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

NCT02802540 | Unknown Phase 2 DMC

• 1 other identifier: NABILONA
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer; Anorexia; Cachexia; Weight Lose

Keywords

nabilone; anorexia; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (5)

• anorexia

  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)

  from the start of consumption until 8 weeks.

• percentage weight loss

  percentage weight loss in the last month

  from the start of consumption until 8 weeks.

• Body Mass Index

  It is an index of a person's weight in relation to height

  from the start of consumption until 8 weeks.

• Subjective Global Assessment

  convenient, fast and cheaper method used to make a nutritional assessment, consisting of 3 parts: anamnesis, physical examination and qualification.

  from the start of consumption until 8 weeks.

• energy consumption

  Total calories consumed on average per day for a subject

  from the start of consumption until 8 weeks.

Secondary Outcomes (16)

• protein consumption

  from the start of consumption until 8 weeks.

• lipids consumption

  from the start of consumption until 8 weeks.

• carbohydrate consumption

  from the start of consumption until 8 weeks.

• nausea

  from the start of consumption until 8 weeks.

• vomiting

  from the start of consumption until 8 weeks.

Study Arms (2)

Nabilone

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Nabilone DRUG

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.

Also known as: cesamet

Nabilone

Placebo DRUG

Patients going to take capsules of placebo until complete 8 weeks.

Also known as: placebo nabilona

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

RECRUITING

Related Publications (50)

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

  PMID: 25220842 BACKGROUND

• Samet JM. Environmental causes of lung cancer: what do we know in 2003? Chest. 2004 May;125(5 Suppl):80S-3S. doi: 10.1378/chest.125.5_suppl.80s.

  PMID: 15136426 BACKGROUND

• Arrieta O, Campos-Parra AD, Zuloaga C, Aviles A, Sanchez-Reyes R, Manriquez ME, Covian-Molina E, Martinez-Barrera L, Meneses A, Cardona A, Borbolla-Escoboza JR. Clinical and pathological characteristics, outcome and mutational profiles regarding non-small-cell lung cancer related to wood-smoke exposure. J Thorac Oncol. 2012 Aug;7(8):1228-34. doi: 10.1097/JTO.0b013e3182582a93.

  PMID: 22659961 BACKGROUND

• Watanabe H, Yamamoto N, Tamura T, Shimoyama T, Hotta K, Inoue A, Sawada M, Akiyama Y, Kusaba H, Nokihara H, Sekine I, Kunitoh H, Ohe Y, Kodama T, Saijo N. Study of paclitaxel and dose escalation of cisplatin in patients with advanced non-small cell lung cancer. Jpn J Clin Oncol. 2003 Dec;33(12):626-30. doi: 10.1093/jjco/hyg116.

  PMID: 14769840 BACKGROUND

• Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.

  PMID: 14691125 BACKGROUND

• Sarhill N, Mahmoud FA, Christie R, Tahir A. Assessment of nutritional status and fluid deficits in advanced cancer. Am J Hosp Palliat Care. 2003 Nov-Dec;20(6):465-73. doi: 10.1177/104990910302000610.

  PMID: 14649565 BACKGROUND

• Arrieta O, Michel Ortega RM, Villanueva-Rodriguez G, Serna-Thome MG, Flores-Estrada D, Diaz-Romero C, Rodriguez CM, Martinez L, Sanchez-Lara K. 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. 2010 Feb 21;10:50. doi: 10.1186/1471-2407-10-50.

  PMID: 20170547 BACKGROUND

• Sanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. 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. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10.

  PMID: 22489794 BACKGROUND

• Bossola M, Pacelli F, Doglietto GB. Novel treatments for cancer cachexia. Expert Opin Investig Drugs. 2007 Aug;16(8):1241-53. doi: 10.1517/13543784.16.8.1241.

  PMID: 17685872 BACKGROUND

• Wie GA, Cho YA, Kim SY, Kim SM, Bae JM, Joung H. Prevalence and risk factors of malnutrition among cancer patients according to tumor location and stage in the National Cancer Center in Korea. Nutrition. 2010 Mar;26(3):263-8. doi: 10.1016/j.nut.2009.04.013. Epub 2009 Aug 8.

  PMID: 19665873 BACKGROUND

• Ross PJ, Ashley S, Norton A, Priest K, Waters JS, Eisen T, Smith IE, O'Brien ME. Do patients with weight loss have a worse outcome when undergoing chemotherapy for lung cancers? Br J Cancer. 2004 May 17;90(10):1905-11. doi: 10.1038/sj.bjc.6601781.

