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

Sponsor:	Alberta Health Services
Collaborator:	University of Alberta
Information provided by:	Alberta Health Services
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

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:

MedlinePlus related topics: Cancer Taste and Smell Disorders

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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

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

Alberta Health Services

University of Alberta

Investigators

Principal Investigator:

Ingrid H. de Kock, MD

Alberta Health Services

More Information

Publications:

DeWys WD, Walters K. Abnormalities of taste sensation in cancer patients. Cancer. 1975 Nov;36(5):1888-96.

Jatoi A, Windschitl HE, Loprinzi CL, Sloan JA, Dakhil SR, Mailliard JA, Pundaleeka S, Kardinal CG, Fitch TR, Krook JE, Novotny PJ, Christensen B. Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: a North Central Cancer Treatment Group study. J Clin Oncol. 2002 Jan 15;20(2):567-73.

Nelson K, Walsh D, Deeter P, Sheehan F. A phase II study of delta-9-tetrahydrocannabinol for appetite stimulation in cancer-associated anorexia. J Palliat Care. 1994 Spring;10(1):14-8. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brisbois TD, de Kock IH, Watanabe SM, Mirhosseini M, Lamoureux DC, Chasen M, MacDonald N, Baracos VE, Wismer WV. Delta-9-tetrahydrocannabinol may palliate altered chemosensory perception in cancer patients: results of a randomized, double-blind, placebo-controlled pilot trial. Ann Oncol. 2011 Sep;22(9):2086-93. Epub 2011 Feb 22.

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 Alberta Health Services:

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 February 09, 2012