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

Primary Purpose

Cancer, Anorexia, Taste Disorders

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Marinol (Dronabinol)
Placebo
Sponsored by
Alberta Health services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cross Cancer Institute
  • Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Total caloric intake

Secondary Outcome Measures

self-perceived chemosensory ability
palatable food intake
self-perceived appetite
changes in nausea
safety and tolerability

Full Information

First Posted
April 19, 2006
Last Updated
February 8, 2010
Sponsor
Alberta Health services
Collaborators
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT00316563
Brief Title
Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Alberta Health services
Collaborators
University of Alberta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Anorexia, Taste Disorders, Olfactory Disorders
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Marinol (Dronabinol)
Intervention Description
Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Total caloric intake
Time Frame
22 days
Secondary Outcome Measure Information:
Title
self-perceived chemosensory ability
Time Frame
22 days
Title
palatable food intake
Time Frame
22 days
Title
self-perceived appetite
Time Frame
22 days
Title
changes in nausea
Time Frame
22 days
Title
safety and tolerability
Time Frame
22 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid H. de Kock, MD
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
1192373
Citation
DeWys WD, Walters K. Abnormalities of taste sensation in cancer patients. Cancer. 1975 Nov;36(5):1888-96. doi: 10.1002/1097-0142(197511)36:53.0.co;2-y.
Results Reference
background
PubMed Identifier
11786587
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. doi: 10.1200/JCO.2002.20.2.567.
Results Reference
background
PubMed Identifier
8035251
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.
Results Reference
background
PubMed Identifier
21343383
Citation
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):2086-2093. doi: 10.1093/annonc/mdq727. Epub 2011 Feb 22.
Results Reference
derived

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

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