Study register · detailRCT (placebo-kontrolliert) · Appetite Stimulation · 2018
The effect of nabilone on appetite, nutritional status, and quality of life in lung cancer patients: a randomized, double-blind clinical trial
Turcott et al.·Supportive Care in CancerImpact 1.7
Clear benefitGRADEModerate116 citations
Samplen = 47 Pat.
Duration8 weeks
ControlPlacebo
EndpointAppetite / caloric intake
Blindingdoppelblind
DesignRCT (placebo-kontrolliert)
Cannabinoidthc
Max. dose1.0 mg
Routeoral
”Key finding
After 8 weeks, nabilone led to significantly increased caloric intake (+342 kcal) and carbohydrate intake (+64 g) as well as improvements in several quality-of-life dimensions (role function, emotional function, social function, insomnia) compared to placebo.
Summary
n=47 patients with advanced NSCLC and anorexia, randomized to nabilone (0,5 mg/2 weeks, then 1,0 mg/6 weeks) vs. placebo over 8 weeks. Nabilone group increased caloric intake by 342 kcal and carbohydrate intake by 64 g (p=0,040). Significant QoL improvements in role function (p=0,030), emotional function (p=0,018), social function (p=0,036), pain (p=0,06) and insomnia (p=0,020).
P
PopulationAdults with advanced non-small cell lung cancer (NSCLC) and anorexia, n=47
I
InterventionNabilone oral 0,5 mg/2 weeks, then 1,0 mg/6 weeks
C
ControlPlacebo
O
OutcomeSignificantly higher carbohydrate intake (+64 g, p=0,040) and caloric intake (+342 kcal) in the nabilone group; improvements in quality of life in role function (p=0,030), emotional function (p=0,018), social function (p=0,036), pain (p=0,06) and insomnia (p=0,020)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeClear benefit
Citations / year★★★★★
Authors
Turcott J G, del Rocío Guillen Núñez M, Flores-Estrada D et al.
Background: Over one half of the patients diagnosed with advanced lung cancer experience anorexia. In addition to its high incidence, cancer-induced anorexia promotes the development of the anorexia-cachexia syndrome, which is related to poor clinical outcomes. Recently, drugs derived from cannabinoids, such as Nabilone, have been recognized for their appetite improvement properties; however, clinical trials to support their use in cancer patients are necessary.
Methods: This is a randomized, double-blind, placebo-controlled clinical trial to assess the effect of Nabilone vs. placebo on the appetite, nutritional status, and quality of life in patients diagnosed with advanced Non-small cell lung cancer (NSCLC) (NCT02802540).
Results: A total of 65 patients from the outpatient clinic at the National Institute of Cancer (INCan) were assessed for eligibility and 47 were randomized to receive Nabilone (0.5 mg/2 weeks followed by 1.0 mg/6 weeks) or placebo. After 8 weeks of treatment, patients who received Nabilone increased their caloric intake (342-kcal) and had a significantly higher intake of carbohydrates (64 g) compared to patients receiving placebo (p = 0.040). Quality of life also showed significant improvements in patients in the experimental arm of the trial, particularly in role functioning (p = 0.030), emotional functioning (p = 0.018), social functioning (p = 0.036), pain (p = 0.06), and insomnia (p = 0.020). No significant change in these scales was seen in the control group.
Conclusion: Nabilone is an adequate and safe therapeutic option to aid in the treatment of patients diagnosed with anorexia. Larger trials are necessary in order to draw robust conclusions in regard to its efficacy in lung cancer patients.