A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-24

Study Completion Date

2017-02-02

Brief Summary

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The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck cancer patients.

A parallel group double blind study design has been selected. 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.

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Detailed Description

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Conditions

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Xerostomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Visco-ease

Visco-ease is a suspension of multilamellar vesicles comprising lipids in ratios which mimic the lipidic composition of endogenous extra-alveolar lamellar bodies. Visco-ease is suspended in physiological saline (0.9% NaCl) to provide a final dose concentration of 19.6 mg/mL. Visco-ease is a white to off-white turbid suspension. The device under evaluation in this clinical investigation is Visco-ease at a concentration of 19.6 mg/mL.

Group Type EXPERIMENTAL

Visco-ease

Intervention Type DEVICE

19.6 mg/mL of LMS-611

RIX-Placebo

Physiological Saline (sodium chloride 0.9% (w/v)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Physiological Saline

Interventions

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Visco-ease

19.6 mg/mL of LMS-611

Intervention Type DEVICE

Placebo

Physiological Saline

Intervention Type DEVICE

Other Intervention Names

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RIX - LMS-611x-20 OXB/1-20 LMS-611 0.9% (w/v) Physiological Saline

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Subject is pregnant or breastfeeding
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. Sjögren's syndrome) 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 independently 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No