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Trial record 15 of 190 for:    Oral Cancer | ( Map: Mexico )

Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients

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ClinicalTrials.gov Identifier: NCT02802540
Recruitment Status : Unknown
Verified August 2016 by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Brief Summary:

Anorexia is common symptom in cancer patients and is associated with increased morbidity and mortality. However timely detection with objective tools is necessary to establish the diagnosis of anorexia and to assess the magnitude of change over time. The anorexia pathophysiology is not clearly understood and treatment options are limited. Anecdotal historical benefits of smoking marijuana on nausea, pain and anorexia led to studies with marijuana and synthetic cannabinoids from Δ-9-tetrahydrocannabinol, the main active agent in marijuana. The endogenous cannabinoid system with its receptors CB1 and CB2 regulate appetite in four functional levels: (1) limbic system (hedonistic quality), (2) hypothalamus (appetite stimulant), (3) intestinal, and (4) tissue adipose.

Nabilone, a synthetic analogue of THC approved in Mexico for nausea and vomiting induced by chemotherapy is also used in palliative care units for clinical improvement in increased appetite patients in terminal stages, however, there are no clinical trials demonstrating this benefit.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Anorexia Cachexia Weight Lose Drug: Nabilone Drug: Placebo Phase 2 Phase 3

Detailed Description:

Background: Lung cancer is the leading cause of cancer death in Mexico and the world. Malnutrition is often associated with this type of cancer appearing in about 40-50% of patients the diagnosis made, affecting the quality of life and prognosis, as well as increased toxicity to cancer treatment. Cancer anorexia is characterized by loss of appetite and is the main cause of reduced food consumption in lung cancer patients. Anorexia occurs in up to 25% of cases. Unfortunately, current therapies available to treat anorexia and / or cachexia associated with cancer provide only partial results, mainly because the intervention is delayed and the development of an early and effective intervention is still looking.

In most patients, malnutrition is associated with a hyporexia secondary to the production of pro-inflammatory cytokines such as tumor necrosis factor (TNF), leading to an increase in metabolism and appetite loss. Nabilone is a synthetic cannabinoid derivative that is widely used in oncology for its antiemetic and adjuvant effect of pain. Although widely used for the treatment of anorexia in palliative care, no randomized clinical trials demonstrating an effect on cancer-associated anorexia, however, in animal models, stimulation of cannabinoid receptors, mainly through CB1 receptor can modulate hypothalamic circuits in the brain stem, which in turn regulate food intake and satiety. Moreover cannabinoids are able to block the effects of TNF in the nervous system, which is associated with appetite changes in cancer patients. Additionally, agonists of cannabinoid receptors attenuated weight loss in murine models of anorexia.

Additionally, to diagnosis anorexia The Anorexia-Cachexia scale (A/CS-12) from The Functional Assessment of Anorexia-Cachexia therapy (FAACT) questionnaire relates differences in symptoms and severity, assigning a value of 0-4 for each of 12 items. A 2010 consensus of special interest group of CACS from ESPEN (The European Society for Clinical Nutrition and Metabolism) in order to unify criteria, proposed that a score ≤24 of the A/CS-12 would be enough to establish a diagnosis of anorexia.

The administration of Nabilone in patients with anorexia associated with Non-Small Cell Lung Cancer (NSCLC) is expected to increase appetite, nutritional status and quality of life.

Methods: randomized double-blind clinical trial assessing Nabilone effect in non-small cell lung cancer (NSCLC) patients with unresectable stage III/IV NSCLC, ECOG performance status (ECOG PS) 1-2 and anorexia (main criteria: score of Anorexia Cachexia scale (AC/S-12) from Functional Assessment of Anorexia Cachexia Therapy ≤24). Patients are randomized to Nabilone at 0.5mg to 1mg, or placebo, given daily orally for 8 weeks. Changes are evaluated from baseline to week 2, 4, and 8.

Time Assessment Dose T0 Baseline 0.5mg T1 2 weeks 1 mg T2 4 weeks 1 mg T3 8 weeks 1 mg

Sample size:

To determine the sample size is considered the effect of cannabinoid (dronabinol, 2.5 mg / 22 days) in appetite in cancer patients by a difference in proportions of 34% more than placebo, requiring 32 patients per group plus 20% of loss gives us a total of 39 patients per group, with a power of 90% and an α of 0.05


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Patients With Anorexia Associated With Advanced Lung Cancer: Randomized Double Blind Clinical Trial
Study Start Date : December 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nabilone

Arm Intervention/treatment
Experimental: Nabilone
Patients start receiving a dose of 0.5 mg daily oral nabilone the first 2 weeks and then 1 mg to complete 8 weeks.
Drug: Nabilone
Patients going to take 0.5 mg capsules of nabilone (CESAMET) the first 2 weeks and then increased to 1 mg to complete 8 weeks.
Other Name: cesamet

