Can giving medication up the nose and through the lining of the mouth control symptoms as effectively as injections for people approaching the end of life? – Pilot Study

Phase 1

• Conditions: Adult hospice in-patients with terminal cancer who are thought to be in the last 1 - 2 weeks of life; MedDRA version: 20.0 Level: PT Classification code 10059513 Term: Palliative care System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0 Level: LLT Classification code 10048683 Term: Advanced cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005009-30-GB
• Lead Sponsor: Gloucestershire Hospitals NHS Foundation Trust and

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-12
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Pilot open label randomised controlled trial:
Adult hospice in-patients fitting the following criteria will be considered for inclusion. Where they have capacity they will be approached to see if they are willing to participate in the study.
If they lack capacity a carer / member of the family will be approached as a legal representative to see if they would consider giving consent on the patient’s behalf.

1. diagnosis of terminal cancer and thought to have an estimated prognosis of between 1 and 2 weeks
2. patients who, in the last 24 hours, have experienced at least one episode of breakthrough pain.
3. taking 60mg or more of oral morphine (or its equivalent) per 24 hours
4. have carers or family members who would be:
- willing to give the study medication to the patient
- likely to be at the hospice at least 25% of the time so that they are likely to be present to administer medication.

The contraceptive requirements are not applicable as the health status of patients is critical and predicted life span is short.

Qualitative Interview Study:
Family members / carers of a patient in the experimental arm of the open label randomised controlled trial, who has administered trial drug will be considered eligible to participate in the qualitative interviews.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Pilot open label randomised controlled trial:
1. patients/ carers/ family members who will not agree to nasal or buccal drug application
2. patients / carers / family members who in the opinion of the clinical team would be too distressed by the idea of participation
3. patients with disease of the nasal/buccal mucosa preventing effective absorption of medication
4. families who are unable to administer breakthrough medication e.g. problems with dexterity
5. history of substance abuse – patient or carer / family.
6. patients with a previously known sensitivity to benzodiazepines and/or opioids
7. people who might not adequately understand verbal explanations or written information given in English. The feasibility study is only recruiting 20 patients and Gloucestershire has a only a very small percentage of people who are not English speaking. It has been decided that it is not cost effective to fund translation for this feasibility study although this information will have to be taken into account when planning a larger study. We will capture information on the numbers of patients that may have been excluded and the languages that might have been needed.
8. Participated in a palliative care trial within the last month.

Qualitative Interview Study:
Unable to understand sufficient English to take part in a semi-structured interview

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified