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Supportive Care in Cancer

, Volume 26, Issue 9, pp 3029–3038 | Cite as

The effect of nabilone on appetite, nutritional status, and quality of life in lung cancer patients: a randomized, double-blind clinical trial

  • Jenny G. Turcott
  • María del Rocío Guillen Núñez
  • Diana Flores-Estrada
  • Luis F. Oñate-Ocaña
  • Zyanya Lucia Zatarain-Barrón
  • Feliciano Barrón
  • Oscar ArrietaEmail author
Original Article

Abstract

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.

Keywords

Anorexia Orexigenic agent Energy consumption Lung cancer Quality of life 

Notes

Funding

Nabilone and placebo were donated by vealent pharmaceutical without any further participation in the trial.

Compliance with ethical standards

Conflict of interest statement

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Supplementary material

520_2018_4154_MOESM1_ESM.docx (56 kb)
ESM 1 (DOCX 55 kb)

References

  1. 1.
    Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A (2015) Global cancer statistics, 2012. CA Cancer J Clin 65(2):87–108CrossRefPubMedGoogle Scholar
  2. 2.
    Arrieta O, Carmona A, Ramírez-Tirado LA, Flores-Estrada D, Macedo-Pérez EO, Martínez-Hernández JN, Corona-Cruz JF, Cardona AF, de la Garza J (2016) Survival of patients with advanced non-small cell lung cancer enrolled in clinical trials. Oncology 91:185–193CrossRefPubMedGoogle Scholar
  3. 3.
    Arrieta O et al (2013) National consensus of diagnosis and treatment of non-small cell lung cancer. Rev Invest Clin 65(Suppl 1):S5–S84Google Scholar
  4. 4.
    Miyauchi E, Inoue A, Usui K, Sugawara S, Maemondo M, Saito H, Fujita Y, Kato T, Suzuki T, Harada T, Watanabe H, Nakagawa T, Ichinose M (2017) Phase II study of modified carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer: North Japan lung cancer study group trial 1301. In: Oncologist, vol 22, pp 640–e59Google Scholar
  5. 5.
    Nasrah R et al (2016) Defining the role of dietary intake in determining weight change in patients with cancer cachexia. Clin NutrGoogle Scholar
  6. 6.
    Cardona AF, Rojas L, Wills B, Arrieta O, Carranza H, Vargas C, Otero J, Cuello M, Corrales L, Martín C, Ortiz C, Franco S, Rosell R, CLICaP (2016) Pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab in Hispanic patients with non-squamous non-small cell lung cancer: outcomes according to thymidylate synthase expression. PLoS One 11(5):e0154293CrossRefPubMedPubMedCentralGoogle Scholar
  7. 7.
    Ming-Hua C, Bao-Hua Z, Lei Y (2016) Mechanisms of anorexia cancer cachexia syndrome and potential benefits of traditional medicine and natural herbs. Curr Pharm Biotechnol 17(13):1147–1152CrossRefPubMedGoogle Scholar
  8. 8.
    Orozco-Morales M et al (2016) Interplay between cellular and molecular inflammatory mediators in lung Cancer. Mediat Inflamm 2016:3494608CrossRefGoogle Scholar
  9. 9.
    Arrieta O, de la Torre-Vallejo M, Lopez-Macias D, Orta D, Turcott J, Macedo-Perez EO, Sanchez-Lara K, Ramirez-Tirado LA, Baracos VE (2015) Nutritional status, body surface, and low lean body mass/body mass index are related to dose reduction and severe gastrointestinal toxicity induced by afatinib in patients with non-small cell lung cancer. Oncologist 20(8):967–974CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Jatoi A, Windschitl HE, Loprinzi CL, Sloan JA, Dakhil SR, Mailliard JA, Pundaleeka S, Kardinal CG, Fitch TR, Krook JE, Novotny PJ, Christensen B (2002) Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: a north central cancer treatment group study. J Clin Oncol 20(2):567–573CrossRefPubMedGoogle Scholar
  11. 11.
    Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC (2016) Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol 17(4):519–531CrossRefPubMedGoogle Scholar
  12. 12.
    Sanchez-Lara K et al (2014) Effects of an oral nutritional supplement containing eicosapentaenoic acid on nutritional and clinical outcomes in patients with advanced non-small cell lung cancer: randomised trial. Clin Nutr 33(6):1017–1023CrossRefPubMedGoogle Scholar
  13. 13.
    Brisbois TD, de Kock IH, Watanabe SM, Mirhosseini M, Lamoureux DC, Chasen M, MacDonald N, Baracos VE, Wismer WV (2011) Delta-9-tetrahydrocannabinol may palliate altered chemosensory perception in cancer patients: results of a randomized, double-blind, placebo-controlled pilot trial. Ann Oncol 22(9):2086–2093CrossRefPubMedGoogle Scholar
  14. 14.
    Wilson MM, Philpot C, Morley JE (2007) Anorexia of aging in long term care: is dronabinol an effective appetite stimulant?—a pilot study. J Nutr Health Aging 11(2):195–198PubMedGoogle Scholar
  15. 15.
    Maida V, Ennis M, Irani S, Corbo M, Dolzhykov M (2008) Adjunctive nabilone in cancer pain and symptom management: a prospective observational study using propensity scoring. J Support Oncol 6(3):119–124PubMedGoogle Scholar
  16. 16.
    Abrams DI (2016) Integrating cannabis into clinical cancer care. Curr Oncol 23(2):S8–S14PubMedPubMedCentralGoogle Scholar
