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Comparison of Neurotoxic Potential of Abraxane versus Oxaliplatin and Paclitaxel

Comparison of Neurotoxic Potential of Abraxane versus Oxaliplatin and Paclitaxel chemotherapy in cancer patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000921583
Enrollment
84
Registered
2015-09-03
Start date
2015-10-01
Completion date
2020-02-20
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The major focus of the study is to assess various key aspects of Abraxane-related neurotoxicity in cancer patients, including neurophysiological assessment to ascertain the prevalence and severity of neuropathy and careful assessment of the extent of functional impairment. Who is it for? You can join this study if you are aged 18-75 years and are scheduled to undergo chemotherapy with either one of the following drugs; abraxane, oxaliplatin or paclitaxel for the treatment of your cancer. Trial details In this study, the decision to commence abraxane treatment will be made by the treating oncologist rather than by the investigators. Measures of neuropathy severity, nerve function, quality of life and physical function will be obtained in all subjects at monthly intervals from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment. This study will provide information regarding the prevalence and functional impact of neuropathy as well as providing insights into the potential mechanisms of neurotoxicity due to Abraxane. Comparative testing in a cohort of patients treated with oxaliplatin and paclitaxel will provide information regarding the severity of neurotoxicity in abraxane-treated patients.

Interventions

Patients receiving abraxane chemotherapy for pancreatic cancer, breast cancer, colorectal cancer, non-small cell lung cancer or ovarian cancer will be recruited into the study to document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment. Examples of neurotoxicity seen with abraxane therapy include sensory dysasthesia including numbness and tingling in the hands and feet. Patients will be assessed monthly fro

Patients receiving abraxane chemotherapy for pancreatic cancer, breast cancer, colorectal cancer, non-small cell lung cancer or ovarian cancer will be recruited into the study to document the natural history of Abraxane-induced neurotoxicity through cross-sectional and prospective clinical and neurophysiological assessment. Examples of neurotoxicity seen with abraxane therapy include sensory dysasthesia including numbness and tingling in the hands and feet. Patients will be assessed monthly from the commencement of treatment until cessation, with 3-monthly follow up 6-12 months following cessation of treatment, to a maximum period of 2 years following enrolment.

Sponsors

South Eastern Local Health Network
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Receiving Abraxane chemotherapy, oxaliplatin chemotherapy or paclitaxel chemotherapy at designated study sites. 2. 18-75 years of age. 3. Able to provide written informed consent. 4. For Abraxane-treated patients, histological or cytological confirmation of breast, non-small cell lung, ovarian or pancreatic cancer 5. For paclitaxel and oxaliplatin- treated patients, histological or cytological confirmation of breast, ovarian, pancreatic or colorectal cancer.

Exclusion criteria

1. Clinical symptoms of pre-existing neuropathy. 2. Concurrent use of other neuromodulating agents (e.g. carbamazepine, topiramate, phenytoin), which may confound interpretation of excitability data. 3. Significant neurological or psychiatric disorders.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026