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Detection of taxane-induced neuropathy using patient-reported outcomes

Detection of taxane-induced neuropathy using patient-reported outcomes

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001378213
Enrollment
100
Registered
2018-08-16
Start date
2018-08-17
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

None listed

Brief summary

Many women receive chemotherapy to decrease the chance of breast cancer recurrence after surgery. These drugs include chemotherapy which is collectively termed taxane-based chemotherapy. Though this is effective in decreasing recurrence, it may cause adverse effects which include peripheral neuropathy, or damage to the nerves, particularly in the hands and feet. This nerve damage can be disabling, causing difficulty in work-related tasking such as typing on a keyboard, difficulty holding objects or fastening buttons. If severe, it can impair the ability to drive or cause falls. We hope to test a better way of detecting peripheral neuropathy than our current grading system, so that early symptoms can be identified and treatment changed to prevent this. Who is it for? You may be eligible for this study if you have a diagnosis of breast cancer and your oncologist plans to use weekly paclitaxel in your treatment plan. Study details If you participate, you will complete a form with details of pre-existing health problems and symptoms of neuropathy You will complete the neuropathy symptom tool (EORTC QLQ CIPN20) on cycle 1 day 1 of chemotherapy, then at 3, 6, 9, 12 weeks into your treatment There will be no additional visits. Your oncologist will not see the results of these questionnaires so if you have symptoms you should also discuss these with your oncologist in your clinic appointment. It is hoped this research will demonstrate that EORTC QLQ CIPN20 is more sensitive than standard practice, and could be used to identify neuropathy earlier that would allow modifications to treatment to be made before more severe symptoms develop.

Interventions

Patients with breast cancer who are receiving neoadjuvant or adjuvant chemotherapy which includes weekly paclitaxel may be eligible. Eligible patients will have enrolment discussed by their Oncology team. Details of pre-existing comorbidities and neuropathy will be collected for all consenting patients Patients will complete the EORTC QLQ CIPN20 questionnaire on cycle 1 day 1 of chemotherapy, then at the end of 3, 6, 9, 12 weeks

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Eligibility

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

Inclusion criteria

Patients receiving adjuvant or neoadjuvant weekly paclitaxel (80mg/m²) for the treatment of breast cancer; may be in combination with trastuzumab for HER2+ve patients

Exclusion criteria

Patient unable to complete CIPN20 in English

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026