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

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ClinicalTrials.gov Identifier: NCT03592459
Recruitment Status : Withdrawn (Study halted prematurely, prior to enrollment of first participant)
First Posted : July 19, 2018
Last Update Posted : November 16, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Pain Device: Macy Catheter Procedure: Pain Therapy Other: Questionnaire Administration Other: Survey Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Rectal Administration of Opioids for Comfort Care in Advanced Cancer Patients Using the Macy Catheter
Actual Study Start Date : August 8, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 15, 2020

Arm Intervention/treatment
Experimental: Device feasibility (Macy catheter, opioids)
Patients undergo placement of rectal catheter and receive opioids through the Macy catheter.
Device: Macy Catheter
Undergo placement of Macy catheter

Procedure: Pain Therapy
Receive opioids via Macy catheter
Other Names:
  • analgesia
  • Pain Control
  • Pain Management
  • Pain, Pain Management

Other: Questionnaire Administration
Ancillary studies

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  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 [ Time Frame: Up to 1 year ]
    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.


Secondary Outcome Measures :
  1. Episodes of confusion (delirium) assessed by primary caregiver survey [ Time Frame: Up to 1 year ]
  2. Hospice nurse experience assessed by survey [ Time Frame: Up to 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03592459


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ahsan Azhar M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03592459    
Other Study ID Numbers: 2018-0321
NCI-2018-01344 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0321 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms