Taxane Chemotherapy and Nail Toxicity in Women With Breast Cancer; Stage Two: Evaluation of Interventions
1 other identifier
interventional
105
1 country
1
Brief Summary
The study compares three strategies to prevent/minimise nail problems occuring in women, with breast cancer, undergoing Taxane chemotherapy. The strategies are: application of nail polish and normal care; application of Onicolife drops and normal care and; normal care only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Oct 2015
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedOctober 22, 2015
October 1, 2015
1 year
September 22, 2015
October 21, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Nail Assessment Scale
Evaluate nail interventions (nail polish + standard care Vs Onicolife drops + standard care Vs Standard Care only) that may prevent or minimise the occurrence and severity of nail problems measured using the NToX-G12 (Nail Assessment Scale).
6 months
Adverse Events
Evaluate nail interventions (nail polish + standard care Vs Onicolife drops + standard care Vs Standard Care only) that may prevent or minimise the occurrence and severity of nail problems measured using Common Terminology Criteria for Adverse Events v3.0 (CTC-AE v3).
6 months
Secondary Outcomes (3)
Quality of Life - NToX-QoL Health related quality of life questionnaire
6 months
Quality of Life - EQ-5D-5L Health related quality of life questionnaire
6 months
Quality of Life-nail grade severity relationship
6 months
Study Arms (3)
Control - standard care
NO INTERVENTIONParticipants will receive standard care regarding nail toxicity. This entails advice to keep nails trim and the provision of a nail oil to massage into the nail daily. Participants will also receive advice in relation to general healthy living.
Intervention - Oncolife drops
EXPERIMENTALParticipants will receive the same standard care as the control arm, except for the nail drops. The participants will also receive Onicolife nail drops to be applied twice daily.
Intervention - Nail polish
EXPERIMENTALParticipants will receive the same standard care as the control arm, except for the nail drops. The participants will also receive a dark coloured nail polish to be applied as instructed.
Interventions
The prescription free, CE (Conformité Européenne) marked product is for local application, and has a novel mode of action involving the modulation of mast cell action with the fatty acid amide, Adelmidrol ®. Mast cells are known to have a key role in the ability of the body to promote healing /repair and control tissue damage caused by chemo and radiotherapy. This includes damage to the nail and/ or nail matrix. OnicoLife ® thus helps to control inflammation and pain whilst antimicrobial action also provides antibacterial and antifungal support.
One dark colour of nail polish (deep burgundy/red) will be used in this study since this colour is considered more acceptable to many more women than a pure black coloured nail polish and hence, more likely to ensure compliance. No nail polish containing hardeners will be used since there is some evidence to suggest they can induce nail changes. As dark nail polish can stain the nail plate (and therefore mask any changes in nail pigmentation induced by chemotherapy), one clear base coat, two coats of coloured, and one clear top coat of polish will be required for each application. This standard of application is proposed as a gold standard for the prevention of nail staining and hypersensitivity reactions by an eminent podiatrist (Spalding, 2008).
Eligibility Criteria
You may qualify if:
- women over the age of 18 years who have been diagnosed with a breast cancer.
- must be receiving adjuvant or neo-adjuvant Taxotere chemotherapy for breast cancer.
- participants must be fluent English speakers to be eligible to take part, as there are no resources or additional funding for translators or interpreting services.
- Participants must provide informed consent.
You may not qualify if:
- Male patients with a diagnosis of breast cancer
- Patients who are non-fluent English speakers
- Patients with a known hypersensitivity reaction to nail/ relevant cosmetic products
- Previous treatment with taxane chemotherapy with the last two years
- Patients with only one upper limb.
- Patients with a neurological deficit to the upper limb (eg, stroke affecting one side)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beatson Oncology Centre
Glasgow, G12 0YN, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Audrey Morrison, Phd
NHS Greater Glasgow and Clyde
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2015
First Posted
October 22, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
April 1, 2017
Last Updated
October 22, 2015
Record last verified: 2015-10