Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605430
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Medical Cannabis in Patients With Advanced Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Phase II Trial of Medical Cannabis to Reduce Symptom Burden in Patients With Advanced Pancreatic Cancer CanPan Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CanPan
Brief Summary:
Many patients with Pancreatic Ductal Adenocarcinoma PDAC experience burdensome and difficult-to-treat symptoms The impact of multiple symptoms called symptom burden can negatively affect a patients quality of life decrease their ability to tolerate cancer treatments and lead to worse survival Current approaches to manage PDAC-associated symptoms often work poorly with most patients reporting a moderate to severe symptom burden Therefore there is an urgent need for treatments that improve these symptoms in patients with PDAC and data suggests that medical cannabis can help In this research study we are examining the usefulness of using medical cannabis in patients with pancreatic cancer to further study how cannabis can impact their symptom burden
Detailed Description:
Participants will be randomized 11 to receive early or delayed medical cannabis The early group will have access to medical cannabis immediately at no charge while the delayed group will agree not to use cannabis of any type during the first 8 weeks The primary study period for assessing the primary aim is 0 - 8 weeks Participants in the early arm will then have an option to receive cannabis at no charge for another 8 weeks total 16 weeks Participants in the delayed arm will receive cannabis from weeks 8 to 16 at no charge This secondary study period 8-16 weeks will be used to assess the proportion of participants in the early arm who choose to continue cannabis persistence of symptom relief with cannabis and ongoing safety signals Patients in the delayed group will complete patient-reported outcomes using NCI PRO-CTCAE PRO weekly and PROMIS Global QOL every 4 weeks through 16 weeks Patients in the early group will complete PRO weekly and QOL every 4 weeks through week 8 then PROQOL every 4 weeks until week 16 All patients will complete a close out survey at the end of their cannabis administration period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None