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The Effect of Cannabis in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03245658
Recruitment Status : Unknown
Verified August 2017 by Jens Rikardt Andersen, University of Copenhagen.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Collaborators:
Augustinus Fonden
Københavns Universitet
Familien Hede Nielsens Fond
Information provided by (Responsible Party):
Jens Rikardt Andersen, University of Copenhagen

Brief Summary:

The prevalence of malnutrition is overwhelming in pancreatic cancer patients, >80% experience a weight loss >10% of their habitual weight, which may develop into cancer cachexia. Cachexia may cause decreased quality of life, increased mortality and morbidity e.g. poorer response to antitumor treatment, longer length of stay, higher complications rate and shorter life expectancy. There is currently no effective treatment of cancer cachexia, but clinical research in medical cannabis show promising results. The cannabinoids THC and CBD show the highest pharmacological effect, but cannabis consists of >70 cannabinoids. THC and CBD exert their effect on the endocannabinoid system which modulate physiological systems such as pain, inflammation, appetite and energy balance. Thus, this potential orexigenic effect from THC and CBD may improve the nutritional state in patients with pancreatic cancer. Taking the above scientific rationale and the lack of evidence into account, the relevance of this clinical trial appears high.

This clinical trial is an eight-week crossover design examining the effects of the cannabinoids THC and CBD on energy- and protein intake and lean body mass as a measure of appetite, nausea and quality of life. A characterization of the metabolism is analysed through a metabolomics analysis.


Condition or disease Intervention/treatment Phase
Neoplasms Pancreatic Cachexia; Cancer Cannabis Appetite Loss Palliative Medicine Morbidity Mortality Drug: THC and CBD Mixture Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Medical Cannabis Inpatients With Palliative Pancreatic Cancer
Estimated Study Start Date : October 6, 2017
Estimated Primary Completion Date : May 6, 2018
Estimated Study Completion Date : October 6, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: THC and CBD Mixture
32 patients with palliative pancreatic cancer, intervention with oral drops of THC, 25mg/ml and CBD 50mg/ml, daily administered for 4 weeks
Drug: THC and CBD Mixture
Individually titrated doses on daily basis
Other Name: Medical cannabis oral drops

No Intervention: Control
32 patients with palliative pancreatic cancer, no experimental treatment,



Primary Outcome Measures :
  1. Energy and protein intake [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    Dietary history (% of estimated needs - NRS 2002)


Secondary Outcome Measures :
  1. Lean body mass [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    Bioimpedance (% of body weight, kg)

  2. Appetite 1 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    VAS (cm on 10 cm scale)

  3. Appetite 2 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    Dietary history (VAS (cm on 10 cm scale))

  4. Appetite 3 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    EORTC QLQ-C30 (score, standard for the Quality of Life entity)

  5. Appetite 4 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)

  6. Quality of life 1 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    EORTC QLQ-C30 (score, standard for the Quality of Life entity)

  7. Quality of life 2 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)

  8. Quality of life 3 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    VAS (VAS (cm on 10 cm scale))

  9. Pain 1 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    EORTC QLQ-C30 (score, standard for the Quality of Life entity)

  10. Pain 2 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)

  11. Pain 3 [ Time Frame: The outcome measure will be assessed at day 0 and at week 4 ]
    VAS (VAS (cm on 10 cm scale))

  12. Mortality (8 weeks) [ Time Frame: 8 weeks ]
    Patient records, national register



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult, palliative pancreatic cancer diagnosis, weight loss > 5%, understand and read Danish.

Exclusion Criteria:

  • Regular use of cannabis, psychiatric disorders, alcohol abuse, life expectancy < 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245658


Contacts
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Contact: Jens Rikardt Andersen, MD, MPA 004523346654 jra@nexs.ku.dk
Contact: Rikke Lundsgaard Nielsen, Msc stud 004540461306 gdz384@alumni.ku.dk

Locations
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Denmark
Department of clinical oncology, Næstved-Roskilde Hospital Not yet recruiting
Naestved, Denmark, 4700
Contact: Jens Rikardt Andersen, MD, MPA    004523346654    jra@nexs.ku.dk   
Contact: Rikke Lundsgaard Nielsen, Msc stud    004540461306    gdz384@alumni.ku.dk   
Principal Investigator: Jens Rikardt Andersen, MD         
Sponsors and Collaborators
Jens Rikardt Andersen
Augustinus Fonden
Københavns Universitet
Familien Hede Nielsens Fond
Investigators
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Principal Investigator: Jens Rikardt Andersen, MD, MPA University of Copenhagen

Publications of Results:

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Responsible Party: Jens Rikardt Andersen, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03245658     History of Changes
Other Study ID Numbers: H-17000277
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cachexia
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Nabiximols
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs