CClinicalTrials.gg
CompletedNCT05855044Updated Jun 4, 2025

Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility Study

An interventional study of Rosemary oil application in Chemotherapy-induced Peripheral Neuropathy (CIPN), sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by ARCIM Institute Academic Research in Complementary and Integrative Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Chemotherapy can cause sensory disorders in the hands and feet called peripheral neuropathy. Typical symptoms are pain, loss of sensation, tingling, numbness, and gait disturbances, which worsen patients' quality of life and increase the risk of falls. Little is known about the effect of rosemary oil (applied to hands and feet) on the symptoms of neuropathy. The present study is a feasibility study to see if it is possible to conduct a clinical trial in patients diagnosed with cancer and receiving chemotherapy who report peripheral neuropathy and apply rosemary oil to their hands and feet.

Read the detailed description

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common severe dose-limiting side effects that accompany treatment with different chemotherapeutic agents. Patients with CIPN often experience a reduction in quality of life and an increase in fall risk due to symptoms such as pain, sensory loss, paresthesia (tingling, numbness), and gait disturbances. Treatment of CIPN is based on pharmacotherapy, which may in turn cause side effects such as nausea, dizziness, fatigue and others. In addition, various approaches from integrative medicine are used, e.g. acupuncture, touch therapies, mind-body medicine, dietary supplements, and aromatherapy. Little is known about the effect of rosemary oil, applied to hands and feet, on CIPN. The present study is a feasibility study to determine the feasibility of a future clinical trial to investigate the efficacy of topical application of rosemary oil in cancer patients undergoing chemotherapy who develop CIPN.

02

Conditions studied

  • Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

  • Chemotherapy-induced peripheral neuropathy
  • Oncological patients
  • Cancer
  • Chemotherapy
  • Rosemary oil
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent
  • Age 18 years or older
  • Cancer diagnosis
  • Assignment to neurotoxic chemotherapy that has not yet started at the time of enrolment
  • Intact, irritation-free skin on the hands and feet
  • No history of neuropathic pain

Exclusion criteria

Exclusion Criteria:

  • Neurorelevant comorbidities such as diabetes or alcohol abuse
  • Use of medication for neuropathy such as gabapentin, pregabalin, venlafaxine or duloxetine
  • Other relevant treatments for CIPN during the study
  • Insufficient knowledge of the German language
  • History of rosemary oil allergy
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Rosemary oil

    Other: Rosemary oil application

Interventions

  • OtherRosemary oil application

    Application of Rosemary oil (10%) to both hands and both feet once a day for 24 weeks

05

What researchers measure

Primary outcomes

  1. Participation rate

    Participation rate in relation to all eligible patients and the reasons for non-participation. Reasons for refusal to participate in the study will be recorded.

    Time frame: When participation in the study is offered, before start of chemotherapy and rosemary oil application

Secondary outcomes

  1. Rate of fully completed EORTC QLQ-CIPN20 questionnaires

    The rate of fully completed EORTC QLQ-CIPN20 questionnaires in relation to incomplete questionnaires and reasons for missing data. EORTC QLQ-CIPN20 is used to measure the severity of CIPN pain and functional symptoms. It includes 20 items in three subscales to evaluate sensory (9 items), autonomic (3 items) and motor (8 items) symptoms and function. Each item is rated on a four-point Likert scale from 1 (not at all) to 4 (very much). Scores are summed up to a total score, which is linearly converted to a scale of 0-100 (a high score means more symptoms and pain).

    Time frame: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks

  2. Efficacy of rosemary oil according to EORTC QLQ-CIPN20 questionnaire

    Efficacy of rosemary oil in order to obtain a basis for a sample size calculation in a follow-up study. Effect of rosemary oil application will be measured using the EORTC QLQ-CIPN20 questionnaire. EORTC QLQ-CIPN20 is used to measure the severity of CIPN pain and functional symptoms. It includes 20 items in three subscales to evaluate sensory (9 items), autonomic (3 items) and motor (8 items) symptoms and function. Each item is rated on a four-point Likert scale from 1 (not at all) to 4 (very much). Scores are summed up to a total score, which is linearly converted to a scale of 0-100 (a high score means more symptoms and pain).

    Time frame: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks

06

Study locations

1 site
  • Arcim Institute
    Filderstadt, Baden-Württemberg 70794, Germany
07

References and documents

Individual participant data

Plan to share: Yes — Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05855044
Lead sponsor
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Responsible party
Sponsor
First posted
May 11, 2023
Start date
Jan 18, 2024
Primary completion
Jun 3, 2025
Completion
Jun 3, 2025
Last update
Jun 4, 2025

Study contacts

Jan Vagedes, Dr.
study director · ARCIM Institute Academic Research in Complementary and Integrative Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion