Radioprotective effects of parthenolide lotion against skin injury caused by radiation in people with head and neck cancer

Both the intervention and control lotion are formulated with a base solution comprised of Coconut Water (from freeze-dried coconut powder); Hickory Bark Extract; Lactic Acid, Glycerin, Saccharide Isomerate, Jojoba & Esters. Intervention: Base lotion with 1% parthenolide. Rationale for parthenolide concentration: In vitro dosing of radiation in petri dishes has shown radiation protection of normal cells is achieved with 3 to 10 µM which equates to approximately 1% solution. In vivo experiments noted serum levels of 3 to 10 µM exposure was associated with benefit. Therefore the concentration of parthenolide will be 1%. Amount to be applied: 8 pumps before and after radiation, applied in the radiation unit under supervision by a nurse. Frequency of application: Twice daily (before and after radiation dose) for 6-7 weeks (depending on cycle length, all participants to receive >50Gy radiation to both sides of the neck/face) NO changes to radiation dosing will be implemented by the study team. Changes are only permitted by the treating oncologist. Adherence: Adherence is measured daily, with an adherence log completed by the nurse on duty to confirm application. If application is missed, a reason explaining why is documented. Quality assurance: The lotion will be tested monthly to ensure parthenolide is stable in the lotion. Randomisation of the lotion: The study is non-randomised, with all participants receiving BOTH the intervention and control lotion. The study is double blind, with the intervention and. control lotions labelled LEFT and RIGHT. Nobody in the study (with the exception of the unblinded monitor) knows which lotion is which. The LEFT is always applied to the LEFT side and the RIGHT lotion is always applied to the RIGHT side.