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

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 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.

Study Overview

• Status: Withdrawn
• Conditions: Pain; Advanced Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survey Administration; Device: Macy Catheter; Procedure: Pain Therapy

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device feasibility (Macy catheter, opioids); Patients undergo placement of rectal catheter and receive opioids through the Macy catheter.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Device: Macy Catheter; Undergo placement of Macy catheter; Procedure: Pain Therapy; Receive opioids via Macy catheter; Other Names: Pain Control; Pain Management; Pain, Pain Management; analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of confusion (delirium) assessed by primary caregiver survey		Up to 1 year
Hospice nurse experience assessed by survey	Will be summarized by frequency tables. McNemar's test will be applied to evaluate whether the feasibility changes from the time at the hospital to 48 hours of discharge. Other statistical methods may be applied when appropriate.	Up to 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2018
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2018-0321 (OTHER: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2018-01344 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No