Condition category
Cancer
Date applied
13/08/2014
Date assigned
02/09/2014
Last edited
25/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Xerostomia is a condition where people are not able to produce enough saliva. It results in thicker, more sticky saliva causing a dry mouth along with difficulties in eating, sleeping, speaking and swallowing. As saliva has antimicrobial properties, xerostomia can also lead to poor oral health, with an increase in tooth decay and erosion of tooth enamel. Radiation-induced damage to the saliva glands is one way in which this condition may occur. Radiation-induced xerostomia (RIX) is a common complaint in head and neck cancer (HNC) patients being treated with radiotherapy. Visco-ease is a new product developed for the treatment of RIX. In previous research, Visco-ease has been shown to change the thick, sticky saliva experienced after radiotherapy back to less sticky, thinner saliva. Here, we will be testing a Visco-ease spray that is given under the tongue. HNC patients being treated with radiotherapy will be given the spray and their xerostomia symptoms compared with what they experience when they are given a placebo, or dummy, spray. Each patient that agrees to take part in the research will also be asked to complete a short questionnaire and diary on their xerostomia symptoms and how these symptoms affect their everyday activities. This will help us to see how well the Visco-ease spray works.

Who can participate?
Adult patients over the age of 18 who are being treated at the Beatson West of Scotland Cancer Centre for HNC with radiotherapy.

What does the study involve?
Just before beginning radiotherapy, patients are asked about any previous illnesses and current medications and given a physical examination. They then complete a short questionnaire about whether they feel they have a dry mouth or thick sticky saliva and how these symptoms affect their everyday activities. From their first week of radiotherapy treatment until they finish treatment, they are asked to use the product by applying a spray under their tongue. They are asked to use their spray as often as needed but at least twice a day seven days a week. One group of patients is given a spray containing Visco-ease and one group is given a spray containing a placebo. Neither the patient nor the doctor know which spray is being used at any time. A study nurse helps the patient administer the spray for the first time and they are monitored for one hour afterwards in hospital. During this time patients are asked to complete a short questionnaire about how their dry mouth feels after taking the spray. Each week, patients return to the clinic and are asked again about medication and any new symptoms, and repeat the questionnaire. Each patient also uses a diary to note how often and when they use the spray. They are also asked to complete the questionnaire about their symptoms at home each evening.

What are the possible benefits and risks of participating?
Visco-ease may help relieve symptoms of dry mouth and sticky saliva, which we expect patients to develop during their radiotherapy treatment. The information we get from this study may allow us, in the longer term, to improve the treatment of HNC patients with RIX. No disadvantages or risks to health have been identified. The components of Visco-ease have all been studied extensively and are natural and common in many foods. Visco-ease simply acts on the surface of the mouth.

Where is the study run from?
This study is sponsored by NHS Greater Glasgow & Clyde and is being performed at The Beatson West of Scotland Cancer Centre, Glasgow.

When is study starting and how long is it expected to run for?
January 2016 to December 2016

Who is funding the study?
Lamellar Biomedical, Ltd (UK)

Who is the main contact?
Dr Claire Paterson, Consultant Clinical Oncologist, Beatson West of Scotland Cancer Centre
Telephone: 0141 301 7068
Maureen Thomson, Consultant Radiographer, Beatson West of Scotland Cancer Centre
Telephone: 0141 301 7424

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claire Paterson

ORCID ID

Contact details

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 OYN
United Kingdom

Type

Public

Additional contact

Dr - -

ORCID ID

Contact details

Clinical Study Team
Lamellar Biomedical Ltd.
Caledonian House
Phoenix Crescent
Strathclyde Business Park
Bellshill
ML4 3NJ
United Kingdom
-
info@lamellar.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GN14ON413; Eudamed number: CIV-15-11-013988

Study information

Scientific title

Assessing the safety and effectiveness of Visco-ease for the treatment of Radiotherapy Induced Xerostomia in head and neck cancer patients

Acronym

Study hypothesis

Current hypothesis as of 22/01/2016:
Lamellar Biomedical believe that Visco-ease, which is a phospholipid mimetic of naturally occurring extra-alveolar lamellar bodies, could be used to ameliorate xerostomia (dry mouth) following RT, in the head and neck area, by increasing saliva fluidity.

