Evaluation of the efficacy of Trachyspermum ammi topical cream on taxane induced peripheral neuropathy symptoms in cancer patients : a pilot study

Evaluation of the effectiveness of topical cream on the symptoms of peripheral neuropathy caused by chemotherapy with taxanes in cancer patients

a parallel-group randomized clinical trial, Double-blinded

Forty patients with cancer, undergoing or have a history of chemotherapy with taxanes, were randomly diagnosed with peripheral neuropathy symptoms and inclusion criteria. There are two groups of drugs and placebo. Patients apply topical cream twice a day (morning and night) on all four lower and upper limbs, from the ankle to the toes, and from the wrist to the fingertips.

inclusion: Patients with cancer Patients whose neuropathy is due to chemotherapy with taxane drugs or a history of chemotherapy taxane that is a maximum of two months from completion of chemotherapy last Having symptoms of peripheral neuropathy Neuropathy is based on the diagnosis of a neurologist due to chemotherapy Aged between 18 and 80 years Willingness to collaborate in the study exclusion: diabetes Carpal tunnel syndrome Reluctance to stay in the study Acute psychological symptoms such as depression (taking medication for it) Unforeseen treatments such as surgery, radiation therapy, or immunotherapy that were not previously part of the participant's treatment plan Vitamin B6 deficiency or high (diagnosed by doctor and interview) Any signs of allergy or side effects from the drug Deterioration of the patient Renal failure Brain metastasis History of the axilla or lumbar or pelvic radiotherapy A history of neuropathy due to other conditions that the person had before starting chemotherapy or getting cancer

There are two intervention groups in this study, one group gets a Trachyspermum Ammi topical cream, and the other group receives the placebo ointment

pain tingling؛symptoms of peripheral neuropathy

In this study, the Restricted Randomization method of block randomization is used. Blocking is used to balance the number of samples assigned to each of the study groups. The randomization method will be balanced using block randomization and will be done in 4 blocks using a computer. Each drug is named with a number from 1 to 40. Patients are divided into two groups for the trial: the first and group (20 people) groups or drug groups and the second control group (20 people) placebo group. Both groups are equally divided in terms of characteristics and conditions. The control group is assigned to "A" and the intervention group to "B," and then these two groups are divided into 6 blocks of 4: (1)AABB, (2) BBAA, (3) ABAB, (4) B A B A, (5) A B B A, (6) BAAB. These blocks are randomly stacked together by a computer to form a chain of random groups (e.g., BBAA AABB ABAB BABA ABBA BAAB). Patients then enter these groups in the order of enrollment. For randomization, a randomization software for random sequence software called Random allocation software is used. In addition to simple randomization, this software can generate random sequences by block generation method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on the study participants. The assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are in the envelopes respectively. Are placed. To maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order, and the assigned group of the participant is revealed.

Trachyspermum ammi topical cream and placebo was coded, patient and researcher were blind