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

This study has been completed.
Sponsor:
Collaborator:
University of Alberta
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00316563
First received: April 19, 2006
Last updated: February 8, 2010
Last verified: November 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

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
Study Completion Date: November 2009
Arms Assigned Interventions
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
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
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, see Learn About Clinical Studies.

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

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
AHS Cancer Control Alberta
University of Alberta
Investigators
Principal Investigator: Ingrid H. de Kock, MD AHS Cancer Control Alberta
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00316563     History of Changes
Other Study ID Numbers: PS-8-0008
Study First Received: April 19, 2006
Last Updated: February 8, 2010
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
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

Additional relevant MeSH terms:
Congenital Abnormalities
Anorexia
Taste Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014