Clinical trial · Interventional
Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study
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
NCT00316563CI-TRIAL-00003127completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Olfactory Disorders | — | UNRESOLVED | — |
| Taste Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Marinol (Dronabinol) | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Marinol (Dronabinol)
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Total caloric intake
- timeFrame
- 22 days
Secondary outcomes (5)
- measure
- self-perceived chemosensory ability
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDDeWys 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 1192373
- BACKGROUNDJatoi 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 11786587
- BACKGROUNDNelson 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 8035251
- DERIVEDBrisbois 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 21343383