Predicting Nerve Damage Induced by Chemotherapy

Biological correlates of chemotherapy-induced neurotoxicity: a prospective cohort study of cancer patients undergoing treatment with cisplatin, oxaliplatin or paclitaxel. Prospectively Investigating Chemotherapy Neurotoxicty

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12612000029897

Acronym

PICNic

Enrollment

300

Registered

2012-01-09

Start date

2011-08-30

Completion date

2016-09-28

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This is a study that will collect information about patient neurotoxicity outcomes after treatment with cisplatin, oxaliplatin and paclitaxel chemotherapy, for correlation with biological variables measured in blood samples collected at baseline or during the initial course of treatment. The study population will include adult patients with any cancer type, who will have standard chemotherapy with cisplatin, oxaliplatin or paclitaxel, who are able to give informed consent, who are over 18 years old and who are expected to survive for more than six months. The patient neurotoxicity outcomes to be measured in this study include the change between baseline and three months after treatment in the Total Neuropathy Score Clinical, which is a clinical test, the neurotoxicity quality of life score, which is a questionnaire, the severity grade for hearing toxicity, measured by an audiogram and the occurrence of treatment-limiting neurotoxicity. Samples of blood will be collected at baseline, on cycle 1 day 1 and at the end of cycle 1 for preparation of plasma RNA and DNA biomarker samples. There will be 300 patients in total and in each group at least 100 patients.

Interventions

This study is observing the effect of standard chemotherapies Oxaliplatin , cisplatin and paclitaxel on neurotoxicity. These chemotherapy treatments are given intravenously through a wide range of doses, patients may have 3 or 4 weekly cycles that may continue for between 4 and 10 cycles. This observational study will last approximately 6 months.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Written informed consent Inclusion criteria All adult male or female patients with cancer of any type presenting for standard chemotherapy that includes cisplatin, oxaliplatin or paclitaxel are candidates for study participation.

Exclusion criteria

Exclusion criteria Unable for give informed consent Expected survival less than 6 months Age less than 18 years

Outcome results