Nervous System Diseases

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Neuralgia

Cancer Pain

Chronic Pain

Pain

Neurologic Manifestations

Peripheral Nervous System Diseases

Neuromuscular Diseases

Quality of Life

Chronic Graft Versus Host Disease

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Analgesics, Opioid

Subjects in this group are patients who opted for conservative medical management for their chronic pain that is cancer associated, including physical therapy, oral or transdermal medications and injections

Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain

Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.

Intrathecal Targeted Drug Delivery

Including physical therapy, oral or transdermal medications and injections

Conservative medical management

Mansoor M Aman, MD

Merve B Figueira, MS

Vishal M Patel, MD

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.

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.

Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

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)

Change from baseline to 2-Months post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Average change from baseline to 2-Months in drug adverse levels as assessed through the Common Toxicity Criteria

Average change from baseline to 2-Months in oral opioid intake

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)

Average change from baseline to 2-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

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)

Change from baseline to 1-Month post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Average change from baseline to 1-Month in drug adverse levels as assessed through the Common Toxicity Criteria

Average change from baseline to 1-Month in oral opioid intake

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)

Average change from baseline to 1-Month in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

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)

Change from baseline to Month 3 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)

Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria

Average change from baseline to 3-Months in oral opioid intake

Average change from baseline to 3-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain

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)

Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain	NCT05674240	Cancer Pain Chronic Pain Cancer Associat... Neuropathic Pai...	Intrathecal Tar... Conservative me...	21 Years -	Aurora Health Care
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain	NCT05674240	Cancer Pain Chronic Pain Cancer Associat... Neuropathic Pai...	Intrathecal Tar... Conservative me...	21 Years -	Aurora Health Care
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain	NCT05674240	Cancer Pain Chronic Pain Cancer Associat... Neuropathic Pai...	Intrathecal Tar... Conservative me...	21 Years -	Aurora Health Care

Spots Global Cancer Trial Database for intrathecal targeted drug delivery