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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05855044

Studienbeginn:
Januar 2024

Letztes Update:
19.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Peripheral Nervous System Diseases

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborator:
-

Studienleiter

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

Kontakt

Studienlocations
(1 von 1)

Arcim Institute
70794 Filderstadt
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Jan Vagedes, Dr
Phone: +497117703
Phone (ext.): 1688
E-Mail: j.vagedes@arcim-institute.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Participation rate (Time Frame - When participation in the study is offered, before start of chemotherapy and rosemary oil application):
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.



Secondary outcome:

1. Rate of fully completed EORTC QLQ-CIPN20 questionnaires (Time Frame - Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks):
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).

2. Efficacy of rosemary oil according to EORTC QLQ-CIPN20 questionnaire (Time Frame - Before start of chemotherapy and rosemary oil application (baseline), then weekly for 24 weeks):
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).

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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