The main objective of this study is to describe the effect of an essential oil-based blend applied topically in the management of painful symptoms, sensory disturbances, or functional impairment caused by Chemotherapy-Induced Neuropathy (CIN) in breast cancer patients who have undergone paclitaxel treatment.
Study Type
OBSERVATIONAL
Enrollment
80
Hôpitaux Civils de Colmar
Colmar, France
RECRUITINGSensory and pain-related symptoms evolution measured with CIPN20
The CIPN20 (Chemotherapy-Induced Peripheral Neuropathy) questionnaire is a 20-item questionnaire used to assess and monitor symptoms, specifically targeting chemotherapy-induced neuropathies. We will limit ourselves to items 31 through 44, which concern sensory and pain-related symptoms. Items 31-36, 39, and 40 address sensory symptoms and problems. Items 37, 38, 41-44 address motor symptoms and problems. The individual items should be scored such that higher scores represent more symptoms/problems (i.e., higher score = worse).
Time frame: At enrollment, Day 7 and Day 30 follow-up
Quality of life measured with EORTC QLQ C30
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: At enrollment, Day 7 and Day 30 follow-up
Patient's perceived health status measured with PGI-C
The patient's perceived health status will be assessed using the Patients' Global Impression of Change questionnaire (PGI-C). PGI-C is the PRO counterpart to the Clinical Global Impressions scale, (CGI), which was published in 1976 by the National Institute of Mental Health (US). PGI-C is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved" (1 point), "much improved" (2 points), "minimally improved" (3 points), "no change" (4 points), "minimally worse" (5 points), "much worse" (6 points) or "very much worse" (7 points).
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Time frame: At Day 7 and Day 30 follow-up
Anxiety and depression level measured with HAD
The HAD Scale is a tool used to screen for anxiety and depressive disorders. It consists of 14 items scored on a scale of 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), resulting in two scores (maximum score for each = 21).
Time frame: At enrollment, Day 7 and Day 30 follow-up
Satisfaction, adherence and adverse events measured with a specific survey
A survey on satisfaction, adherence and adverse events will be conducted using a specific qualitative questionnaire that employs a Likert scale for certain items (acceptance, satisfaction). For acceptance, a 4-point scale of likert will be used : 1 = "Strongly agree", 2 = "Agree", 3 = "Disagree", 4 = "Strongly disagree". For overall satisfaction, a 6-point scale will be used, ranging from 1 (very dissatisfied) to 6 (very satisfied).
Time frame: At Day 7 and Day 30 follow-up