None listed
Conditions
Brief summary
TGR Biosciences has obtained the rights to a bioactive extract from milk named whey growth factor extract (WGFEA). Research on this product has included establishing a processing strategy to enrich the biologically active components in milk, characterising these components, and testing the biological activity of the material using in vitro and animal experimental models. A target symptom for treatment by the extract is chemotherapy induced mucositis. The damage to oral and gastrointestinal tissues from chemotherapy and radiation therapies is referred to as "mucositis" which is a painful and debilitating condition for which there is no available preventative treatment. With the advent of bone marrow or peripheral stem cell transplants to improve immune cell number, mucositis is now the limiting toxicity in patients receiving high-dose chemotherapy. The potential benefits of a successful preventative therapy for mucositis include reduced patient suffering, reduced cost of hospitalisation, an increased tolerance to higher dose chemotherapy and therefore more effective tumour treatment. WGFEA has been examined in two previous clinical trials including a Phase IA safety evaluation of the extract in healthy volunteers that demonstrated safety and tolerance in the form of mouthwash and slow dissolving mucoadhesive patch and a Phase IB trial that further demonstrated safety and tolerance of the mouthwash and also showed promising effects in decreasing the duration and severity of mucositis. As the next stage of this work, a Phase II study aims to further examine safety and efficacy. The trial will investigate the ability of the extract to reduce the severity of chemotherapy induced mouth ulcers and will also provide additional safety information about the product.
Interventions
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.
Sponsors
TGR Biosciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
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.
Outcome results
None listed