Clinical trial NCT03592459: Rectal Administration of Opioids Using the Macy Catheter in Reducing Pain in Patients With Advanced Cancer
Official title: Rectal Administration of Opioids for Comfort Care in Advanced Cancer Patients Using the Macy Catheter
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Advanced Malignant Neoplasm
Pain
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This trial studies how well rectal administration of opioids using the Macy catheter works in reducing pain in patients 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 patients with smoother transition out of hospital.

Detailed description: 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:

Patients undergo placement of rectal catheter and receive opioids through the Macy catheter.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the inpatient Acute Palliative Care Unit (APCU) at MD Anderson Cancer Center
* 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:

* Non-English speaking
* 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

Primary outcomes:
measure: Feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care as defined by number of doses administered and patient satisfaction
timeFrame: Up to 1 year
Secondary outcomes:
measure: Episodes of confusion (delirium) assessed by primary caregiver survey
timeFrame: Up to 1 year
measure: Hospice nurse experience assessed by survey
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ahsan Azhar
role: PRINCIPAL_INVESTIGATOR
References: