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Trial registered on ANZCTR


Registration number
ACTRN12606000083594
Ethics application status
Approved
Date submitted
27/02/2006
Date registered
1/03/2006
Date last updated
1/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and efficacy trial of whey growth factor extract for oral mucositis
Scientific title
A multicentre, double blind, placebo controlled, safety and efficacy trial of whey growth factor extract (WGFEA) for oral mucositis in lymphoma patients undergoing carmustine, etoposide, cytosine arabinoside and melphalan (BEAM) chemotherapy and autologous stem cell transplantation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral mucositis in lymphoma patients 1047 0
Condition category
Condition code
Cancer 1126 1126 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 923 0
Prevention
Comparator / control treatment
Placebo (sterile saline)
Control group
Placebo

Outcomes
Primary outcome [1] 1511 0
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.
Timepoint [1] 1511 0
After 12 days treatment with WGFEA.
Secondary outcome [1] 2705 0
Safety and tolerability of WGFEA
Timepoint [1] 2705 0
Measured throughout the trial period after 12 days treatement with WGFE or placebo.
Secondary outcome [2] 2706 0
Incidence of WHO grade 2, 3 and 4 oral mucositis
Timepoint [2] 2706 0
Measured throughout the trial period after 12 days treatement with WGFE or placebo.
Secondary outcome [3] 2707 0
Duration of WHO grade 2, 3 and 4 oral mucositis after 12 days treatment with WGFEA
Timepoint [3] 2707 0
Measured throughout the trial period after 12 days treatement with WGFE or placebo.
Secondary outcome [4] 2708 0
Duration and incidence of enteral/parenteral feeding
Timepoint [4] 2708 0
Measured throughout the trial period after 12 days treatement with WGFE or placebo.
Secondary outcome [5] 2709 0
Dose and duration of opiate analgesics
Timepoint [5] 2709 0
Measured throughout the trial period after 12 days treatement with WGFE or placebo.
Secondary outcome [6] 2710 0
Improvement in patient assessed oral mucositis and quality of life scores according to the Oral Mucositis Daily Questionnaire (OMDQ).
Timepoint [6] 2710 0
Measured throughout the trial period after 12 days treatement with WGFE or placebo.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1229 0
Commercial sector/Industry
Name [1] 1229 0
TGR Biosciences
Country [1] 1229 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
TGR Biosciences
Address
Country
Australia
Secondary sponsor category [1] 1086 0
None
Name [1] 1086 0
Nil
Address [1] 1086 0
Country [1] 1086 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35580 0
Address 35580 0
Country 35580 0
Phone 35580 0
Fax 35580 0
Email 35580 0
Contact person for public queries
Name 10112 0
Anthony Dyer
Address 10112 0
TGR Biosciences
31 Dalgleish Street
Thebarton SA 5031
Country 10112 0
Australia
Phone 10112 0
+61 8 83546186
Fax 10112 0
Email 10112 0
[email protected]
Contact person for scientific queries
Name 1040 0
Anthony Dyer
Address 1040 0
TGR Biosciences
31 Dalgleish Street
Thebarton SA 5031
Country 1040 0
Australia
Phone 1040 0
+61 8 83546186
Fax 1040 0
Email 1040 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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