Conditions: Oral Mucositis
Keywords: radiation therapy chemotherapy head and neck cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
The initial proposed clinical study will be conducted in adult head and neck cancer subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care. Santalis believes that the proposed study is a prudent and appropriate approach to investigate the potential of their product to prevent or improve oral mucositis symptoms commonly seen in subjects undergoing radiotherapy with or without chemotherapy.

Detailed description:
The objectives of this proof of concept trial are: to evaluate the efficacy, safety and tolerability of SAN005 when administered to adults for the prevention and treatment of radiation induced oral mucositis.

Subjects will be instructed on the administration of study medication thrice daily till oral mucositis resolves. Subjects will return to the clinic once a week while receiving radiation and then once every two weeks once their radiation has been completed and then until their mucositis has resolved for the Final Study Visit.

Preliminary Efficacy Evaluation will be the severity of pain rated by the Numeric Pain Rating Scale (NRPS) and mucositis grade by Radiation Therapy Oncology Group (RTOG) criteria at Visit 7 (Day 36). Additional secondary efficacy evaluations will include the severity of pain rated by the NRPS and mucositis grade by RTOG criteria at each study visit, frequency of the percutaneous endoscopic gastrostomy (PEG) tube for feeding during the duration of treatment and weight loss from baseline through Visit 5 and 7. The time of mucositis onset and duration will also be used in assessing efficacy. Additional secondary and exploratory endpoints will be outlined in the statistical analysis plan. The overall efficacy is determined by comparing the data to historical controls. Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug. In addition, tolerability evaluations will be performed at each study visit.

Arms:
arm 1: A mouth rinse containing 0.25% East Indian sandalwood oil (EISO), a candidate botanical drug substance. The rinse will be used three times a day for up to ten weeks. The material will not be ingested but used to "swish, gargle and spit".

Interventions: intervention 1: 0.25% EISO mouth rinse
Intervention descriptions: intervention 1: A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis

Protocol document:
Prot_SAP_000.pdf: 



















































































ICF_001.pdf: