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Lazanda in Cancer Patients Receiving Palliative Radiation

NCT03071744 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-12-09

Study results available
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Summary

Advanced cancer patients often require palliative (pain relieving) radiotherapy to treat cancer-related symptoms. The delivery of radiation requires patients to lie still on a hard flat surface, which can result in significant acute (intense) pain and/or breakthrough cancer pain (sudden sharp or stabbing pain), especially when painful bone metastases are present. The current care for most cancer patients receiving radiation is to take an oral (by mouth) opioid medication before the radiation treatment. The pain relieving effects of these medications can take about one hour and can last for 3 to 6 hours, which does not follow the time course of when breakthrough cancer pain occurs.

Lazanda is a pain medication delivered via an intranasal route and is already approved by the U.S. Food and Drug Administration (FDA) for the management of breakthrough cancer pain for patients who are already receiving opioids and who can tolerate opioids for the treatment of cancer pain. Lazanda is fast-acting and convenient for patients to take. The purpose of this study is to assess the change in pain intensity during palliative radiotherapy following study treatment with Lazanda. This study will also explore the impact of the study treatment on the efficiency in delivering the radiation therapy

Conditions

Interventions

DRUG

Lazanda

Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.

Sponsors & Collaborators

  • Joseph Ma

    lead OTHER

Principal Investigators

  • Joseph Ma, PharmD · UCSD

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-03-09
Completion
2018-03-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071744 on ClinicalTrials.gov