Rectal Administration of Opioids Using the Macy Catheter in Reducing Pain in Patients With Advanced Cancer
NCT ID: NCT03592459
Last Updated: 2020-11-16
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2018-08-08
2020-01-15
Brief Summary
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Detailed Description
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I. Determine the feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care.
SECONDARY OBJECTIVES:
I. To determine the ease of use, level of satisfaction and overall perception of effectiveness of 'Macy catheter' for rectal administration of opioids for pain control in advanced cancer patients, by the hospital bedside nursing staff.
II. To assess patients' (or primary care-giver's) experience of using the 'Macy catheter' 48 hours after discharge from the hospital.
III. To assess the hospice staff (or primary care-giver's) experience of using the 'Macy catheter' after patient's death.
OUTLINE:
Patients undergo placement of rectal catheter and receive opioids through the Macy catheter.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Device feasibility (Macy catheter, opioids)
Patients undergo placement of rectal catheter and receive opioids through the Macy catheter.
Macy Catheter
Undergo placement of Macy catheter
Pain Therapy
Receive opioids via Macy catheter
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Macy Catheter
Undergo placement of Macy catheter
Pain Therapy
Receive opioids via Macy catheter
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidate for taking short acting opioids and/or methadone, with or without transdermal fentanyl, for control of cancer related pain
* Impaired oral/gastrointestinal (GI) route for medicine intake (due to, but not limited to, any level of gastrointestinal obstruction, severe nausea and/or vomiting, odynophagia and/or dysphagia due to severe mucositis, tumor, muscle weakness or in-coordination)
* Advanced cancer defined as cancer with no further oncological management and patients are at end of life (EOL) or recommended for best supportive/comfort care (estimated prognosis less than 6 months)
* Able and willing to read and sign in English
Exclusion Criteria
* Contraindications to use of the Macy catheter (1. Not be used for patients with rectal lesions, tumors, active rectal bleeding and/or compromised rectal mucosa \[i.e. ulceration or ischemic proctitis\], 2. Patients with diarrhea, or more than 1 liquid stool per day, 3. Patients with recent bowel surgery \[less than 6 weeks\], 4. Thrombocytopenia \[platelet count less than 20,000, checked in the last 1 week\])
* Patients who are unable to take oral medications due to severe constipation only, which can be adequately managed by bowel laxative regimen
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ahsan Azhar
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-01344
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0321
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0321
Identifier Type: -
Identifier Source: org_study_id