Beta
Trial Radar KI
enums.trial_summary.trial_summary_welcome
Eine Studie entspricht den Filterkriterien
Kartenansicht
Zurück zur Suche

Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Aktiv, nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05674240 ist eine beobachtungsstudie zur Untersuchung von Krebsschmerz, Chronische Schmerzen, Cancer Associated Pain, Neuropathischer Schmerz und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 6. Dezember 2022 und soll 30 Teilnehmer aufnehmen. Durchgeführt von Wake Forest University ist der Abschluss für 20. Januar 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 18. Juli 2025 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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.

Offizieller Titel

Intrathecal Targeted Drug Delivery for Cancer Associated Pain

Erkrankungen
KrebsschmerzChronische SchmerzenCancer Associated PainNeuropathischer Schmerz
Weitere Studien-IDs
  • IRB00104840
NCT-Nummer
NCT05674240
Studienbeginn (tatsächlich)
2022-12-06
Zuletzt aktualisiert
2025-07-18
Studienende (vorauss.)
2026-01-20
Geplante Rekrutierung
30
Studientyp
Beobachtungsstudie
Status
Aktiv, nicht rekrutierend
Stichwörter
targeted drug delivery
cancer pain
conservative pain management
neuromodulation
opioid
healthcare-utilization
quality of life
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
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
Conservative Medical Management
Including physical therapy, oral or transdermal medications and injections
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
Intrathecal Targeted Drug Delivery
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
Conservative Medical Management
Including physical therapy, oral or transdermal medications and injections
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Change in Oral Opioid Intake
Average change from baseline to 3-Months in oral opioid intake
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
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)
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)
3-Months
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
21 Years
Zugelassene Geschlechter
Alle
  • 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

  • Active infections
  • Controlled pain without adverse side effects that are limiting day to day function
  • Mechanical barriers
  • Obstruction of Cerebrospinal Fluid (CSF)
Wake Forest University Health Sciences logoWake Forest University323 aktive klinische Studien zum Erkunden
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

Wisconsin

Advocate Aurora Health, Oshkosh, Wisconsin, 54904, United States