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

This study is currently recruiting participants.
Verified by Alberta Cancer Board, November 2007

Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00316563
  Purpose

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 Intervention Phase
Cancer
Anorexia
Taste Disorders
Olfactory Disorders
Drug: Marinol (Dronabinol)
Other: Placebo
Phase II

MedlinePlus related topics:   Cancer    Taste and Smell Disorders   

ChemIDplus related topics:   Tetrahydrocannabinol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Alberta Cancer Board:

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

Secondary Outcome Measures:
  • self-perceived chemosensory ability [ Time Frame: 22 days ]
  • palatable food intake [ Time Frame: 22 days ]
  • self-perceived appetite [ Time Frame: 22 days ]
  • changes in nausea [ Time Frame: 22 days ]
  • safety and tolerability [ Time Frame: 22 days ]

Estimated Enrollment:   80
Study Start Date:   August 2006
Estimated Study Completion Date:   December 2008

Arms Assigned Interventions
1: Active Comparator Drug: Marinol (Dronabinol)
Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.
2: Placebo Comparator Other: Placebo
N/A

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316563

Contacts
Contact: Vickie Baracos, PhD     780-432-8232     vickieb@cancerboard.ab.ca    
Contact: Ingrid H. de Kock, MD     780-450-7934     idekock@cha.ab.ca    

Locations
Canada, Alberta
Cross Cancer Institute     Recruiting
      Edmonton, Alberta, Canada, T6G 1Z2
      Contact: Clinical Research Unit     780-989-8152     clinical_trials_cci@cancerboard.ab.ca    
      Principal Investigator: Ingrid H. de Kock, MD            

Sponsors and Collaborators
Alberta Cancer Board

Investigators
Principal Investigator:     Ingrid H. de Kock, MD     Alberta Cancer Board    
  More Information


Publications:

Study ID Numbers:   PS-8-0008
First Received:   April 19, 2006
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00316563
Health Authority:   Canada: Health Canada

Keywords provided by Alberta Cancer Board:
cannabinoids  
taste disorders  
olfaction disorders  
cancer  
palliative medicine  
caloric intake  
appetite
reward
tetrahydrocannabinol/therapeutic use
anorexia/drug therapy
quality of life
chemosensory changes/drug therapy

Study placed in the following topic categories:
Tetrahydrocannabinol
Sensation Disorders
Signs and Symptoms
Taste Disorders
Olfaction Disorders
Signs and Symptoms, Digestive
Anorexia
Quality of Life
Neurologic Manifestations
Congenital Abnormalities

Additional relevant MeSH terms:
Disease
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Hallucinogens
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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