| CTRI Number |
CTRI/2021/09/036497 [Registered on: 14/09/2021] Trial Registered Prospectively |
| Last Modified On: |
06/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Oro-T ORAL RINSE (IN-100000264) in Mitigation and Treatment of
Oral Mucositis during Cancer Radiotherapy with or without Chemotherapy in Head and Neck |
|
Scientific Title of Study
|
An Open Label, Randomized, Multicentric, Comparative Clinical Study to Evaluate the
Efficacy and Safety of Oro-T ORAL RINSE (IN-100000264) in Mitigation and Treatment of
Oral Mucositis during Cancer Radiotherapy with or without Chemotherapy in Head and Neck
Cancer Patients |
| Trial Acronym |
Oro-T ORAL RINSE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/031/2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Patil |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Medical Oncology,
11th Floor, Room no.1110, Homi Bhabha Block , Tata Memorial Hospital Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head- Medical services and clinical development |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No 301,3rd Floor Clinical Phramacology. Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
rajesh.kumawat@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Clinical Trial Manager |
| Affiliation |
The Himalaya Drug Company |
| Address |
Room No 301,3rd Floor Clinical Phramacology. Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company. Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162 |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company. Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shirley Lewis Salins |
Manipal Comprehensive cancer care center |
Manipal Centre for Clinical Research
Room no: 32
Mezzanine Floor of OLD KMC Library Building,
Near KMC Dean Office,
MAHE, Manipal – 576 104
Karnataka, INDIA
Udupi
KARNATAKA |
9969557231
shirley.salins@manipal.edu |
| Dr Vijay Patil |
Tata Memorial Hospital |
Department of Medical Oncology,
2nd Floor, Room no. 204, Homi Bhabha Block , Tata Memorial Hospital Parel 400012
Mumbai
MAHARASHTRA |
9869382266
vijaypgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Tata Memorial Centre |
Submittted/Under Review |
| MAHE Ethics Committee |
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:K137||Other and unspecified lesions of oral mucosa. Ayurveda Condition: MUKHARSAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oro-T ORAL RINSE |
Subjects will be advised to use (Rinse/swish the oral cavity) 10 ml of Oro-T ORAL RINSE for 1 minute 4 times daily (without any dilution). |
| Comparator Agent |
Salt with or without ½ tsp of Baking Soda |
Subjects will be advised to use (Rinse/swish the oral cavity) ½ tsp of Salt with or without ½ tsp of Baking Soda in 1 cup (250 ml) of luke warm water for 1 minute 4 times daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or non-pregnant / non-lactating female Subjects between ≥18 to ≤65 years of age.
2.Subjects with histologically or cytologically confirmed Head and Neck cancer.
3. Subjects scheduled to receive radiotherapy as a continuous course of IMRT (Intensity-modulated radiation therapy) with single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 70 Gy
With or without
Chemotherapy: Subjects scheduled to receive a standard weekly regimen of Chemotherapy, which is prone to develop Oral Mucositis (e.g Regimens include Cisplatin / Cetuximab/ Paclitaxel/ Everolimus/ 5-FU).
4. Subjects with adequate visual access for examination of the oral cavity viz: lips, buccal mucosa, floor of mouth, ventral and lateral tongue and soft palate.
5. ECOG performance status ≤2
6. Subjects must have adequate marrow function.
7. Subject must consent to access, review and analysis of previous medical and cancer history, including imaging data by the sponsor or a third party nominated by the sponsor.
8. Ability to understand and sign a written informed consent document prior to any study-related procedures and ready to follow and in agreement to visits as per the study assessment visits.
9. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraceptive measures (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study, and for 15 days following completion of study participation. |
|
| ExclusionCriteria |
| Details |
1.Subjects with Metastatic disease
2. Subjects received chemotherapy or radiation treatment to the head and neck region within the previous 6 weeks
3. Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at study entry
4. Subjects requiring parenteral or gastrointestinal tube-delivered nutrition for any reason.
5. Subjects with presence of symptoms associated with Oral Mucositis like burning sensation, difficulty in chewing, difficulty in drinking and difficulty in mouth opening at the time of enrollment.
6. Known history/ case of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
7. Any significant, uncontrolled medical diseases or conditions, as assessed by the Investigators that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, uncontrolled hypertension, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe/ uncontrolled chronic pulmonary disease, uncontrolled clinically relevant pulmonary edema or active uncontrolled infection).
8. Subjects with inadequate hepatic and renal function. 9. Any other significant medical condition of oral cavity including untreated active oral or dental infection, including severe tooth decay (caries) 10. Evidence of immediate life-threatening disease or a life expectancy of less than 3 months as per Investigator’s discretion 11. Subjects who have participated in any investigational drug clinical study within one month of screening. 12. Refractory/ terminally ill patients.
13. Any systemic disorder (including Sjogren syndrome) which have direct impact on the normal condition of oral cavity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the comparative efficacy of Oro-T ORAL RINSE as compared to the Salt with or without Baking Soda water for Oral Mucositis during Cancer Radiotherapy with or without Chemotherapy in terms of:
1.Percentage of subjects developing Oral Mucositis (WHO grade).
2.Delay in the onset of Oral Mucositis. |
Visit 1- Screening (within 7 days prior to Day 1)
Visit 2- Baseline, Day 1
Visit 3- At the end of 1st week/ Day 7 (±1day)
Visit 4- At the end of 2nd week/ Day 14 (±1day)
Visit 5- At the end of 3rd week/ Day 21 (±1day)
Visit 6- At the end of 4thweek/ Day 28 (±1day)
Visit 7- At the end of 5th week/ Day 35 (±1day)
Visit 8- At the end of 6thweek/ Day 42/completion of Radiotherapy/ Chemotherapy(±1day)
Visit 9- EOS: At 3 weeks post completion of Chemotherapy/ Radiotherapy (±1day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of intolerable mucositis
2.Incidence of delay in initiation of scheduled treatments (Radiotherapy/ Chemotherapy) due to Oral Mucositis.
3 Comparative assessment in Quality of Life PROMs (Patient Reported Outcome Measures) questionnaire.
4.Incidence of hospitalization due to Oral Mucositis.
5.Incidence of AE (Oral local adverse event) |
Visit 1- Screening (within 7 days prior to Day 1)
Visit 2- Baseline, Day 1
Visit 3- At the end of 1st week/ Day 7 (±1day)
Visit 4- At the end of 2nd week/ Day 14 (±1day)
Visit 5- At the end of 3rd week/ Day 21 (±1day)
Visit 6- At the end of 4thweek/ Day 28 (±1day)
Visit 7- At the end of 5th week/ Day 35 (±1day)
Visit 8- At the end of 6thweek/ Day 42/completion of Radiotherapy/ Chemotherapy(±1day)
Visit 9- EOS: At 3 weeks post completion of Chemotherapy/ Radiotherapy (±1day) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
04/10/2021 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oro-T ORAL RINSE is a polyherbal preparation for delaying the onset and treatment of Oral Mucositis in cancer patients undergoing chemotherapy or radiotherapy. Its natural ingredients help in reducing the inflammation, burning sensation, pain, risk of secondary infections, and promote faster healing. |