Placebo Comparator: placebo
Patients start receiving a dose of 0.5 mg daily oral placebo the first 2 weeks and then 1 mg to complete 8 weeks.
Drug: Placebo
Patients going to take capsules of placebo until complete 8 weeks.
Other Name: placebo nabilona




Primary Outcome Measures :
  1. anorexia [ Time Frame: from the start of consumption until 8 weeks. ]
    Lack of desire to eat food. Will be obtained through a questionnaire Anorexia / Cachexia scale from Functional Assessment of Anorexia Cachexia Therapy (FAACT) (score ≤24 diagnosis of anorexia)

  2. percentage weight loss [ Time Frame: from the start of consumption until 8 weeks. ]
    percentage weight loss in the last month

  3. Body Mass Index [ Time Frame: from the start of consumption until 8 weeks. ]
    It is an index of a person's weight in relation to height

  4. Subjective Global Assessment [ Time Frame: from the start of consumption until 8 weeks. ]
    convenient, fast and cheaper method used to make a nutritional assessment, consisting of 3 parts: anamnesis, physical examination and qualification.

  5. energy consumption [ Time Frame: from the start of consumption until 8 weeks. ]
    Total calories consumed on average per day for a subject


Secondary Outcome Measures :
  1. protein consumption [ Time Frame: from the start of consumption until 8 weeks. ]
    Total protein grams consumed on average per day for a subject

  2. lipids consumption [ Time Frame: from the start of consumption until 8 weeks. ]
    Total lipids grams consumed on average per day for a subject

  3. carbohydrate consumption [ Time Frame: from the start of consumption until 8 weeks. ]
    Total carbohydrate grams consumed on average per day for a subject

  4. nausea [ Time Frame: from the start of consumption until 8 weeks. ]
    adverse effect from Common terminology criteria for adverse event

  5. vomiting [ Time Frame: from the start of consumption until 8 weeks. ]
    adverse effect from Common terminology criteria for adverse event

  6. constipation [ Time Frame: from the start of consumption until 8 weeks. ]
    adverse effect from Common terminology criteria for adverse event

  7. Diarrhea [ Time Frame: from the start of consumption until 8 weeks. ]
    adverse effect from Common terminology criteria for adverse event

  8. Dysgeusia [ Time Frame: from the start of consumption until 8 weeks. ]
    adverse effect from Common terminology criteria for adverse event

  9. Global Status of Quality of Life [ Time Frame: from the start of consumption until 8 weeks. ]
    The Global status of Quality of Life evaluation is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer with the items 29 and 30.

  10. Physical functioning [ Time Frame: from the start of consumption until 8 weeks. ]
    The Physical functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

  11. Role Functioning [ Time Frame: from the start of consumption until 8 weeks. ]
    The Role functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

  12. Emotional Functioning [ Time Frame: from the start of consumption until 8 weeks. ]
    The Emotional Functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

  13. Social Functioning [ Time Frame: from the start of consumption until 8 weeks. ]
    The Social Functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

  14. Nausea/Vomiting [ Time Frame: from the start of consumption until 8 weeks. ]
    The Nausea/Vomiting evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

  15. Fatigue [ Time Frame: from the start of consumption until 8 weeks. ]
    The Fatigue evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer

  16. appetite loss [ Time Frame: from the start of consumption until 8 weeks. ]
    The appetite loss evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-small cell lung cancer (NSCLC) patients with unresectable stage IIIB/IV
  • ECOG performance status ≤2
  • Life expectancy of > 4 months at time of screening
  • If woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)
  • Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures

Exclusion Criteria:

  • Known allergy to some derivative of marijuana, there is a dependency or who have previously been treated with cannabinoids.
  • Consumption of dietary supplements at baseline.
  • Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and Anamorelin.

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): NCT02802540


Contacts
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Contact: Oscar Arrieta, MD M Sc 015556280400 ext 71100 ogarrieta@gmail.com
Contact: Diana Flores 015556280400 ext 71101 clinicacancerpulmonincan@gmail.com

Locations
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Mexico
Instituto Nacional de Cancerologia Recruiting
Mexico City, Mexico, 14080
Contact: Oscar Arrieta    015556280400    ogarrieta@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
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Principal Investigator: Oscar Arrieta, MD M Sc Instituto Nacional de Cancerología

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, MD M Sc, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT02802540     History of Changes
Other Study ID Numbers: NABILONA
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publishing the results

Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:
nabilone
anorexia
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Anorexia
Cachexia
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Nabilone
Dronabinol
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hallucinogens