A study of patients with dry mouth and sticky saliva during radiotherapy

Not Applicable

Completed

• Conditions: Cancer; Radiotherapy Induced Xerostomia (RIX).

• Registration Number: ISRCTN44528835
• Lead Sponsor: HS Greater Glasgow & Clyde (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31672256 (added 11/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-02
• Study Completion: 2016-12-30
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified