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

NCT05855044 | Completed

• 1 other identifier: CPN_01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Keywords

Chemotherapy-induced peripheral neuropathy; Oncological patients; Cancer; Chemotherapy; Rosemary oil

Outcome Measures

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.

  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

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

• Efficacy of rosemary oil according to EORTC QLQ-CIPN20 questionnaire

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

Study Arms (1)

Rosemary oil

EXPERIMENTAL

Other: Rosemary oil application

Interventions

Rosemary oil application OTHER

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

Rosemary oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ARCIM Institute Academic Research in Complementary and Integrative Medicine: lead

Study Sites (1)

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jan Vagedes, Dr.

  ARCIM Institute Academic Research in Complementary and Integrative Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: January 18, 2024
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be made available upon publication for a duration of three months.
• Access Criteria: The data will be made available to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.

Locations

DE (1)