Participants 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.

Participants 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.

Participants 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.

Breast Cancer

Nail Toxicity

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.

Onicolife nail drops

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).

Nail polish

Beatson Oncology Centre

Taxane Chemotherapy and Nail Toxicity in Women With Breast Cancer; Stage Two: Evaluation of Interventions

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).

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).

Evaluate any change in the patient's quality of life, in relation to nail problems occurring, as measured using the NToX-QoL (quality of life questionnaire).

Evaluate any change in the patient's quality of life, in relation to nail problems occurring, as measured using the EQ-5D-5L (quality of life questionnaire)

Assess collected data for any correlating relationship between nail grade severity (measured using NToX-G12 - outcome measure 1) and qualify of life (measured using NToX-QoL - outcome measure 3).

NHS Greater Glasgow and Clyde

Patients randomized to this arm will receive standard management alone for their minor procedure.

Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.

Standard Management

Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.
Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.

Nitrous Oxide

Total

Sex: Female, Male

Region of Enrollment

The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.

FLACC Pain Scale

Secondary outcome will be the Modified YALE Preoperative Anxiety Scale, measured pre-procedure, and intra-procedure. This is a validated scale measuring anxiety by assessment of Activity, Vocalization, Emotional Expressivity, State of Arousal and Use of Parents. All categories have a maximum score of 4 except for Vocalization with a maximum score of 6. The scores within each category are totaled and a total anxiety score is reported ranging from 5 (no anxiety) to 22 (highest level of anxiety).

M-YPAS Anxiety Scale

Another outcome measure is to compare the change in length of the procedure with or without nitrous oxide intervention.

Length of the Procedure

A parental survey was collected post-procedure regarding the overall comfort of the child during the procedure. Other questions included whether the procedure was successfully completed, if the procedure went better than expected, was the parent pleased with the medications used and whether the child tolerated the procedure. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. We chose the question that asked whether the child was comfortable during the procedure as it was most relevant. The categories "Strongly Agree" and "Agree" were combined in both groups.

Percentage of Parents Who Reported That Their Child Was Comfortable During the Procedure

Survey collection of rating of success of the procedure by one provider. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. The first two categories were combined.

Percentage of Providers Who Rated the Procedure as Being Successful

Overall Study

Dr. Sandra Cunningham

Laceration

Abscess

Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.

paronychia/повраћање

Taxane Chemotherapy and Nail Toxicity in Women With Breast Cancer; Stage Two: Evaluation of Interventions

Nitrous Oxide Use in Minor Procedures

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