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
Verified date | November 2007 |
Source | AHS Cancer Control Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | November 2009 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Royal Victoria Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Alberta Health Services | University of Alberta |
Canada,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|