Advanced Malignant NeoplasmNCT03592459
Rectal Administration of Opioids Using the Macy Catheter in Reducing Pain in Patients With Advanced Cancer
A study testing Macy Catheter, Pain Therapy and Questionnaire Administration in people with Advanced Malignant Neoplasm and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm, Pain
- What is being tested?
- Macy Catheter, Pain Therapy and Questionnaire Administration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Advanced Malignant Neoplasm, Pain
- Being tested
- Macy Catheter, Pain Therapy, Questionnaire Administration, Survey Administration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macy CatheterDevice
Undergo placement of Macy catheter
Pain TherapyProcedure or surgery
Also called analgesia, Pain Control, Pain Management, Pain, Pain Management
Receive opioids via Macy catheter
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Device feasibility (Macy catheter, opioids) | Experimental | Patients undergo placement of rectal catheter and receive opioids through the Macy catheter. Receives: Device: Macy Catheter; Procedure: Pain Therapy; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (2)
Episodes of confusion (delirium) assessed by primary caregiver survey
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start8 Aug 2018
- Primary completion31 Dec 2019
- Study completion15 Jan 2020
Why it stopped: Study halted prematurely, prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ahsan Azhar, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592459
- Sponsor's protocol ID
- 2018-0321
- Other IDs
- NCI-2018-01344, 2018-0321, P30CA016672
- Status last verified
- Nov 2020
- First submitted
- 5 Jul 2018
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Administration of Opioids for Comfort Care in Advanced Cancer Patients Using the Macy Catheter
- ClinicalTrials.gov ID
- NCT03592459
- Acronym / sponsor ID
- 2018-0321
- Conditions
- Advanced Malignant Neoplasm, Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the feasibility of using the device 'Macy catheter' for rectal administration of opioids for comfort in cancer patients on palliative care.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (Macy catheter, opioids) | Experimental | Device: Macy Catheter, Procedure: Pain Therapy, Other: Questionnaire Administration, Other: Survey AdministrationPatients undergo placement of rectal catheter and receive opioids through the Macy catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macy CatheterUndergo placement of Macy catheter | Device | Device feasibility (Macy catheter, opioids) |
| Pain TherapyAlso: analgesia, Pain Control, Pain Management, Pain, Pain ManagementReceive opioids via Macy catheter | Procedure or surgery | Device feasibility (Macy catheter, opioids) |
| Questionnaire AdministrationAncillary studies | Other | Device feasibility (Macy catheter, opioids) |
| Survey AdministrationAncillary studies | Other | Device feasibility (Macy catheter, opioids) |
Primary outcome
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.
2 secondary outcomes
Episodes of confusion (delirium) assessed by primary caregiver survey
Time frame: Up to 1 year
Hospice nurse experience assessed by survey
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Advanced Malignant Neoplasm
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahsan Azhar principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macy Catheter, Pain Therapy and Questionnaire Administration in people with Advanced Malignant Neoplasm and Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.