The purpose of this study is to observe and identify changes in disease specific oral Quality of Life (QoL) questionnaire and symptoms taken from the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire and to collect ongoing safety surveillance data on Visco-ease and placebo when administered as an oral spray in subjects with RT induced Xerostomia.

Previous hypothesis:
Lamellar Biomedical believe that Visco-ease, which is a phospholipid mimetic of naturally occurring extra-alveolar lamellar bodies, could be used to ameliorate xerostomia (dry mouth) following RT, in the head and neck area, by increasing saliva fluidity.

The purpose of this clinical follow-up investigator-led study, is to observe and identify changes in disease specific oral Quality of Life (QoL) questionnaire and symptoms taken from the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire and to collect ongoing safety surveillance data of 3 concentrations of Visco-ease and placebo when administered as an oral spray in subjects with RT induced Xerostomia.

Ethics approval

West of Scotland REC 4, 05/01/2016, Ref: 15/WS/0281

Study design

Randomised parallel-group double-blind single-centre placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Radiotherapy Induced Xerostomia (RIX).

Intervention

Current interventions as of 22/01/2016:
1. Visco-ease (19.6 mg/mL LMS-611),1 spray under the tongue twice daily to PRN
2. Placebo (physiological saline), 1 spray under the tongue twice daily to PRN

Previous interventions:
1. Visco-ease (5), 5 mg/ml LMS-611,1 spray under the tongue twice daily to PRN
2. Visco-ease (10), 10 mg/ml LMS-611,1 spray under the tongue twice daily to PRN
3. Visco-ease (20), 20 mg/ml LMS-611,1 spray under the tongue twice daily to PRN
4. Placebo, physiological saline, 1 spray under the tongue twice daily to PRN

Intervention type

Device

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 22/01/2016:
The primary outcome is change in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome will be compared between Visco-ease and the placebo treatment

Time points for GRIX primary outcome measure:
1. Visit 1 (Baseline): Start of treatment (day 1)
2. Visit 7: End of treatment (day 40 +/- 3 days)

Previous primary outcome measures:
Disease specific oral QoL identified from the Groningen Radiotherapy-Induced Xerostomia (GRIX) questionnaire completed at clinic.

Baseline characteristics will be summarised for all randomised participants. Efficacy endpoints before, after and as the change during each treatment period will be summarised by treatment group.

Time points for GRIX primary outcome measure:
1. Baseline, start of treatment 1 (Day 14)
2. End of treatment 1 (day 18)
3. Start of treatment 2 (day 21)
4. End of treatment 2 (day 25)
5. Start of treatment 3 (day 28)
6. End of treatment 3 (day 32)
7. Start of treatment 4 (day 35)
8. End of treatment 4 (day 39)

Secondary outcome measures

Current secondary outcome measures as of 22/01/2016:
1. Occurrence of any at least possibly device related SAEs throughout the treatment period
2. Number of at least possibly device related SAEs throughout the treatment period
3. Additional safety outcomes including adverse events, withdrawal, vital signs and concomitant medication use
4. Number of treatment administrations as recorded in the patient diary
5. Domiciliary GRIX scores
6. Follow-up GRIX scores taken two weeks after completion of treatment
Secondary outcomes will be compared between Visco-ease and the placebo treatment

Secondary outcome measure time points:
1. SAEs occurring from Visit 1 (start of treatment) until Visit 8 (follow-up contact) will be recorded each week from Visit 2 onwards, and during follow-up where required
2. SAEs will be recorded throughout the treatment period as per (1.)
3. AEs, Vital Signs and Concomitant Medication will be recorded at each visit from start of treatment to final visit (end of study/premature discontinuation visit) and during follow-up where required
4. Daily diary records including number and timing of treatment administrations will be completed at home by the patient each day, from Visit 1 – Visit 7
5. Daily record cards including GRIX questionnaires will be completed at home by the patient each day, from Visit 1 – Visit 7
6. GRIX questionnaire will be completed by the investigator via telephone call with the patient at Visit 8 (14 +/- 5 days after Visit 7)

Previous secondary outcome measures:
Ongoing post market surveillance of Adverse Events (AE)
1. Domiciliary (at home) Symptom scores identified from the GRIX questionnaire
2. Global symptom scores
3. Diary records of use of Visco-ease
4. Adverse Events (AEs)
5. Withdrawal from study
6. Vital signs
7. Use of concomitant medications

Secondary outcome measure time points:
1. Daily record cards including GRIX questionnaires will be completed at home by the patient for the following treatment periods: Treatment period 1 (Day 14-18), Treatment 2 (Day 18-21), Treatment Period 3 (Day 28-32), Treatment Period 4 (Day 35-39)
2. AE’s and Concomitant Medication will be recorded at each visit from screening to day 39; final visit (end of study/premature discontinuation visit) and during follow-up where required
3. Vital signs will be recorded at the beginning of each treatment period, (Days 14, 21, 28 & 35) and at the final visit (end of study/premature discontinuation visit) and during follow-up where required

Overall trial start date

28/01/2016

Overall trial end date

30/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject has provided written informed consent
2. Male or female ≥18 years of age
3. Patients prescribed radiotherapy or chemoradiotherapy as primary treatment for head and neck tumours where one or more parotid glands will receive a significant dose of dose of radiation as judged by the CI or PI during the radiotherapy planning process

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 patients screened to randomise 35 patients

Participant exclusion criteria

Current exclusion criteria as of 22/01/2016:
1. Subject is pregnant or breast feeding
2. Subjects with known allergies to egg, soya, or lanolin (sheep’s wool grease) based products
3. Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjögrens) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure
4. Subjects who have participated in an investigational medicinal product study within 30 days prior to signing consent
5. Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (at the discretion of the CI or PI)
6. Subjects who are unable to complete the questionnaire or diary
7. Subjects who are judged inappropriate for inclusion in the study by the CI or PI
8. Subjects with head and neck cancer who have had surgery to the primary site. Neck dissection alone is not an exclusion

Previous exclusion criteria:
1. Subject is pregnant or breast feeding
2. Subjects with known allergies to egg and soya based products
3. Subjects with a history of an autoimmune disease with pre-treatment xerostomia (e.g. Sjogrens) or other underlying systemic illness known to cause xerostomia independent of prior radiation therapy exposure
4. Subjects who have participated in an investigational study within 30 days prior to signing consent
5. Any clinically significant disease or condition that may interfere with the study treatment or outcome of the study (e.g., metabolic conditions, renal, cardiac or hepatic conditions)
6. Patients who are unable to complete the questionnaire or diary
7. Patients who are judged inappropriate for inclusion in the study by the CI or PI
8. Patients who have had surgery as primary treatment for head and neck cancer (other than neck dissection alone)

Recruitment start date

01/02/2016

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
Glasgow
G12 OYN
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde (UK)

Sponsor details

c/o Paul Dearie
NHS Greater Glasgow & Clyde
Research and Development
NHS Greater Glasgow and Clyde
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Lamellar Biomedical Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The findings of this study will be presented at appropriate Head and Neck Oncology conferences and submitted for publication in peer-reviewed radiation oncology journals. The results will also be published on the funder’s website: www.lamellarbiomedical.com

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 22/01/2016 the following changes were made to the trial record: 1. The scientific title was changed from 'Determining efficacy and optimum preparation Visco-ease for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck cancer patients' to 'Assessing the safety and effectiveness of Visco-ease for the treatment of Radiotherapy Induced Xerostomia in head and neck cancer patients' 2. The study design was changed from 'Randomised double-blind single-centre four-way crossover trial' to 'Randomised parallel-group double-blind single-centre placebo-controlled trial' 3. The overall trial start date was changed from 01/11/2014 to 28/01/2016. 4. The overall trial end date was changed from 31/10/2015 to 30/12/2016. 5. The target number of participants was changed from '36 patients screened to randomise 24 patients' to '50 patients screened to randomise 35 patients'