Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Chronic Pain Clinical Trial

Official title:

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674240
• Other study ID #: 22-820
• Status: Recruiting
• Start date: December 6, 2022
• Est. completion date: December 6, 2025

Study information

• Verified date: January 2024
• Source: Aurora Health Care
• Contact: Mansoor M Aman, MD
• Phone: 9204564030
• Email: mansoor.aman[@]aah.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.

Description:

This is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. Subjects with cancer associated pain who are receiving conservative medical management (CMM) only and cancer patients receiving Intrathecal Drug Delivery system (IDDs) along with CMM will be followed for up to 3 months. Subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the IDDs group and start of the new treatment plan for the CMM group. Subjects that decide to cross-over to the IDDs group in a future date, will still be followed for their progress.

Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3 months post-implant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 169
• Est. completion date: December 6, 2025
• Est. primary completion date: June 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Age of 21 and older

• Uncontrolled cancer-associated pain (pain score of >5 on NRS) despite oral use of 60 mg/d morphine equivalent a week prior to screening

• Adverse side effects from long term opioid use defined as limiting or severely affecting patient's day to day function

• Life expectancy of > 3 months

Exclusion Criteria:

• Active infections

• Controlled pain without adverse side effects that are limiting day to day function

• Mechanical barriers

• Obstruction of Cerebrospinal Fluid (CSF)

Related Conditions & MeSH terms

• Cancer Pain
• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Intrathecal Targeted Drug Delivery
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.

Combination Product:
• Conservative medical management
Including physical therapy, oral or transdermal medications and injections

Locations

Country	Name	City	State
United States	Advocate Aurora Health	Oshkosh	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mansoor Aman, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Pain Intensity	Change from baseline to 2-Months post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)	2-Months
Other	Change in Pain Interference	Change from baseline to 2-Months post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)	2-Months
Other	Change in Drug Adverse Levels	Average change from baseline to 2-Months in drug adverse levels as assessed through the Common Toxicity Criteria	2-Months
Other	Change in Oral Opioid Intake	Average change from baseline to 2-Months in oral opioid intake	2-Months
Other	Change in Patient Well-Being	Average change from baseline to 2-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)	2-Months
Other	Change in Patient Global Impression Change	Average change from baseline to 2-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)	2-Months
Other	Change in Pain Intensity	Change from baseline to 1-Month post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)	1-Month
Other	Change in Pain Interference	Change from baseline to 1-Month post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)	1-Month
Other	Change in Drug Adverse Levels	Average change from baseline to 1-Month in drug adverse levels as assessed through the Common Toxicity Criteria	1-Month
Other	Change in Oral Opioid Intake	Average change from baseline to 1-Month in oral opioid intake	1-Month
Other	Change in Patient Well-Being	Average change from baseline to 1-Month in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)	1-Month
Other	Change in Patient Global Impression Change	Average change from baseline to 1-Month in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)	1-Month
Other	Average change from baseline to 6-Months in drug adverse levels as assessed through the Common Toxicity Criteria (NCI)		6-Months
Other	Average change from baseline to 6-Months in oral opioid intake		6-Months
Other	Average change from baseline to 6-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain and length of hospital stays		6-Months
Other	Average change from baseline to 6-Months in patient well being as measured through FACT-G questionnaire		6-Months
Other	Overall patient satisfaction in 6-Months as assessed through PGIC questionnaire		6-Months
Primary	Change in Pain Intensity from Screening through 3-Months	Change from baseline to Month 3 post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)	3-Months
Primary	Change in Pain Interference from Screening through 3-Months	Change from baseline to Month 3 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)	3-Months
Secondary	Change in Drug Adverse Levels	Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria	3-Months
Secondary	Change in Oral Opioid Intake	Average change from baseline to 3-Months in oral opioid intake	3-Months
Secondary	Change in Healthcare Utilization	Average change from baseline to 3-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain	3-Months
Secondary	Change in Patient Well-Being	Average change from baseline to 3-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)	3-Months
Secondary	Change in Patient Global Impression Change	Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)	3-Months