Recruiting PHASE2 Pancreatic Cancer Non-resectable

New treatment option for Pancreatic Cancer Non-resectable

Official title Medical Cannabis in Patients With Advanced Pancreatic and Colorectal Cancer

ClinicalTrials.gov ID: NCT06605430

What this study is testing

What is Medical Cannabis?

Medical Cannabis is an investigational medicine, given as an once-weekly, being studied as a potential treatment for pancreatic cancer non-resectable.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Many patients with advanced pancreatic cancer and colorectal cancer experience burdensome and difficult-to-treat symptoms. The impact of multiple symptoms (called "symptom burden") can negatively affect a patient's quality of life, decrease their ability to tolerate cancer treatments, and lead to worse survival.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Adults (aged 18 or more at enrollment)
  • Histologically or cytologically proven pancreatic or colorectal cancer. Histologies may include listing of adenocarcinoma, poorly differentiated...
  • Advanced stage (locally advanced or metastatic) pancreatic or colorectal cancer with no definitive plans for curative surgery in the next 3 months
  • Self-report of experiencing nausea, vomiting, anorexia, cachexia (wasting), or pain at least once in the 14 days prior to randomization
  • Plan to initiate or initiated within the past 2 weeks standard-of-care systemic chemotherapy (any regimen that does not include immunotherapy) at a...

You likely can't join if

  • Self-reported regular use (using 10 or more days in the 30 days prior to randomization) of a THC containing cannabinoid product
  • Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis)
  • Patients with Alzheimer's dementia, active epilepsy, or history of traumatic brain injury
  • Patients with known active or untreated brain metastases. A brain MRI is not required during the screening period.
  • Patients initiating or receiving immunotherapy, a chemotherapy-immunotherapy combination, or non-standard cytotoxic chemotherapy (including patients...
  • Women who are pregnant, breastfeeding or of childbearing potential without the use of birth control
See the full eligibility criteria
Who can join
  • Adults (aged 18 or more at enrollment)
  • Histologically or cytologically proven pancreatic or colorectal cancer. Histologies may include listing of adenocarcinoma, poorly differentiated carcinoma, or other pathology terms that treating oncologist would...
  • Advanced stage (locally advanced or metastatic) pancreatic or colorectal cancer with no definitive plans for curative surgery in the next 3 months
  • Self-report of experiencing nausea, vomiting, anorexia, cachexia (wasting), or pain at least once in the 14 days prior to randomization
  • Plan to initiate or initiated within the past 2 weeks standard-of-care systemic chemotherapy (any regimen that does not include immunotherapy) at a participating institution with no prior systemic therapy in the prior 3...
  • Must be a resident of Minnesota
  • Must be willing to be registered in the Minnesota Medical Cannabis Program and follow all rules and requirements of the state program
  • Must be willing to report baseline and required patient-reported outcomes
What rules you out
  • Self-reported regular use (using 10 or more days in the 30 days prior to randomization) of a THC containing cannabinoid product
  • Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis)
  • Patients with Alzheimer's dementia, active epilepsy, or history of traumatic brain injury
  • Patients with known active or untreated brain metastases. A brain MRI is not required during the screening period.
  • Patients initiating or receiving immunotherapy, a chemotherapy-immunotherapy combination, or non-standard cytotoxic chemotherapy (including patients enrolled/ enrolling in trials of investigational cancer-directed...
  • Women who are pregnant, breastfeeding or of childbearing potential without the use of birth control
  • Uncontrolled acute or chronic medical conditions, psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may...
  • Has any condition that in the opinion of the investigator might jeopardize the safety of the subject or interfere with protocol compliance

The study team makes the final eligibility decision.

Where it's taking place

  • Saint Louis Park, Minnesota, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Saint Louis Park, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.