Acetylamantadine Excretion by Cancer Patients

• Conditions: Cancer
• Interventions: Drug: Amantadine

• Registration Number: NCT02277938
• Lead Sponsor: University of Manitoba

Brief Summary

Several factors discourage the implementation of cancer screening to the population in general, which would result in earlier diagnosis and an expected improved survival. Concurrent in vivo and in vitro research has shown that drug acetylation activity is increased in cancer. Amantadine may be of value in detecting the presence of cancer. Accordingly, this study will examine how Amantadine is eliminated by the body in cancer patients. This is an important step in validating a cancer detection method that can be implemented economically for screening of large numbers of people.

Detailed Description

The study will involve the screening of volunteer patients with various types of cancer to provide a first indication of which types of cancer and at what stage of tumor burden acetylamantadine will be found in patients' plasma, saliva and urine samples. Volunteers will provide complete first morning urine collection prior to amantadine ingestion. The volunteers will then ingest a therapeutic dose of amantadine (200 mg: 2x100mg capsules), at least 2 hours before breakfast (nothing to eat or drink except water after midnight before the scheduled appointment), and their complete urine will be collected at 2 and 4 hours (plus or minus 1 hour) after amantadine ingestion. In addition, blood samples will be taken by venipuncture before and at 2 and 4 hours after drug ingestion. The patients will be asked to provide a saliva sample at the same time as the urine samples are taken after drug ingestion.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

newly diagnosed or untreated cancer (GI, lung, prostate and breast cancer)

Read More

Exclusion Criteria

Any previous adverse reaction to Amantadine

• currently pregnant or lactating

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Amantadine	Amantadine	Lung cancer patients being prescribed chemotherapy

Primary Outcome Measures

Name	Time	Method
Acetylated Amantadine levels in urine	2 and 4 hours after Amantadine ingestion	Change in acetylamantadine excretion

Trial Locations

Locations (1)

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada