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NCT Number: NCT07779135

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sensory and pain-related symptoms evolution measured with CIPN20

    Time frame: 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 outcomes

  1. Quality of life measured with EORTC QLQ C30

    Time frame: 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.

  2. Patient's perceived health status measured with PGI-C

    Time frame: 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).

  3. Anxiety and depression level measured with HAD

    Time frame: 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).

  4. Satisfaction, adherence and adverse events measured with a specific survey

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Karine Demesmay

CONTACT

[email protected]

+33 3 89 12 42 40

Magali Eyriey

CONTACT

+33 3 89 12 48 10

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Colmar

Other

Registry information

Official study title

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

Acronym: AROMA NEUROTAX

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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