oncology Student |
| Affiliation |
College of Nursing,All India Institute of Medical Sciences, New Delhi |
| Address |
College of Nursing
AIIMS
South West
DELHI
110049
India |
| Phone |
09711555063 |
| Fax |
|
| Email |
Neha003aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Pramanik |
| Designation |
Assitant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No:143
Department of Medical Oncology
IRCH AIIMS
South West
DELHI
110023
India |
| Phone |
9711555063 |
| Fax |
|
| Email |
drrajapramanik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Aditi P Sinha |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
College of Nursing
AIIMS New Delhi
South West
DELHI
110023
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
.. |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Neha Verma |
IRCH, AIIMS (NEW DELHI) |
Day care, 1st floor, 2nd floor,5th floor and 7th floor
South
DELHI |
9711555063
Neha003aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no chewing gum |
no chewing gum will be given. Will receive only conventional treatment. |
| Intervention |
sugar free chewing gum |
sugar free chewing gum 1 x QID
for 21 days will be given to the intervention group long with conventional therapy. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patient of age 18yrs or more
2 Patients receiving conventional mucotoxic chemotherapeutic agents(such as Taxane group-Paclitaxel/Docetaxel Antimetabolites-5FU Methotrexate Cytarabine Anthracycline-Doxorubicin Alkylating agents-Cyclophosphamide
3 All new patients going for 1st cycle of conventional mucotoxic chemotherapy
4 Patient with controlled comorbidities
5 Patients with who are able to chew
6 Patients who are able to understand Hindi/English |
|
| ExclusionCriteria |
| Details |
1.Baseline NG tube.
2.Evidence of baseline infection.
3.Patients who are unable to chew.
4.Patients who are unable to understand Hindi/English. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in incidence and severity of oral Mucositis after administration of chewing Gum. |
At baseline and 7th day
At baseline and 14th day
At baseline and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life of patients. |
Day 0,7th, 14th and 21st. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
will publish after thesis submission. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized controlled trial will be conducted in which subjects with conventional mucotoxic chemotherapy attending IRCH Day Care and ward at AIIMS, New Delhi and recieved at least one cycle of chemotherapy. eligible subjects will be identified on the basis of inclusion and exclusion criteria. informed consent will be obtained from subjects. Subjects will be randomized into experimental and control group using the computer generated table of random numbers, Baseline assessment of the subjects will be done for oral mucositis with the help of WHO grading system for oral mucositis and quality of life will be asssessed using OHIP-14 at 7th, 14th and 21st day. Everyday assessment will be done by patients using PROMS Questionairre (Patient Reported Oral Mucositis Scale) using a diary, Afterwards, weekly follow up till three weeks of therapy will be done. For this study data will be collected from1st june 2021- 31Dec 2021. Data analysis will be done by Descriptive/ Inferential Statistics. The report will be submitted after data analysis. In my inclusion criteria age is from 18yrs-65yrs but the value 18yrs could not get entered in the software(it is showing error again and again) and because of this error i have written age from 19yrs-65yrs. |