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

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Intervention / Treatment: Other: Rosemary oil application

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Vagedes, Dr.; Phone Number: 1688 +49 711 7703; Email: j.vagedes@arcim-institute.de

Study Locations

• Germany
  • Baden-Württemberg
    • Filderstadt, Baden-Württemberg, Germany, 70794
      • Recruiting
      • Arcim Institute
      • Contact: Jan Vagedes, Dr; Phone Number: 1688 +497117703; Email: j.vagedes@arcim-institute.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosemary oil	Other: Rosemary oil application; Application of Rosemary oil (10%) to both hands and both feet once a day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Investigators: Study Director: Jan Vagedes, Dr., ARCIM Institute Academic Research in Complementary and Integrative Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Chemotherapy; Chemotherapy-induced peripheral neuropathy; Oncological patients; Rosemary oil
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: CPN_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data will be made available, in addition to study protocol and informed consent form.
• IPD Sharing Time Frame: The data will be made available upon publication for a duration of three months.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No