  17. 17.
    Bedi G, Cooper ZD, Haney M (2013) Subjective, cognitive and cardiovascular dose-effect profile of nabilone and dronabinol in marijuana smokers. Addict Biol 18(5):872–881CrossRefPubMedGoogle Scholar
  18. 18.
    Turcott JG, Juárez-Hernández E, de la Torre-Vallejo M, Sánchez-Lara K, Luvian-Morales J, Arrieta O (2016) Value: changes in the detection and recognition thresholds of three basic tastes in lung cancer patients receiving cisplatin and paclitaxel and its association with nutritional and quality of life parameters. Nutr Cancer 68(2):241–249CrossRefPubMedGoogle Scholar
  19. 19.
    Cannabis In Cachexia Study, G et al (2006) Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: a multicenter, phase III, randomized, double-blind, placebo-controlled clinical trial from the cannabis-in-cachexia-study-group. J Clin Oncol 24(21):3394–3400CrossRefGoogle Scholar
  20. 20.
    Muscaritoli M, Anker SD, Argilés J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Fanelli FR, Schneider SM, Schols A, Sieber CC (2010) Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by special interest groups (SIG) “cachexia-anorexia in chronic wasting diseases” and “nutrition in geriatrics”. Clin Nutr 29(2):154–159CrossRefPubMedGoogle Scholar
  21. 21.
    Hernandez-Avila M et al (1998) Validity and reproducibility of a food frequency questionnaire to assess dietary intake of women living in Mexico City. Salud Publica Mex 40(2):133–140CrossRefPubMedGoogle Scholar
  22. 22.
    Yamanaka T, Matsumoto S, Teramukai S, Ishiwata R, Nagai Y, Fukushima M (2007) The baseline ratio of neutrophils to lymphocytes is associated with patient prognosis in advanced gastric cancer. Oncology 73(3–4):215–220CrossRefPubMedGoogle Scholar
  23. 23.
    Arrieta O, Núñez-Valencia C, Reynoso-Erazo L, Alvarado S, Flores-Estrada D, Angulo LP, Oñate-Ocaña LF (2012) Health-related quality of life in patients with lung cancer: validation of the Mexican-Spanish version and association with prognosis of the EORTC QLQ-LC13 questionnaire. Lung Cancer 77(1):205–211CrossRefPubMedGoogle Scholar
  24. 24.
    Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M (1994) The EORTC QLQ-LC13: a modular supplement to the EORTC Core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC study group on quality of life. Eur J Cancer 30A(5):635–642CrossRefPubMedGoogle Scholar
  25. 25.
    Sanchez-Lara K et al (2013) Brain activity correlated with food preferences: a functional study comparing advanced non-small cell lung cancer patients with and without anorexia. Nutrition 29(7–8):1013–1019CrossRefPubMedGoogle Scholar
  26. 26.
    Sanchez-Lara K et al (2012) Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer 64(4):526–534CrossRefPubMedGoogle Scholar
  27. 27.
    Arrieta O, Angulo LP, Núñez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martínez-López D, Alvarado S, Corona-Cruz JF, Oñate-Ocaña LF (2013) Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol 20(6):1941–1948CrossRefPubMedGoogle Scholar
  28. 28.
    Arrieta O, J L-M, Turcott JG, Oñate-Ocaña LF (2018) Quality of life and anorexia/cachexia in lung cancer: validation of the Spanish version of the FAACT instrumentGoogle Scholar
  29. 29.
    Turcott JG, Ramirez-Tirado LA, Oñate-Ocaña L., Flores-Estrada D., Zatarain-Barron Z., Soca-Chafre G., Arrieta O. (2017) FAACT-anorexia cachexia scale: cut-off value for the anorexia diagnosis in non-small cell lung cancer patientsGoogle Scholar
  30. 30.
    Cote M et al (2016) Improving quality of life with nabilone during radiotherapy treatments for head and neck cancers: a randomized double-blind placebo-controlled trial. Ann Otol Rhinol Laryngol 125(4):317–324CrossRefPubMedGoogle Scholar
  31. 31.
    Maida V (2006) The synthetic cannabinoid nabilone improves pain and symptom management in cancer patients., In SABCS: San Antonio. p. Abstract 3145Google Scholar
  32. 32.
    Arrieta O, Michel Ortega RM, Villanueva-Rodríguez G, Serna-Thomé MG, Flores-Estrada D, Diaz-Romero C, Rodríguez CM, Martínez L, Sánchez-Lara K (2010) Association of nutritional status and serum albumin levels with development of toxicity in patients with advanced non-small cell lung cancer treated with paclitaxel-cisplatin chemotherapy: a prospective study. BMC Cancer 10:50CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Jenny G. Turcott
    • 1
  • María del Rocío Guillen Núñez
    • 2
  • Diana Flores-Estrada
    • 1
  • Luis F. Oñate-Ocaña
    • 3
  • Zyanya Lucia Zatarain-Barrón
    • 1
  • Feliciano Barrón
    • 1
  • Oscar Arrieta
    • 1
    Email author
  1. 1.Head of Thoracic Oncology Unit and Experimental Oncology LaboratoryInstituto Nacional de Cancerología de México (INCan)MéxicoMexico
  2. 2.Pain Management Clinic, National Cancer Institute of Mexico (INCan)CDMXMexico
  3. 3.Clinical Research Division, Surgery Division, National Cancer Institute of Mexico (INCan)CDMXMexico

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