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

Chemotherapy-induced Peripheral Neuropathy (CIPN) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855044
• Other study ID #: CPN_01
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: Jan Vagedes, Dr.
• Phone: +49 711 7703
• Email: j.vagedes[@]arcim-institute.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Arcim Institute	Filderstadt	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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