Rectal Administration of Opioids Using the Macy Catheter in Reducing Pain in Patients With Advanced Cancer

NCT03592459 | Withdrawn

• 3 other identifiers: 2018-0321NCI-2018-01344P30CA016672
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Neoplasm; Pain

Outcome Measures

Primary Outcomes (1)

• 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

  Will be assessed by the number of doses that a patient finishes (at least 4 out of 6 doses administered) and by asking patients' about their level of satisfaction and overall perception of effectiveness of using the device, collected by question 10 and 11 in the survey, respectively. The association between patients' demographics and clinical characteristics and patients' satisfaction and perception of effectiveness will be evaluated by Wilcoxon rank sum test and chi-square (or Fisher's exact) test for continuous and categorical variables, respectively. In order to address the primary objective, the feasibility rate will be estimated and reported along with a 95% Clopper-Pearson exact confidence interval.

  Up to 1 year

Secondary Outcomes (2)

• Episodes of confusion (delirium) assessed by primary caregiver survey

  Up to 1 year

• Hospice nurse experience assessed by survey

  Up to 1 year

Study Arms (1)

Device feasibility (Macy catheter, opioids)

EXPERIMENTAL

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

Device: Macy Catheter; Procedure: Pain Therapy; Other: Questionnaire Administration; Other: Survey Administration

Interventions

Macy Catheter DEVICE

Undergo placement of Macy catheter

Device feasibility (Macy catheter, opioids)

Pain Therapy PROCEDURE

Receive opioids via Macy catheter

Also known as: analgesia, Pain Control, Pain Management, Pain, Pain Management

Device feasibility (Macy catheter, opioids)

Questionnaire Administration OTHER

Ancillary studies

Device feasibility (Macy catheter, opioids)

Survey Administration OTHER

Ancillary studies

Device feasibility (Macy catheter, opioids)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pain

Interventions

Analgesia; Pain Management

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Study Officials

• Ahsan Azhar

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 19, 2018
• Study Start: August 8, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 15, 2020
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

US (1)