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
Klarer NutzenGRADEModerat116 Zitate
Stichproben = 47 Pat.
Dauer8 Wochen
KontrollePlacebo
EndpunktAppetit / Kalorienaufnahme
Verblindungdoppelblind
DesignRCT (placebo-kontrolliert)
Cannabinoidthc
Max. Dosis1.0 mg
Applikationoral
”Kernaussage
Nabilone führte nach 8 Wochen zu signifikant erhöhter Kalorienaufnahme (+342 kcal) und Kohlenhydrataufnahme (+64 g) sowie Verbesserungen in mehreren Lebensqualitäts-Dimensionen (Rollenfunktion, emotionale Funktion, soziale Funktion, Schlaflosigkeit) im Vergleich zu Placebo.
Zusammenfassung
n=47 Patienten mit fortgeschrittenem NSCLC und Anorexie, randomisiert zu Nabilon (0,5 mg/2 Wochen, dann 1,0 mg/6 Wochen) vs. Placebo über 8 Wochen. Nabilon-Gruppe steigerte Kalorienaufnahme um 342 kcal und Kohlenhydrat-Intake um 64 g (p=0,040). Signifikante QoL-Verbesserungen in Rollenfunktion (p=0,030), emotionaler Funktion (p=0,018), sozialer Funktion (p=0,036), Schmerz (p=0,06) und Schlaflosigkeit (p=0,020).
P
PopulationErwachsene mit fortgeschrittenem nicht-kleinzelligem Lungenkrebs (NSCLC) und Anorexie, n=47
I
InterventionNabilone oral 0,5 mg/2 Wochen, danach 1,0 mg/6 Wochen
C
KontrollePlacebo
O
OutcomeSignifikant höhere Kohlenhydratzufuhr (+64 g, p=0,040) und Kalorienaufnahme (+342 kcal) in der Nabilone-Gruppe; Verbesserungen der Lebensqualität in Rollenfunktion (p=0,030), emotionaler Funktion (p=0,018), sozialer Funktion (p=0,036), Schmerz (p=0,06) und Insomnie (p=0,020)
Vertrauen in die Evidenz
Sehr niedrigNiedrigModeratHoch
Moderat
Dritte von vier GRADE-Stufen, die Effektschätzung ist wahrscheinlich verlässlich.
Herabgestuft wegen
Ungenauigkeit
Qualitätsprofil
Größe★★★★★
VerblindungDoppelblind
EffektstärkeKlarer Nutzen
Zitate / Jahr★★★★★
Autoren
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.