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

NCT ID: NCT05855044

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2025-06-03

Brief 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.

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Rosemary oil

Group Type: EXPERIMENTAL

Rosemary oil application

Intervention Type: OTHER

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

Interventions

Rosemary oil application

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

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARCIM Institute Academic Research in Complementary and Integrative Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Vagedes, Dr.

Role: STUDY_DIRECTOR

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Locations

Arcim Institute

Filderstadt, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

CPN_01

Identifier Type: -

Identifier Source: org_study_id