Safety and efficacy trial of whey growth factor extract for oral mucositis
- Conditions
- Oral mucositis in lymphoma patientsCancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
- Registration Number
- ACTRN12606000083594
- Lead Sponsor
- TGR Biosciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
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.
Patients with any of the following conditions will be excluded from participation in this trial:1. Medically documented allergies to dairy products.2. Any visual signs of oral mucosal damage or trauma prior to starting the trial treatments.3. Oesophageal, stomach or primary (un-resected) cancer of the colon or rectum.4. Cancer of the oral cavity or tongue.5. An active condition, not chemotherapy-related, causing mucositis or mucosal ulceration such as oral Herpes or Candida infection.6. Intend to use dental appliances including mouth guards or braces during the treatment period. Subjects with dentures may be enrolled.7. Females who are pregnant or breastfeeding. Females who are menstruating and of child bearing potential must use medically approved contraception (i.e., oral contraceptive agents, diaphragm plus spermicide, condom, intrauterine device) one month before, during and one month after the trial.8. Currently use other investigational agents (drug or device) or have received an investigational agent (drug or device) within 30 days of screening.9. Deemed by the investigator or nominee to be uncooperative or unsuitable for inclusion into this trial.10. ave participated in this trial previously and/or who dropped out or were withdrawn.11. Have uncontrolled diabetes.12. Currently use or have received palifermin (Kepivance, AMGEN) for managing oral mucositis within 90 days of screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method