Chemotherapy Nail Toxicity: Evaluation of Interventions.
Research type
Research Study
Full title
Taxane Chemotherapy and Nail Toxicity in Women with Breast Cancer; Stage Two: Evaluation of Interventions.
IRAS ID
161578
Contact name
Audrey Morrison
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Nail changes associated with chemotherapy are under reported in terms of incidence and severity (Minisini et al, 2003). Taxane chemotherapy improves clinical response however, it results in more nail toxicity changes. Nail toxicity may vary in appearance, severity and function. Nail toxicity is currently assessed using the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. However, this tool has previously been criticised for being insufficient for accurate reporting of type and grades of adverse effects (Chen et al, 2012). Therefore, in stage one, the NToX-G12 Nail Assessment Scale, the Master Guide (photographs and descriptions of nail problems) and the NToX-QoL (patient quality of life questionnaire in relation to nail condition) were developed with patients, clinicians and expert reviewers.
Following on with stage two (this study), we now seek approval to provide initial evidence that either, or both interventions (dark nail polish + standard care or Onicolife drops + standard care) when compared to standard care alone, can prevent or minimise the occurrence and severity of nail problems arising from the side effects of taxotere chemotherapy. The outcome measures developed in stage one will be used to evaluate the interventions along with the usual CTCAE v3 and EQ-5D-5L (Quality of Life questionnaire).
Patients diagnosed with breast cancer to receive taxane based chemotherapy will be recruited prior to commencement of chemotherapy from Beatson West of Scotland/Greater Glasgow and Clyde. The patient's nail condition will be assessed at three time points; pre-assessment cycle 2 [Baseline assessment], post treatment 3 weeks (+/- 3 weeks) at their routine appointment with the clinician [second assessment]; and post treatment 3 months (+/- 3 weeks)[final assessment], which will require an additional visit.
REC name
South East Scotland REC 02
REC reference
15/SS/0172
Date of REC Opinion
19 Oct 2015
REC opinion
Further Information Favourable Opinion