A Clinical study to check the whether the Light therapy given along with cancer treatment with radiation (x-ray) prevents mouth sores in Indian Patients with Head and Neck Cancer.
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2024/02/063175
- Lead Sponsor
- Trisamya Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Willing and able 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.
2. Male or non-pregnant or non-lactating female Subjects between more than or equal to 18 to less than or equal to 65 years of age.
3. Histologically or cytologically confirmed, non-metastatic Head and Neck cancer, non- para nasal sinus (PNS), non-Nasopharynx who are receiving Radical or Adjuvant RT to the Oral cavity or Oropharynx with or without concurrent chemotherapy.
4. Adequate visual access for examination of the oral cavity viz- lips, buccal mucosa, floor of mouth, ventral and lateral tongue, soft and hard palate, Alveolus, and dorsal tongue.
5. ECOG performance status less than or equal to 2
6. 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.
7. Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day -1 prior to enrollment.
8. Lactating females must agree to discontinue nursing before the study drug is administered.
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.
1. Reports a history of allergic response(s) to the active ingredient Turmeric or to any of the excipients of the product.
2. Reports history of allergic response(s) to phototherapy.
3. Presence of oral mucositis (WHO Score more than or equal to Grade 1) or other oral mucosal ulceration at study entry.
4. Current evidence of any active oral infection except oral candidiasis.
5. Subjects requiring parenteral or gastrointestinal tube-delivered nutrition for any reason.
6. 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 enrolment.
7. Signs and Symptoms of active dental disease including toothache, severely mobile teeth, draining intraoral fistula, intraoral swelling (not associated with the primary tumor), gingival suppuration, gross caries or fractured teeth involving the pulp.
8. Presence of any oral lesions that may confound the ability to assess oral mucositis grade.
9. Known history or case of HIV or active hepatitis B or C (subjects who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
10. 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 infraction within 6 months of study, severe or uncontrolled chronic pulmonary disease, uncontrolled clinically relevant pulmonary edema or active uncontrolled infection).
11. Subjects with inadequate hepatic and renal function.
12. Any other significant medical condition of oral cavity including untreated active oral or dental infection, including severe tooth decay (caries).
13. Evidence of immediate life-threatening disease or a life expectancy of less than 3 months as per Investigator’s discretion.
14. Subjects who have participated in any investigational drug clinical study within one month of screening.
15. Refractory or terminally ill patients.
16. Any systemic disorder (including Sjogren syndrome) which have direct impact on the normal condition of oral cavity.
17. Pregnant and Lactating Female
18. Other conditions, which in the opinion of the investigator, makes the patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method