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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316563
• Other study ID #: PS-8-0008
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2006
• Last updated: February 8, 2010
• Start date: August 2006
• Est. completion date: November 2009

Study information

• Verified date: November 2007
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia
• Cancer
• Disease
• Olfactory Disorders
• Taste Disorders

Intervention

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

Other:
• Placebo

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services	University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total caloric intake		22 days
Secondary	self-perceived chemosensory ability		22 days
Secondary	palatable food intake		22 days
Secondary	self-perceived appetite		22 days
Secondary	changes in nausea		22 days
Secondary	safety and tolerability		22 days