Cancer PainNCT05674240
Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain
An observational study of Cancer Pain and Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer Pain, Chronic Pain, Cancer Associated Pain
- What is being tested?
- Intrathecal Targeted Drug Delivery and Conservative medical management
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 20 Mar 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 169 subjects with cancer-associated pain who are going to be treated either with conservative medical management (CMM) only or with Intrathecal Drug Delivery along with CMM per treatment plan.
Who may be able to join
- 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
Who cannot join
- Active infections
- Controlled pain without adverse side effects that are limiting day to day function
- Mechanical barriers
- Obstruction of Cerebrospinal Fluid (CSF)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Targeted Drug Delivery for Cancer Associated Pain
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.
Read the detailed 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- and 6- months post-implant.
- Conditions
- Cancer Pain, Chronic Pain, Cancer Associated Pain, Neuropathic Pain
- Being tested
- Intrathecal Targeted Drug Delivery, Conservative medical management
- Keywords
- targeted drug delivery, cancer pain, conservative pain management, neuromodulation, opioid, healthcare-utilization, quality of life
- Medical subject headings
- Cancer Pain, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Targeted Drug DeliveryDevice
Also called Medtronic SynchroMed™ II pump
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
Conservative medical managementCombination product
Including physical therapy, oral or transdermal medications and injections
| Study group | Role | What they receive |
|---|---|---|
| Cancer associated pain treated with conservative medical management (CMM) only | 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 Receives: Combination Product: Conservative medical management | |
| Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM | Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain Receives: Device: Intrathecal Targeted Drug Delivery; Combination Product: Conservative medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3-Months
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)
Measured: 3-Months
Secondary outcomes (5)
Change in Drug Adverse Levels
Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria
Measured: 3-Months
Change in Oral Opioid Intake
Average change from baseline to 3-Months in oral opioid intake
Measured: 3-Months
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
Measured: 3-Months
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)
Measured: 3-Months
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)
Measured: 3-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start6 Dec 2022
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Littlefield, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674240
- Sponsor's protocol ID
- IRB00104840
- Status last verified
- Mar 2026
- First submitted
- 14 Dec 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Targeted Drug Delivery for Cancer Associated Pain
- ClinicalTrials.gov ID
- NCT05674240
- Acronym / sponsor ID
- IRB00104840
- Conditions
- Cancer Pain, Chronic Pain, Cancer Associated Pain, Neuropathic Pain
- Keywords
- targeted drug delivery, cancer pain, conservative pain management, neuromodulation, opioid, healthcare-utilization, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 6 Jan 2023 (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 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.
Detailed 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- and 6- months post-implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer associated pain treated with conservative medical management (CMM) only | – | Combination Product: Conservative medical managementSubjects 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 |
| Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM | – | Device: Intrathecal Targeted Drug Delivery, Combination Product: Conservative medical managementPatients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 169 subjects with cancer-associated pain who are going to be treated either with conservative medical management (CMM) only or with Intrathecal Drug Delivery along with CMM per treatment plan.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Active infections
- Controlled pain without adverse side effects that are limiting day to day function
- Mechanical barriers
- Obstruction of Cerebrospinal Fluid (CSF)
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 |
|---|---|---|
| Intrathecal Targeted Drug DeliveryAlso: Medtronic SynchroMed™ II pumpIntrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord. | Device | Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM |
| Conservative medical managementIncluding physical therapy, oral or transdermal medications and injections | Combination product | Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM, Cancer associated pain treated with conservative medical management (CMM) only |
Primary outcome
Change in Pain Intensity from Screening through 3-Months
Time frame: 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)
Change in Pain Interference from Screening through 3-Months
Time frame: 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)
5 secondary outcomes
Change in Drug Adverse Levels
Time frame: 3-Months
Change in Oral Opioid Intake
Time frame: 3-Months
Change in Healthcare Utilization
Time frame: 3-Months
Change in Patient Well-Being
Time frame: 3-Months
Change in Patient Global Impression Change
Time frame: 3-Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lauren Littlefield, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain and Chronic Pain, run by Wake Forest University Health Sciences 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 27 Mar 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pain Intensity from Screening through 3-Months (time frame: 3-Months). The study lists 2 primary outcomes in all. 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 27 Mar 2026.