ANZCTR - Registration

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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

Condition category

Condition code

Cancer

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]

Prevention

Comparator / control treatment

Placebo (sterile saline)

Control group

Placebo

Outcomes

Primary outcome [1]

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]

After 12 days treatment with WGFEA.

Secondary outcome [1]

Safety and tolerability of WGFEA

Timepoint [1]

Measured throughout the trial period after 12 days treatement with WGFE or placebo.

Secondary outcome [2]

Incidence of WHO grade 2, 3 and 4 oral mucositis

Timepoint [2]

Measured throughout the trial period after 12 days treatement with WGFE or placebo.

Secondary outcome [3]

Duration of WHO grade 2, 3 and 4 oral mucositis after 12 days treatment with WGFEA

Timepoint [3]

Measured throughout the trial period after 12 days treatement with WGFE or placebo.

Secondary outcome [4]

Duration and incidence of enteral/parenteral feeding

Timepoint [4]

Measured throughout the trial period after 12 days treatement with WGFE or placebo.

Secondary outcome [5]

Dose and duration of opiate analgesics

Timepoint [5]

Measured throughout the trial period after 12 days treatement with WGFE or placebo.

Secondary outcome [6]

Improvement in patient assessed oral mucositis and quality of life scores according to the Oral Mucositis Daily Questionnaire (OMDQ).

Timepoint [6]

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]

Commercial sector/Industry

Name [1]

TGR Biosciences

Address [1]

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

TGR Biosciences

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Anthony Dyer

Address

TGR Biosciences
31 Dalgleish Street
Thebarton SA 5031

Country

Australia

Phone

+61 8 83546186

Fax

Email

anthony.dyer@tgr-biosciences.com.au

Contact person for scientific queries

Name

Anthony Dyer

Address

TGR Biosciences
31 Dalgleish Street
Thebarton SA 5031

Country

Australia

Phone

+61 8 83546186

Fax

Email

anthony.dyer@tgr-biosciences.com.au

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

No additional documents have been identified.