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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; 24(21):3394-400JC

Abstract

PURPOSE

To compare the effects of cannabis extract (CE), delta-9-tetrahydrocannabinol (THC), and placebo (PL) on appetite and quality of life (QOL) in patients with cancer-related anorexia-cachexia syndrome (CACS).

PATIENTS AND METHODS

Adult patients with advanced cancer, CACS, weight loss (> or = 5% over 6 months), and Eastern Cooperative Oncology Group (ECOG) performance status (PS) < or = 2 were randomly assigned (2:2:1) to receive CE (standardized for 2.5 mg THC and 1 mg cannabidiol) or THC (2.5 mg) or PL orally, twice daily for 6 weeks. Appetite, mood, and nausea were monitored daily with a visual analog scale (VAS); QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (composite score: questions 29 and 30). Cannabinoid-related toxicity was assessed every 2 weeks.

RESULTS

Of 289 patients screened, 243 were randomly assigned and 164 (CE, 66 of 95 patients; THC, 65 of 100 patients; and PL, 33 of 48 patients) completed treatment. At baseline, groups were comparable for age (mean, 61 years), sex (54% men), weight loss (32% > or = 10%), PS (13% ECOG = 2), antineoplastic treatment (50%), appetite (mean VAS score, 31/100 mm), and QOL (mean score, 30/100). Intent-to-treat analysis showed no significant differences between the three arms for appetite, QOL, or cannabinoid-related toxicity. Increased appetite was reported by 73%, 58%, and 69% of patients receiving CE, THC, or PL, respectively. An independent data review board recommended termination of recruitment because of insufficient differences between study arms.

CONCLUSION

CE at the oral dose administered was well tolerated by these patients with CACS. No differences in patients' appetite or QOL were found either between CE, THC, and PL or between CE and THC at the dosages investigated.

Authors+Show Affiliations

Division of Oncology/Hematology, Department of Internal Medicine, Cantonal Hospital, St Gallen, Switzerland. florian.strasser@kssg.chNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16849753

Citation

Cannabis-In-Cachexia-Study-Group, et al. "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." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 24, no. 21, 2006, pp. 3394-400.
Cannabis-In-Cachexia-Study-Group, Strasser F, Luftner D, et al. 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;24(21):3394-400.
Strasser, F., Luftner, D., Possinger, K., Ernst, G., Ruhstaller, T., Meissner, W., ... Cerny, T. (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. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 24(21), pp. 3394-400.
Cannabis-In-Cachexia-Study-Group, et al. 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. PubMed PMID: 16849753.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - ,, AU - Strasser,Florian, AU - Luftner,Diana, AU - Possinger,Kurt, AU - Ernst,Gernot, AU - Ruhstaller,Thomas, AU - Meissner,Winfried, AU - Ko,You-Dschun, AU - Schnelle,Martin, AU - Reif,Marcus, AU - Cerny,Thomas, PY - 2006/7/20/pubmed PY - 2006/8/10/medline PY - 2006/7/20/entrez SP - 3394 EP - 400 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J. Clin. Oncol. VL - 24 IS - 21 N2 - PURPOSE: To compare the effects of cannabis extract (CE), delta-9-tetrahydrocannabinol (THC), and placebo (PL) on appetite and quality of life (QOL) in patients with cancer-related anorexia-cachexia syndrome (CACS). PATIENTS AND METHODS: Adult patients with advanced cancer, CACS, weight loss (> or = 5% over 6 months), and Eastern Cooperative Oncology Group (ECOG) performance status (PS) < or = 2 were randomly assigned (2:2:1) to receive CE (standardized for 2.5 mg THC and 1 mg cannabidiol) or THC (2.5 mg) or PL orally, twice daily for 6 weeks. Appetite, mood, and nausea were monitored daily with a visual analog scale (VAS); QOL was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (composite score: questions 29 and 30). Cannabinoid-related toxicity was assessed every 2 weeks. RESULTS: Of 289 patients screened, 243 were randomly assigned and 164 (CE, 66 of 95 patients; THC, 65 of 100 patients; and PL, 33 of 48 patients) completed treatment. At baseline, groups were comparable for age (mean, 61 years), sex (54% men), weight loss (32% > or = 10%), PS (13% ECOG = 2), antineoplastic treatment (50%), appetite (mean VAS score, 31/100 mm), and QOL (mean score, 30/100). Intent-to-treat analysis showed no significant differences between the three arms for appetite, QOL, or cannabinoid-related toxicity. Increased appetite was reported by 73%, 58%, and 69% of patients receiving CE, THC, or PL, respectively. An independent data review board recommended termination of recruitment because of insufficient differences between study arms. CONCLUSION: CE at the oral dose administered was well tolerated by these patients with CACS. No differences in patients' appetite or QOL were found either between CE, THC, and PL or between CE and THC at the dosages investigated. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/16849753/abstract/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 L2 - http://ascopubs.org/doi/full/10.1200/JCO.2005.05.1847?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -