NCT00316563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 9, 2010

Status Verified

November 1, 2007

First QC Date

April 19, 2006

Last Update Submit

February 8, 2010

Conditions

CancerAnorexiaTaste DisordersOlfactory Disorders

Keywords

cannabinoidstaste disordersolfaction disorderscancerpalliative medicinecaloric intakeappetiterewardtetrahydrocannabinol/therapeutic useanorexia/drug therapyquality of lifechemosensory changes/drug therapy

Outcome Measures

Primary Outcomes (1)

  • Total caloric intake

    22 days

Secondary Outcomes (5)

  • self-perceived chemosensory ability

    22 days

  • palatable food intake

    22 days

  • self-perceived appetite

    22 days

  • changes in nausea

    22 days

  • safety and tolerability

    22 days

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Marinol (Dronabinol)

2

PLACEBO COMPARATOR
Other: Placebo

Interventions

Marinol (Dronabinol)DRUG

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

1
PlaceboOTHER
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (4)

  • 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.

    PMID: 1192373BACKGROUND

  • 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.

    PMID: 11786587BACKGROUND

  • 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.

    PMID: 8035251BACKGROUND

  • 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.

    PMID: 21343383DERIVED

MeSH Terms

Conditions

NeoplasmsAnorexiaTaste DisordersOlfaction Disorders

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Ingrid H. de Kock, MD

    AHS Cancer Control Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2006

First Posted

April 21, 2006

Study Start

August 1, 2006

Study Completion

November 1, 2009

Last Updated

February 9, 2010

Record last verified: 2007-11

Locations

CA(2)