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Trial Title:
Efficacy of External Application of Rosemary Oil in Patients With Chemotherapy-Induced Peripheral Neuropathy: a Feasibility Study
NCT ID:
NCT05855044
Condition:
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Conditions: Official terms:
Peripheral Nervous System Diseases
Conditions: Keywords:
Chemotherapy-induced peripheral neuropathy
Oncological patients
Cancer
Chemotherapy
Rosemary oil
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Rosemary oil application
Description:
Application of Rosemary oil (10%) to both hands and both feet once a day for 24 weeks
Arm group label:
Rosemary oil
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arcim Institute
Address:
City:
Filderstadt
Zip:
70794
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jan Vagedes, Dr
Phone:
+497117703
Phone ext:
1688
Email:
j.vagedes@arcim-institute.de
Start date:
January 18, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Agency class:
Other
Source:
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05855044