  PMID: 15138470 BACKGROUND

• Slaviero KA, Read JA, Clarke SJ, Rivory LP. Baseline nutritional assessment in advanced cancer patients receiving palliative chemotherapy. Nutr Cancer. 2003;46(2):148-57. doi: 10.1207/S15327914NC4602_07.

  PMID: 14690790 BACKGROUND

• Muscaritoli M, Anker SD, Argiles J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Rossi Fanelli F, Schneider SM, Schols A, Sieber CC. 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. 2010 Apr;29(2):154-9. doi: 10.1016/j.clnu.2009.12.004. Epub 2010 Jan 8.

  PMID: 20060626 BACKGROUND

• Marin Caro MM, Laviano A, Pichard C. Impact of nutrition on quality of life during cancer. Curr Opin Clin Nutr Metab Care. 2007 Jul;10(4):480-7. doi: 10.1097/MCO.0b013e3281e2c983.

  PMID: 17563467 BACKGROUND

• Kosacka M, Werynska B, Golecki M, Jankowska R, Passowicz-Muszynska E. [The incidence and pathogenesis of cancer anorexia-cachexia syndrome in lung cancer]. Pneumonol Alergol Pol. 2008;76(5):360-5. Polish.

  PMID: 19003767 BACKGROUND

• Fortunati N, Manti R, Birocco N, Pugliese M, Brignardello E, Ciuffreda L, Catalano MG, Aragno M, Boccuzzi G. Pro-inflammatory cytokines and oxidative stress/antioxidant parameters characterize the bio-humoral profile of early cachexia in lung cancer patients. Oncol Rep. 2007 Dec;18(6):1521-7.

  PMID: 17982639 BACKGROUND

• Jatoi A, Qi Y, Kendall G, Jiang R, McNallan S, Cunningham J, Mandrekar S, Yang P. The cancer anorexia/weight loss syndrome: exploring associations with single nucleotide polymorphisms (SNPs) of inflammatory cytokines in patients with non-small cell lung cancer. Support Care Cancer. 2010 Oct;18(10):1299-304. doi: 10.1007/s00520-009-0748-6. Epub 2009 Dec 15.

  PMID: 20012999 BACKGROUND

• Laviano A, Meguid MM, Inui A, Muscaritoli M, Rossi-Fanelli F. Therapy insight: Cancer anorexia-cachexia syndrome--when all you can eat is yourself. Nat Clin Pract Oncol. 2005 Mar;2(3):158-65. doi: 10.1038/ncponc0112.

  PMID: 16264909 BACKGROUND

• Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.

  PMID: 7424938 BACKGROUND

• Laviano A, Koverech A, Mari A. Cachexia: clinical features when inflammation drives malnutrition. Proc Nutr Soc. 2015 Nov;74(4):348-54. doi: 10.1017/S0029665115000117. Epub 2015 Mar 26.

  PMID: 25809872 BACKGROUND

• Argiles JM, Busquets S, Lopez-Soriano FJ. The pivotal role of cytokines in muscle wasting during cancer. Int J Biochem Cell Biol. 2005 Oct;37(10):2036-46. doi: 10.1016/j.biocel.2005.03.014.

  PMID: 16105746 BACKGROUND

• Deans C, Wigmore SJ. Systemic inflammation, cachexia and prognosis in patients with cancer. Curr Opin Clin Nutr Metab Care. 2005 May;8(3):265-9. doi: 10.1097/01.mco.0000165004.93707.88.

  PMID: 15809528 BACKGROUND

• LeBlanc TW, Samsa GP, Wolf SP, Locke SC, Cella DF, Abernethy AP. Validation and real-world assessment of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT) scale in patients with advanced non-small cell lung cancer and the cancer anorexia-cachexia syndrome (CACS). Support Care Cancer. 2015 Aug;23(8):2341-7. doi: 10.1007/s00520-015-2606-z. Epub 2015 Jan 14.

  PMID: 25586527 BACKGROUND

• Gupta D, Lammersfeld CA, Vashi PG, King J, Dahlk SL, Grutsch JF, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer. BMC Cancer. 2009 Jan 28;9:37. doi: 10.1186/1471-2407-9-37.

  PMID: 19175932 BACKGROUND

• Kubrak C, Jensen L. Critical evaluation of nutrition screening tools recommended for oncology patients. Cancer Nurs. 2007 Sep-Oct;30(5):E1-6. doi: 10.1097/01.NCC.0000290818.45066.00.

  PMID: 17876173 BACKGROUND

• Hernandez-Avila M, Romieu I, Parra S, Hernandez-Avila J, Madrigal H, Willett W. Validity and reproducibility of a food frequency questionnaire to assess dietary intake of women living in Mexico City. Salud Publica Mex. 1998 Mar-Apr;40(2):133-40. doi: 10.1590/s0036-36341998000200005.

