An evaluative study on the safety and efficacy of standard anti-emetics compared to standard anti-emetics plus natural cannabinoids extract for the treatment of chemotherapy induced nausea and vomiting

Phase 2

Withdrawn

• Conditions: Emetogenicity; Chemotherapy induced nausea and vomiting; Cancer; Cancer - Any cancer

• Registration Number: ACTRN12615000414516
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Patients meeting all of the following inclusion criteria will be included in the study:
1)Chemotherapy-naive patients receiving moderate-highly emetogenicity chemotherapy.
2)Males and females equal to or greater than 18 years old.
3)Life expectancy >3 months.
4)ECOG performance status equal to or less than 2.
5)Baseline Karnofsky score >60.
6)No concurrent neoplasms or illness that induces nausea independent of chemotherapy.
7)No self-prescribed therapies or complimentary products used for nausea such as ginger.
8)Receiving serotonin 5HT3 or NK1 receptor antagonist medications.
9)Can be reasonably expected to be able to complete the CINV assessment tools.
10)Have provided written informed consent

Exclusion Criteria

1)Patients requiring radiotherapy.
2)Previous adverse reaction to or contraindicated to the standard anti-emetics proposed in the study.
3)Pregnant or breast-feeding.
4)Concurrent use of other cannabinoid-containing products.
5)History of adverse reactions to cannabinoids.
6)Patients with malignancies of gastrointestinal tract / gastrointestinal diseases or nausea and vomiting due to reasons other than chemotherapy.
7)Thrombocytopenia or patients undergoing chemotherapy that, according to physician discretion, is likely to cause thrombocytopenia (platelets <50 x 10^9/L).
8)Currently prescribed warfarin or on any other form of anti-coagulant therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified