Rectal Administration of Opioids Using the Macy Catheter in Reducing Pain in Participants With Advanced Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | August 8, 2018 |
| End Date: | December 31, 2020 |
Rectal Administration of Opioids for Comfort Care in Advanced Cancer Patients Using the Macy Catheter
This trial studies how well rectal administration of opioids using the Macy catheter work in
reducing pain in participants with cancer that has spread to other anatomic sites or is no
longer responding to treatment. Rectal administration of opioids using the Macy catheter may
help to reduce the cost of care, resolve the issue of medication availability currently faced
in the form of parenteral opioid shortage throughout the country, and provide adequate
comfort and symptom relief for participants with smoother transition out of hospital.
reducing pain in participants with cancer that has spread to other anatomic sites or is no
longer responding to treatment. Rectal administration of opioids using the Macy catheter may
help to reduce the cost of care, resolve the issue of medication availability currently faced
in the form of parenteral opioid shortage throughout the country, and provide adequate
comfort and symptom relief for participants with smoother transition out of hospital.
PRIMARY OBJECTIVES:
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:
Participants undergo placement of rectal catheter and receive opioids through the Macy
catheter.
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:
Participants undergo placement of rectal catheter and receive opioids through the Macy
catheter.
Inclusion Criteria:
- Adult patients admitted to the inpatient Acute Palliative Care Unit (APCU) at MD
Anderson Cancer Center
- On short acting opioids and/or methadone, with or without transdermal fentanyl, for
control of cancer related pain
- Impaired oral 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:
- Cognitive impairment with Memorial Delirium Assessment Scale (MDAS) score of 7 or more
as determined by palliative care clinician or research staff
- Non-English speaking
- Patient who are unable to or unwilling to sign written consent and survey
questionnaires
- 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
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Ahsan Azhar
Phone: 713-792-6085
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