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Study aim:
The effect of topical herbal oil based on lavender, Acorus calamus and Turmeric on Taxanes - induced peripheral neuropathy in cancer patients and control group
Design:
A controlled, double-blind, randomized, phase 2 clinical trial with parallel group, on 75 patients.
The rand function of Excel software was used for randomization.
Settings and conduct:
The location is the Radio-Oncology department of Mahdieh Hospital
The control group received 1 cc of placebo oil three times a day, and the intervention group received 6 cc of herbal oil on the surface of the feet and hands.
Drug; glass containers with a dropper of one shape and the name of the product as a code
Duration of the intervention is 4 weeks, drug test 24 hours before use
Participants/Inclusion and exclusion criteria:
A 4-week double-blind randomized clinical trial of 74 volunteer patients, 18-80 years of age, patients with breast, gynecological and urological cancer inTehran Mahdieh Hospital, with peripheral neuropathy, response to treatment, assessment of improvement in the scores of the NPS, the FACT/GOG-Ntx, PNQ scale by a physician
Intervention groups:
Entry criteria
• Having cancer with a pathological answer
• undergoing chemotherapy or completed chemotherapy within the last two months
• Patients with neuropathy, as determined by a neurologist, due to Taxanes chemotherapy
• Having peripheral neuropathy of lower or upper limbs or both
• Having at least Grade B neuropathy based on the PNQ questionnaire
• Not having Guillain-Barre, diabetes, multiple sclerosis and carpal tunnel syndrome
• Age 18 - 80
• Willingness to collaborate on the project
• Insensitivity to herbal medicines
• Stage 1 to 3 patients
• No amputations or no wounds on hands and feet
• Not having skin cancer
• no concurrent radiotherapy
Main outcome variables:
Sensory and motor disorders of upper and lower limbs, neuropathic pain, symptoms of neuropathy