| CTRI Number |
CTRI/2021/05/033603 [Registered on: 13/05/2021] Trial Registered Prospectively |
| Last Modified On: |
11/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of coconut oil application among patient with radiation induced xerostomia] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Topical coconut oil application to improve xerostomia related quality of life. |
|
Scientific Title of Study
|
"Effect of topical coconut oil application versus standard supportive care on xerostomia related quality of life among patient with radiation induced xerostomia in H&N cancer patient in a tertiary care cancer Centre. A randomised control trial." |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meera Sharad Achrekar |
| Designation |
Professor & Deputy Nursing Superintendent |
| Affiliation |
Tata Memorial Hospital |
| Address |
Advance Centre for Treatment, Research & Education in Cancer, Tata Memorial Centre
sector 22 Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769993848 |
| Fax |
|
| Email |
meeraachrekar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Sharad Achrekar |
| Designation |
Professor & Deputy Nursing Superintendent |
| Affiliation |
Tata Memorial Hospital |
| Address |
Advance Centre for Treatment, Research & Education in Cancer, Tata Memorial Centre
sector 22 Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769993848 |
| Fax |
|
| Email |
meeraachrekar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hinal Bhimrao Waghmare |
| Designation |
2nd year Msc Nursing |
| Affiliation |
Homi Bhabha National University |
| Address |
Tata Memorial Hospital college of nursing.
13th floor HBB block Nursing Education department.
Dr. E borges marg parel, Mumbai 12
Tata memorial Hospital college of nursing 13th floor HBB block Nursing Education department.
Dr. E Borges Marg parel,Mumbai 12
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9130223711 |
| Fax |
|
| Email |
hinalwaghmare2994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr. Borges road Parel, Mumbai-400012 |
|
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Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr E borges Road, Parel, Mumbai-400012 Maharashtra India. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meera Sharad Achrekar |
Tata Memorial Hospital |
Head & Neck radiation OPD Room no. 206
Homi Bhabha block 2nd floor Head & Neck OPD Annex building
Tata Memorial Hospital, Dr. E. Borges road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9769993848
meeraachrekar@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coconut oil application |
Participant will be selected according to the inclusion & exclusion criteria. They will be randomly divided into Arm A (Experimental arm). Arm B (control arm) by computer generated randomization table. Participants in arm A (study arm) will receive topical coconut oil (Patanjali roasted coconut oil)application & standard supportive care after completion of radiation therapy this should be followed for 6 month. The coconut oil has to used 4 time in a day that is 3 ml of oil has to apply to entire oral cavity with standard supportive care which include ( 2 time brushing in morning and before going to sleep at night, salt soda water gargle that is 100ml water and 1 pinch of sodium bicarbonate powder.) this also followed for 4 times in a day. Participant will assess by the RTOG grading scale and UOW-QOL questionnaire to grade the xerostomia related quality of life. The follow- up will be taken every 3 month and weekly video calling assessment will be done. |
| Comparator Agent |
Standard supportive care |
Participant will be selected according to the inclusion & exclusion criteria. They will be randomly divided into Arm A (Experimental arm). Arm B (control arm) by computer generated randomization table. Participants in arm B (control arm participant Standard supportive care which include ( 2 time brushing in morning and before going to sleep at night, salt soda water gargle that is 100ml water and 1 pinch of sodium bicarbonate powder.) this also followed for 4 times in a day. Participant will assess by the RTOG grading scale and UOW-QOL questionnaire to grade the xerostomia related quality of life. The follow- up will be taken every 3 month and weekly video calling assessment will be done. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Age > 18 year & < 65 years of head & neck cancer.
2 After completion of radiation therapy treatment. (Radical radiotherapy).
3 Present at the time of data collection.
4 Willing to participate.
- Patient who can follow the instruction. |
|
| ExclusionCriteria |
| Details |
1 Patients having allergy to coconut oil.
2 Patient receiving palliative radiation therapy.
3 Patient with distant metastasis.
4 Not willing to participate. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the xerostomia related quality of life among patient with coconut oil application with standard supportive care versus standard supportive care. |
Participant will be followed by in every 3 month and weekly video calling assessment by RTOG grading scale and UOW-QOL to assess xerostomia related QOL. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the xerostomia related quality of life among patients with xerostomia before & after topical application of coconut with SSC.
2. To assess the xerostomia related quality of life among patient with xerostomia before & after SSC. |
Participants will be followed up for every 3 month that is for 6 month and weekly video calling assessment by using RTOG grading scale and university of Washington QOL to assess the xerostomia related QOL. |
|
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Target Sample Size
|
Total Sample Size="234"
Sample Size from India="234"
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)
|
31/05/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Head & Neck cancers contribute to around 25% of total patients suffering from cancer in India. The burden of head & neck cancers to a large extent can be attribute to abuse of different forms of tobacco used by both Indian males & females. Xerostomia thus is a common feature encountered during & after radiotherapy. The salivary secretion progressively decreases with increase in radiation dose beyond 50Gy. For cure in head & neck cancer doses more than 60Gy are needed though the tolerance of normal organs e.g. salivary glands varies between 32Gy to 40Gy. Out of all the radiation reactions xerostomia is one of the commonest & most troublesome.Coconut oil, it is derived from the derived from the dried kernel of fatty ripe coconut. The mechanism of xerostomia relief from coconut oil may be related to its ability to "coat " the mouth, forming a barrier to keep mucosal surface moist. So with this study i would assess the effect of topical of coconut oil application on xerostomia related quality of life among patient with radiation induced xerostomia in H&N cancer.
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