“​ A Randomized controlled Trial to assess theeffectiveness of chewing gum on reducing incidenceand severity of chemotherapy induced oral mucositisand quality of life among patient receivingconventional mucotoxic chemotherapy.​ â€
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Reduction in incidence and severity of oral Mucositis after administration of chewing Gum.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 19.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Reduction in incidence and severity of oral Mucositis after administration of chewing Gum.
Time Frame: At baseline and 7th day | At baseline and 14th day | At baseline and 21st day
Secondary Outcomes
- Improvement in quality of life of patients.(Day 0,7th, 14th and 21st.)