Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN)

Effect of Aromatherapy on the Management of Chemotherapy-Induced Neuropathy (CIN) in Patients Receiving Taxane Therapy for Breast Cancer.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07779135

Acronym

AROMA NEUROTAX

Enrollment

Registered

2026-08-21

Start date

2026-07-15

Completion date

2027-09-15

Last updated

2026-08-21

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

Conditions

Breast Cancer, Neuropathic Pain in Cancer

Keywords

Chemotherapy-Induced Neuropathy, Breast cancer, Aromatherapy

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female patients with breast cancer * who have painful or bothersome CIN * occurring in the context of paclitaxel treatment (during or after treatment) * for whom conventional drug treatments provide insufficient relief (or are poorly tolerated or refused). * Age ≥ 18 years * Who, after receiving information, do not object to the use of their data for the purposes of this research

Exclusion criteria

* Pre-existing neuropathy (e.g., due to diabetes) * Known allergy to an essential oil or a component of essential oils (e.g., linalool) * Presence of wounds on the affected areas * Refusal to use aromatherapy * Inability to complete the questionnaires

Design outcomes

Primary

Measure	Time frame	Description
Sensory and pain-related symptoms evolution measured with CIPN20	At enrollment, Day 7 and Day 30 follow-up	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).

Secondary

Measure	Time frame	Description
Quality of life measured with EORTC QLQ C30	At enrollment, Day 7 and Day 30 follow-up	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.
Patient's perceived health status measured with PGI-C	At Day 7 and Day 30 follow-up	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).
Anxiety and depression level measured with HAD	At enrollment, Day 7 and Day 30 follow-up	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).
Satisfaction, adherence and adverse events measured with a specific survey	At Day 7 and Day 30 follow-up	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).

Countries

France

Contacts

CONTACTKarine Demesmay

karine.demesmay@ch-colmar.fr+33 3 89 12 42 40

CONTACTMagali Eyriey

+33 3 89 12 48 10

PRINCIPAL_INVESTIGATORKarine Demesmay

Hopitaux Civils de Colmar

PRINCIPAL_INVESTIGATOREmilie Hutt