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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316563
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : February 9, 2010
University of Alberta
Information provided by:
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment Phase
Cancer Anorexia Taste Disorders Olfactory Disorders Drug: Marinol (Dronabinol) Other: Placebo Phase 2

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 sensory abnormalities, as a person who is experiencing food aversion due to taste and smell changes may be unable to respond to these agents. Of the appetite stimulants available for use in clinical practice only Marinol, or THC, has the potential to increase food intake by improving appetite as well as by amplifying the taste of food through the brain's reward pathway.

A 22-day, double blind, randomized, placebo-controlled trial will be conducted. Participants will start at 2.5mg of THC or placebo once daily for the first 3 days and then increase to 2.5mg of THC or placebo twice daily before lunch and supper. Participant's will complete the following survey tools pre and post-treatment: Taste and Smell Survey to assess the severity and change in chemosensory complaint scores; 3-day dietary record to determine the change in caloric intake and shift in food preference by macronutrient analysis; 24-hour urine collections to validate the 3-day dietary record; Satiety Labelled Intensity Magnitude scale for subjective appetite ratings; Food Preference Checklist to assess objective shifts in macronutrient and flavor preferences; Functional Assessment of Anorexia/Cachexia Therapy questionnaire to assess participant's QOL; interview to determine the cause and effects of chemosensory alterations; Edmonton Symptom Assessment Scale to assess nausea; and Side Effect Survey to document the tolerability of the drug (post-treatment only). Participants will complete the survey tools with the aid of the researcher. All tools are short and easy to complete, which minimizes patient burden.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy of Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study
Study Start Date : August 2006
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Active Comparator: 1 Drug: Marinol (Dronabinol)
Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.

Placebo Comparator: 2 Other: Placebo

Primary Outcome Measures :
  1. Total caloric intake [ Time Frame: 22 days ]

Secondary Outcome Measures :
  1. self-perceived chemosensory ability [ Time Frame: 22 days ]
  2. palatable food intake [ Time Frame: 22 days ]
  3. self-perceived appetite [ Time Frame: 22 days ]
  4. changes in nausea [ Time Frame: 22 days ]
  5. safety and tolerability [ Time Frame: 22 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00316563

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Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Alberta Health Services
University of Alberta
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Principal Investigator: Ingrid H. de Kock, MD AHS Cancer Control Alberta
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00316563    
Other Study ID Numbers: PS-8-0008
First Posted: April 21, 2006    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: November 2007
Keywords provided by AHS Cancer Control Alberta:
taste disorders
olfaction disorders
palliative medicine
caloric intake
tetrahydrocannabinol/therapeutic use
anorexia/drug therapy
quality of life
chemosensory changes/drug therapy
Additional relevant MeSH terms:
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Taste Disorders
Pathologic Processes
Signs and Symptoms, Digestive
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists