| CTRI Number |
CTRI/2025/02/079909 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of cancer treatment induced Oral mucositis with add on homoeopathy to standard care versus the standard care in patients with head and neck cancer |
|
Scientific Title of Study
|
Management of Chemotherapy and radiotherapy induced Oral mucositis with add on homoeopathy to standard care versus the standard care in patients with head and neck cancer - A Randomized Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetna Deep Lamba |
| Designation |
Research Officer Homoeopathy Scientist3 |
| Affiliation |
Central Council Research for Homoeopathy |
| Address |
Room 139 Homoeopathic Treatment Centre Safdarjung Hospital New Delhi
South DELHI 110029 India |
| Phone |
9899396304 |
| Fax |
|
| Email |
drchetnalamba@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunita Gupta |
| Designation |
Senior Professor and Head, Oral Medicine and Radiology |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Maulana Azad Institute of Dental Sciences, MAMC
Delhi University , New Delhi
South DELHI 110002 India |
| Phone |
9654700955 |
| Fax |
|
| Email |
drsunitagupta@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sunita Gupta |
| Designation |
Senior Professor and Head, Oral Medicine and Radiology |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Maulana Azad Institute of Dental Sciences, MAMC
Delhi University , New Delhi
South DELHI 110002 India |
| Phone |
9654700955 |
| Fax |
|
| Email |
drsunitagupta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy 61-65 Institutional Area Janakpuri New Delhi - 110058 India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65 Institutional Area Janak Puri New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Sunita Gupta |
Maulana Azad Institute of Dental Sciences |
Room number 2 Ground Floor Department of Oral Medicine and Radiology Maulana Azad Institute of Dental Sciences New Delhi 110002
Central DELHI |
96547 00955
drsunitagupta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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: K123||Oral mucositis (ulcerative), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Add on homoeopathic treatment |
Homoeopathic medicines in centesimal decimal LM potencies shall be given as an add to standard allopathic medicines
Mother tinctures will be used as a local oral wash where indicated.
Selection of the medicine will be done after case taking on the basis of presenting totality of symptoms. The prescription shall be justified from Materia Medica or Repertory. Potency and dosage shall be as indicated.
For centesimal dilutions (6c, 30c, 200c or 1M potency)
The medicine will be repeated depending on the potency and complaints of the patient in
accordance with the principles of Homoeopathy.
Each dose of indicated medicine shall consist of four globules (size no. 30) mixed in 100 ml of water. It can be administered in fractional or divided doses. Identical placebo in water doses shall be given where required.
For LM potency
The treatment of each patient should begin with 0/1 potency to be followed by next higher
potency, serially, as per need of the case.
Duration of intervention is 8 weeks.
|
| Comparator Agent |
Placebo |
Add on identical placebo shall be given to the control arm with standard allopathic medicines |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects 18 years and above with any stage of head and neck cancer undergoing chemotherapy and or radiotherapy
Subjects with Oral mucositis as per RTOG Scoring Criteria after initiation of chemotherapy and/ or radiotherapy |
|
| ExclusionCriteria |
| Details |
Inability to comply with the study protocol
Subject under any other treatment such as Ayurveda or Unani for Oral Mucositis
Subjects not willing to participate after complete information
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the reduction resolution (Grade 0 whenever it is achieved during study period) or increase in grades/scores of Oral Mucositis Assessment Scale Score in add on homoeopathy and standard care |
At baseline twice weekly for the initial 08 weeks and once weekly subsequent 08 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To compare the changes of Patient Reported Oral Mucositis symptom (PROMS) Questionnaire in add on homoeopathy and standard care |
At baseline twice weekly for the initial 08 weeks and once weekly subsequent 08 weeks |
| • To compare the compliance to prescribed Chemotherapy and/or Radiotherapy in add on homoeopathy and standard care group |
Baseline and 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/03/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral mucositis is a common,
debilitating complication of cancer chemotherapy and radiotherapy, occurring in
about 40 percent of patients. Patients treated with radiation therapy for
head and neck cancer typically receive an approximately 200 centigray daily
dose of radiation, five days per week, for 5 to 7 continuous weeks. Almost all
such patients will develop oral mucositis.
The development of Grade III mucositis warrants
stoppage of radiotherapy as further injury to the mucosa causes permanent
injury to the mucosa. Resolutions occurs 3 to 6weeks after completion of
radiotherapy. In cases of severe oral morbidity, the patient may no
longer be able to continue cancer therapy; treatment is then usually
discontinued. These disruptions in dosing due to oral complications can
directly affect patient survivorship.
A wide variety of validated scales have been
used to record the extent and severity of oral mucositis in clinical practice
and research including the Oral Mucositis Assessment Scale (OMAS) and
Patient Reported Oral Mucositis Symptom (PROMS) will be used for the assessment
and follow up of the cases. The Radiation Therapy Oncology Group (RTOG)
has developed the Acute Radiation Morbidity Scoring Criteria for the evaluation
of Radiotherapy treatments. The RTOG grading is reliant on a ability of
clinician to judge the anatomical changes associated with oral mucositis (size
and characteristics of ulceration) and shall be used for
assessing the inclusion of cases in this study.
Research shows many agents have been tested for
prevention and treatment of mucositis: oral glutamine supplementation,
sucralfate, steroids, immunoglobulin, amifostine, antibiotic lozenges,
chlorhexidine rinses, vitamin E, salt and soda mouthwash, but none of them
showed optimal symptom relief and reduction in the intensity or duration of the
lesions. Thus, there is a need for alternative therapeutic
approaches.
Thus, fundamental and clinical research
studies in Homoeopathy suggest that homoeopathy treatment can influence
the prognosis and quality of life in cancer patients and also help in managing
the repercussions of conventional cancer treatment. However, systematic studies
having statistical rigor are lacking. As individualised homoeopathy has not
been evaluated for treatment induced mucositis, this exploratory study is
proposed. |