Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alberta Health Services
• Collaborator: University of Alberta
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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