Clinical trial NCT05855044: Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
Keywords: Chemotherapy-induced peripheral neuropathy
Oncological patients
Cancer
Chemotherapy
Rosemary oil
Lead sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Participation rate
timeFrame: When participation in the study is offered, before start of chemotherapy and rosemary oil application
Secondary outcomes:
measure: Rate of fully completed EORTC QLQ-CIPN20 questionnaires
timeFrame: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks
measure: Efficacy of rosemary oil according to EORTC QLQ-CIPN20 questionnaire
timeFrame: Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks
Other outcomes:
Locations:
city: Filderstadt
country: Germany
facility: Arcim Institute
state: Baden-Württemberg
Study officials:
affiliation: ARCIM Institute Academic Research in Complementary and Integrative Medicine
name: Jan Vagedes, Dr.
role: STUDY_DIRECTOR
References: