Status:
COMPLETED
Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study
Lead Sponsor:
Alberta Health services
Collaborating Sponsors:
University of Alberta
Conditions:
Cancer
Anorexia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory) abnormalities.
Detailed Description
Appetite stimulants are the common treatment for cancer-induced anorexia. However, only 30% of advanced cancer patients respond and benefit from appetite stimulants, which may be due in part to sensor...
Eligibility Criteria
Inclusion
- advanced cancer patients (defined as locally recurrent or metastatic) over 18 years old with a decreased food intake for at least 2 weeks (reported by physician or subject)
- able to complete questionnaires in English
- able to provide informed consent
- life expectancy of greater than 2 months (as determined by physician)
- chemosensory complaint score \> 1
Exclusion
- receiving enteral or parenteral feedings
- allergies or sensitivity to THC and/or sesame seed oil
- history of substance abuse or psychotic episodes
- mechanical obstruction of alimentary tract, mouth or nose
- received chemotherapy in the last 2 weeks
- received radiation therapy to the head/neck area
- brain tumor
- nausea score greater than 5 on ESAS
- history of tachyarrhythmias, angina pectoris or hypertension
- current diagnosis of liver impairment
- use of marijuana within 30 days prior to start of trial
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00316563
Start Date
August 1 2006
End Date
November 1 2009
Last Update
February 9 2010
Active Locations (2)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
2
Royal Victoria Hospital
Montreal, Quebec, Canada, H2W 1S6