Chemotherapy-induced Peripheral Neuropathy (CIPN)NCT05855044
Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility Study
A study testing Rosemary oil application in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Rosemary oil application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2024to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy - a Monocentre, Single-arm Non-controlled Feasibility Study to Assess the Feasibility of Evaluating Topical Applications in CIPN
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.
- Being tested
- Rosemary oil application
- Keywords
- Chemotherapy-induced peripheral neuropathy, Oncological patients, Cancer, Chemotherapy, Rosemary oil
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosemary oil applicationOther
Application of Rosemary oil (10%) to both hands and both feet once a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rosemary oil | Experimental | Not described Receives: Other: Rosemary oil application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: When participation in the study is offered, before start of chemotherapy and rosemary oil application
Secondary outcomes (2)
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).
Measured: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks
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).
Measured: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start18 Jan 2024
- Primary completion3 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Vagedes, Dr., Study director, ARCIM Institute Academic Research in Complementary and Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855044
- Sponsor's protocol ID
- CPN_01
- Status last verified
- Jun 2025
- First submitted
- 3 May 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy - a Monocentre, Single-arm Non-controlled Feasibility Study to Assess the Feasibility of Evaluating Topical Applications in CIPN
- ClinicalTrials.gov ID
- NCT05855044
- Acronym / sponsor ID
- CPN_01
- Keywords
- Chemotherapy-induced peripheral neuropathy, Oncological patients, Cancer, Chemotherapy, Rosemary oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ARCIM Institute Academic Research in Complementary and Integrative MedicineUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosemary oil | Experimental | Other: Rosemary oil application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosemary oil applicationApplication of Rosemary oil (10%) to both hands and both feet once a day for 24 weeks | Other | Rosemary oil |
Primary outcome
Participation rate
Time frame: When participation in the study is offered, before start of chemotherapy and rosemary oil application
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.
2 secondary outcomes
Rate of fully completed EORTC QLQ-CIPN20 questionnaires
Time frame: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks
Efficacy of rosemary oil according to EORTC QLQ-CIPN20 questionnaire
Time frame: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Vagedes, Dr. study director
ARCIM Institute Academic Research in Complementary and Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosemary oil application in people with Chemotherapy-induced Peripheral Neuropathy (CIPN), run by ARCIM Institute Academic Research in Complementary and Integrative Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: When participation in the study is offered, before start of chemotherapy and rosemary oil application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.