CancerPhase 2NCT00316563
Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study
A Phase 2 study testing Marinol (Dronabinol) in people with Cancer and Anorexia, run by Alberta Health services at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Anorexia, Taste Disorders
- What is being tested?
- Marinol (Dronabinol)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2006to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Royal Victoria Hospital
Montreal, Quebec, H2W 1S6
About this 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
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.
Read the 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.
- Conditions
- Cancer, Anorexia, Taste Disorders, Olfactory Disorders
- Being tested
- Marinol (Dronabinol), Placebo
- 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
- Medical subject headings
- Neoplasms, Anorexia, Taste Disorders, Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marinol (Dronabinol)Drug
Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Marinol (Dronabinol) |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total caloric intake
Measured: 22 days
Secondary outcomes (5)
self-perceived chemosensory ability
Measured: 22 days
palatable food intake
Measured: 22 days
self-perceived appetite
Measured: 22 days
changes in nausea
Measured: 22 days
safety and tolerability
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startAug 2006
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Investigators
- Ingrid H. de Kock, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316563
- Sponsor's protocol ID
- PS-8-0008
- Status last verified
- Nov 2007
- First submitted
- 19 Apr 2006
- Last updated
- 9 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 1192373Jatoi 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.
PubMed 11786587Nelson 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.
PubMed 8035251Brisbois 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.
PubMed 21343383
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00316563
- Acronym / sponsor ID
- PS-8-0008
- Conditions
- Cancer, Anorexia, Taste Disorders, Olfactory Disorders
- Keywords
- cannabinoids, taste disorders, olfaction disorders, cancer, palliative medicine, caloric intake, appetite, reward
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- Aug 2006
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Marinol (Dronabinol) |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marinol (Dronabinol)Intervention description: Marinol (drug) is being used as an appetite stimulant for treatment of cancer-induced anorexia. | Drug | 1 |
| Placebo | Other | 2 |
Primary outcome
Total caloric intake
Time frame: 22 days
5 secondary outcomes
self-perceived chemosensory ability
Time frame: 22 days
palatable food intake
Time frame: 22 days
self-perceived appetite
Time frame: 22 days
changes in nausea
Time frame: 22 days
safety and tolerability
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
- Background: PubMed 1192373DeWys 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.
- Background: PubMed 11786587Jatoi 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.
- Background: PubMed 8035251Nelson 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.
- Derived from this study: PubMed 21343383Brisbois 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid H. de Kock, MD principal investigator
AHS Cancer Control Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Marinol (Dronabinol) in people with Cancer and Anorexia, run by Alberta Health services at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total caloric intake (time frame: 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316563, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2010.