Safety and efficacy trial of whey growth factor extract for oral mucositis

INTERVENTION: To assess the safety and efficacy of WGFE at 13.5 mg/ml in sterile saline when compared to placebo (sterile saline). WGFE will be administered as a mouthwash 4 times per day for 12 days in lymphoma patients undergoing BEAM chemotherapy and stem cell transplantation. CONDITION: Oral mucositis in lymphoma patients PRIMARY OUTCOME: Reduction of at least 3 days in the duration of severe (>Grade 3) oral mucositis after treatment with WGFEA when compared with placebo. Oral mucositis will be measured using the WHO grading scale for oral mucositis. SECONDARY OUTCOME: Dose and duration of opiate analgesics Duration and incidence of enteral/parenteral feeding Duration of WHO grade 2, 3 and 4 oral mucositis after 12 days treatment with WGFEA Improvement in patient assessed oral mucositis and quality of life scores according to the Oral Mucositis Daily Questionnaire (OMDQ). Incidence of WHO grade 2, 3 and 4 oral mucositis Safety and tolerability of WGFEA INCLUSION CRITERIA: 1. Have a diagnosis of lymphoma and due to undergo high‐dose BEAM chemotherapy and autologous stem cell transplantation which will be managed primarily as an inpatient. 2. Have a life expectancy of at least 2 months, in the opinion of the investigator. 3. Clinical laboratory values deemed by the investigator to be acceptable to undergo stem cell transplantation. 4. Eastern Cooperative Oncology Group (ECOG) performance status less than 3 (Section 5.2.3).17. 5. Able to provide written informed consent to participate in this trial. 6. Able to understand and comply with the requirements of the trial; be able to abide with the restrictions and return for their required treatments and evaluations without undue hardship.