Health Condition 1: K123- Oral mucositis (ulcerative)
Conditions
Interventions
Intervention1: Thymoquinone gel: Dose Formulation:Gel,Route of Administration:Topical,Dosage Level(s):Thrice a day before meal
Control Intervention1: Placebo: Dose Formulation:Gel,Route of Administrat
Sponsors
Intas Pharmaceuticals Limited India
Eligibility
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1 Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study.2 Male and/or female participant must be more than or equal to 18 years, at the time of signing the informed consent.3 Participants who are medically stable on the basis of physical examination, medical history, vital signs and 12 lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.4 Participants who are medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum biochemistry panel, or hematology, are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant source documents and initialed by the investigator.5 Histologic confirmed documentation of malignant head and neck cancer planning to start a course of RT(either primary or post-operative with chemotherapy) including the oral cavity and/or oropharyngeal area to a dose of less than or equal to 50 to more than or equal to 72 Gy using 1.60 to 2.20 Gy per fraction as per independent clinical judgment of treating physician based on clinical practice guidelines-�At least one third of the oral cavity mucosa (maxillary or mandibular labial mucosa, right or left buccal mucosa, right or left ventral and/or lateral tongue, floor of oral cavity, or palate/tonsillar pillars) must be included in the radiation therapy fields. �Stereotactic body radiation therapy [SBRT] is not allowed.�Post-surgical participants may be enrolled provided any head/neck surgical sites (including sites of dental extractions) are sufficiently healed. Participants who may have surgery in the future are eligible.�Unavoidable doses of at least 50 Gy, to include entrance, exit, and scatter doses, still constitutes planned radiation 6 Have a plan to receive a standard cisplatin chemotherapy regimen administered weekly (30-40 mg/meter per dose for 6-7 doses) or every 21 days (80-100 mg/meter per dose for 3 doses) as per independent clinical judgment of treating physician based on clinical practice guidelines.7 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.8 Ability to complete questionnaire(s) by themselves or with assistance.9 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies �Is not a woman of childbearing potential (WOCBP) OR�Is a WOCBP and using an acceptable contraceptive method during the intervention period and at a minimum 30 days until after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.�A WOCBP must have a negative serum pregnancy test at screening and urine pregnancy test on Day 1 (before randomization) before the first dose of study intervention.�If a urine test cannot be confirme
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study:1 History of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances within last 6 months from screening visit.2 Current evidence of any active oral infection except oral candidiasis.3 Presence of oral mucositis (WHO Score more than or equal to Grade 1) at study entry.4 Requirement for significantly modified diet (liquids and ornothing by mouth) due to compromised oral/pharyngeal function at baseline.5.Will have incompletely healed sites of dental extractions on first day of chemoradiation treatment.6 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.7 Presence of any oral lesions that may confound the ability to assess oral mucositis grade.8 Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline.Note: Participants who have gastrostomy tubes prophylactically placed are eligible. Participants receiving supplemental nutrition through a gastrostomy tube at baseline may be eligible depending on diet. 9 Prior radiotherapy to the region of the study cancer for any reason or condition.10 Had major surgery except surgery for primary cancer under study, (eg requiring general anesthesia)within 4 weeks before initiation of RT, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate.11 History of hepatitis B surface antigen HBsAg or hepatitis C antibody anti-HCV positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.12 History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.13 Lymphoma, leukemia, or any malignancy except disease under study within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years carcinoma in situ of the cervix or malignancy, which is considered cured with minimal risk of recurrence.14 Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer, before the signing the consent. 15 Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of thymoquinone gel 0.1% compared to placebo for reducing OM in participants undergoing chemoradiation for the treatment of head and neck cancer beginning from the start of chemoradiation therapy (CRT) until 4 weeks following its completionTimepoint: Cumulative incidence of severe (grade 3 to 4 by the WHO scale) oral mucositis | — |
Secondary
| Measure | Time frame |
|---|---|
| To further characterise the efficacy of thymoquinone gel 0.1% compared to placebo for reducing OM in participants undergoing chemoradiation for the treatment of head and neck cancer beginning from the start of chemoradiation therapy (CRT) until 4 weeks following its completion.Timepoint: -Duration (in days) of severe OM assessed by WHO scale -Time to Onset (in days) of severe OM assessed by WHO scale -Cumulative incidence of severe oral mucositis assessed by oral mucositis assessment scale(OMAS)-Use of analgesics to control oral pain (number and percentage of participants using per type)-Total dose of opioid analgesics used for mucositis | — |
Countries
India
Contacts
Public ContactPrashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed