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Acetylamantadine Excretion by Cancer Patients

U

University of Manitoba

Status

Unknown

Conditions

Cancer

Treatments

Drug: Amantadine

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02277938
B2012:063

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: Any previous adverse reaction to Amantadine

  • currently pregnant or lactating

Trial design

120 participants in 1 patient group

Amantadine
Description:
Lung cancer patients being prescribed chemotherapy
Treatment:
Drug: Amantadine

Trial contacts and locations

1

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Central trial contact

Paramjit S Tappia, PhD; Andrew Maksymiuk, MD

Data sourced from clinicaltrials.gov

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