A double blind pilot study testing the effectiveness of Biotene mouthwash versus Normal Saline mouthwash to reduce the symptoms associated with mucositis in high dose chemotherapy patients.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000057684

Enrollment

Registered

2005-08-01

Start date

2006-02-18

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

One of the most painful and debilitating side effects of chemotherapy is mucoisits. Oral mucositis involves swelling, irritation, and ulceration of the lining of the mouth. Good mouth care including mouthwashes has been shown to relieve symptoms. Currently, there is no strong evidence to support the use of any mouthwash. This is a pilot study to test the mouthwash, Biotene. Patients (24) will receive either Normal Saline or Biotene mouthwashes. The following data will be collected from each group: 1) severity of mucositis, symptoms experienced and 3) compliance with mouth care. Patients will be randomly assigned and unaware of which mouthwash they are to receive.

Interventions

Biotene mouthwash 20mls four times a day for the period of 21 days

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Diagnosed with acute leukaemia, high grade lymphoma, or any other disease that requires high dose chemotherapy and patients receiving an autogenic stem cell transplant 2. In patient of the study hospital and over the age of 18 years 3. Able to read and understand English 4. Agrees to use no other mouthwashes at time of inclusion into study 5. Agrees to participate in an RCT.

Exclusion criteria

1. Patients receiving radiation treatment to head or neck 2. Patients who have a psychiatric history or mental/physical impairment that would hinder the individual to comply with the intervention.

Outcome results