  PMID: 9617194 BACKGROUND

• Thoresen L, Fjeldstad I, Krogstad K, Kaasa S, Falkmer UG. Nutritional status of patients with advanced cancer: the value of using the subjective global assessment of nutritional status as a screening tool. Palliat Med. 2002 Jan;16(1):33-42. doi: 10.1191/0269216302pm486oa.

  PMID: 11963449 BACKGROUND

• Berry EM, Mechoulam R. Tetrahydrocannabinol and endocannabinoids in feeding and appetite. Pharmacol Ther. 2002 Aug;95(2):185-90. doi: 10.1016/s0163-7258(02)00257-7.

  PMID: 12182965 BACKGROUND

• Touw M. The religious and medicinal uses of Cannabis in China, India and Tibet. J Psychoactive Drugs. 1981 Jan-Mar;13(1):23-34. doi: 10.1080/02791072.1981.10471447. No abstract available.

  PMID: 7024492 BACKGROUND

• Davis MP. Oral nabilone capsules in the treatment of chemotherapy-induced nausea and vomiting and pain. Expert Opin Investig Drugs. 2008 Jan;17(1):85-95. doi: 10.1517/13543784.17.1.85.

  PMID: 18095921 BACKGROUND

• Osei-Hyiaman D. Endocannabinoid system in cancer cachexia. Curr Opin Clin Nutr Metab Care. 2007 Jul;10(4):443-8. doi: 10.1097/MCO.0b013e3281900ecc.

  PMID: 17563462 BACKGROUND

• Pisanti S, Malfitano AM, Grimaldi C, Santoro A, Gazzerro P, Laezza C, Bifulco M. Use of cannabinoid receptor agonists in cancer therapy as palliative and curative agents. Best Pract Res Clin Endocrinol Metab. 2009 Feb;23(1):117-31. doi: 10.1016/j.beem.2009.02.001.

  PMID: 19285265 BACKGROUND

• Di Marzo V, Goparaju SK, Wang L, Liu J, Batkai S, Jarai Z, Fezza F, Miura GI, Palmiter RD, Sugiura T, Kunos G. Leptin-regulated endocannabinoids are involved in maintaining food intake. Nature. 2001 Apr 12;410(6830):822-5. doi: 10.1038/35071088.

  PMID: 11298451 BACKGROUND

• Walsh D, Nelson KA, Mahmoud FA. Established and potential therapeutic applications of cannabinoids in oncology. Support Care Cancer. 2003 Mar;11(3):137-43. doi: 10.1007/s00520-002-0387-7. Epub 2002 Aug 21.

  PMID: 12618922 BACKGROUND

• Kramer JL. Medical marijuana for cancer. CA Cancer J Clin. 2015 Mar;65(2):109-22. doi: 10.3322/caac.21260. Epub 2014 Dec 10.

  PMID: 25503438 BACKGROUND

• Cannabis-In-Cachexia-Study-Group; Strasser F, Luftner D, Possinger K, Ernst G, Ruhstaller T, Meissner W, Ko YD, Schnelle M, Reif M, Cerny T. 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. 2006 Jul 20;24(21):3394-400. doi: 10.1200/JCO.2005.05.1847.

  PMID: 16849753 RESULT

• Foltin RW, Brady JV, Fischman MW. Behavioral analysis of marijuana effects on food intake in humans. Pharmacol Biochem Behav. 1986 Sep;25(3):577-82. doi: 10.1016/0091-3057(86)90144-9.

  PMID: 3774823 RESULT

• Plasse TF, Gorter RW, Krasnow SH, Lane M, Shepard KV, Wadleigh RG. Recent clinical experience with dronabinol. Pharmacol Biochem Behav. 1991 Nov;40(3):695-700. doi: 10.1016/0091-3057(91)90385-f.

  PMID: 1666930 RESULT

• Nelson K, Walsh D, Deeter P, Sheehan F. A phase II study of delta-9-tetrahydrocannabinol for appetite stimulation in cancer-associated anorexia. J Palliat Care. 1994 Spring;10(1):14-8.

  PMID: 8035251 RESULT

• Hart CL, Ward AS, Haney M, Comer SD, Foltin RW, Fischman MW. Comparison of smoked marijuana and oral Delta(9)-tetrahydrocannabinol in humans. Psychopharmacology (Berl). 2002 Dec;164(4):407-15. doi: 10.1007/s00213-002-1231-y. Epub 2002 Sep 14.

  PMID: 12457271 RESULT

• Jatoi A, Windschitl HE, Loprinzi CL, Sloan JA, Dakhil SR, Mailliard JA, Pundaleeka S, Kardinal CG, Fitch TR, Krook JE, Novotny PJ, Christensen B. Dronabinol versus megestrol acetate versus combination therapy for cancer-associated anorexia: a North Central Cancer Treatment Group study. J Clin Oncol. 2002 Jan 15;20(2):567-73. doi: 10.1200/JCO.2002.20.2.567.

  PMID: 11786587 RESULT

• Woolridge E, Barton S, Samuel J, Osorio J, Dougherty A, Holdcroft A. Cannabis use in HIV for pain and other medical symptoms. J Pain Symptom Manage. 2005 Apr;29(4):358-67. doi: 10.1016/j.jpainsymman.2004.07.011.

  PMID: 15857739 RESULT

• Haney M, Rabkin J, Gunderson E, Foltin RW. Dronabinol and marijuana in HIV(+) marijuana smokers: acute effects on caloric intake and mood. Psychopharmacology (Berl). 2005 Aug;181(1):170-8. doi: 10.1007/s00213-005-2242-2. Epub 2005 Oct 15.

  PMID: 15778874 RESULT

• Walsh D, Kirkova J, Davis MP. The efficacy and tolerability of long-term use of dronabinol in cancer-related anorexia: a case series. J Pain Symptom Manage. 2005 Dec;30(6):493-5. doi: 10.1016/j.jpainsymman.2005.11.007. No abstract available.

  PMID: 16376734 RESULT

• Zutt M, Hanssle H, Emmert S, Neumann C, Kretschmer L. [Dronabinol for supportive therapy in patients with malignant melanoma and liver metastases]. Hautarzt. 2006 May;57(5):423-7. doi: 10.1007/s00105-005-1063-x. German.

  PMID: 16408219 RESULT

• Haney M, Gunderson EW, Rabkin J, Hart CL, Vosburg SK, Comer SD, Foltin RW. Dronabinol and marijuana in HIV-positive marijuana smokers. Caloric intake, mood, and sleep. J Acquir Immune Defic Syndr. 2007 Aug 15;45(5):545-54. doi: 10.1097/QAI.0b013e31811ed205.

  PMID: 17589370 RESULT

• Maida V, Ennis M, Irani S, Corbo M, Dolzhykov M. Adjunctive nabilone in cancer pain and symptom management: a prospective observational study using propensity scoring. J Support Oncol. 2008 Mar;6(3):119-24.

  PMID: 18402303 RESULT

• Brisbois TD, de Kock IH, Watanabe SM, Mirhosseini M, Lamoureux DC, Chasen M, MacDonald N, Baracos VE, Wismer WV. Delta-9-tetrahydrocannabinol may palliate altered chemosensory perception in cancer patients: results of a randomized, double-blind, placebo-controlled pilot trial. Ann Oncol. 2011 Sep;22(9):2086-2093. doi: 10.1093/annonc/mdq727. Epub 2011 Feb 22.

  PMID: 21343383 RESULT

• Rowland KM Jr, Loprinzi CL, Shaw EG, Maksymiuk AW, Kuross SA, Jung SH, Kugler JW, Tschetter LK, Ghosh C, Schaefer PL, Owen D, Washburn JH Jr, Webb TA, Mailliard JA, Jett JR. Randomized double-blind placebo-controlled trial of cisplatin and etoposide plus megestrol acetate/placebo in extensive-stage small-cell lung cancer: a North Central Cancer Treatment Group study. J Clin Oncol. 1996 Jan;14(1):135-41. doi: 10.1200/JCO.1996.14.1.135.

  PMID: 8558188 RESULT

• Turcott JG, Del Rocio Guillen Nunez M, Flores-Estrada D, Onate-Ocana LF, Zatarain-Barron ZL, Barron F, Arrieta O. The effect of nabilone on appetite, nutritional status, and quality of life in lung cancer patients: a randomized, double-blind clinical trial. Support Care Cancer. 2018 Sep;26(9):3029-3038. doi: 10.1007/s00520-018-4154-9. Epub 2018 Mar 17.

  PMID: 29550881 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Anorexia; Cachexia

Interventions

nabilone

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness

Study Officials

• Oscar Arrieta, MD M Sc

  Instituto Nacional de Cancerologia de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Arrieta, MD M Sc

CONTACT

015556280400; ogarrieta@gmail.com

Diana Flores

CONTACT

015556280400; clinicacancerpulmonincan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD M Sc

Study Record Dates

• First Submitted: May 22, 2016
• First Posted: June 16, 2016
• Study Start: December 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 31, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)