NIPH Clinical Trials Search

JRCT ID: jRCTs051220033

Registered date:27/05/2022

Effect of Anti-Oxident therapy for post-operative vocal fold sur gery: A clinical trial

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedLaryngeal cancer, vocal fold leukoplakia, carcinoma in situ, vo cal cord polyps, vocal fold cysts.
Date of first enrollment27/05/2022
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)(1) Protocol treatment period: (common to the test supplement intake group and the test supplement non-intake group) 7 days before surgery (Day-7) to 7 days after surgery (Day 8) (2) Test supplement intake group: They take the test supplement from 7 days before surgery (Day-7) and until 7 days after surgery (Day 8). If they are taken before 7 days before surgery (Day-7), the period from Day-22 to Day-8 is acceptable. (3) Subjects should keep a medication diary during the supple ment intake period. (4) The test supplement non-ingestion group does not take the test supplement.


Primary OutcomeVocal fold vibratory amplitude (VFVA) value 12 weeks after su rgery
Secondary Outcome(1) VFVA value 4 weeks after surgery. (2) Changes in VFVA value from 4 to 12 weeks after surgery. (3) Changes from the time of registration of the following mea sured values to 4 weeks and 12 weeks after surgery. Voice-handicap-index-10 GRBAS scale Maximum phonation time Mean flow rate Subglottic pressure Pitch perturbation quotient Amplitude perturbation quotient Intensity

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteriaEnroll patients who meet all of the following criteria: (1) Patients who are newly scheduled for phonomicrosurgery on suspicion of the following diseases: Laryngeal cancer, vocal fold leukoplakia, carcinoma in situ, vocal cord polyps, vocal fold cysts. However, the surgical side is only one side, and the excision range covers lesions and vocal fold mucosal epithe lium in all diseases. (2) Patients who are 20 years of age or older at the time of obtaining consent and who can obtain written consent from the patient. Gender does not matter. (3) The index of general condition is patients with Performanc e Status of 0 to 1.
Exclude criteriaThose who fall under any of the following are not included in this study. (1) Patients with history of surgery or radiation therapy for the larynx. (2) Patients with a history of treatment for laryngeal malignancies. (3) Patients with airway damage due to burns or burns. (4) Patients with severe heart disease or lung disease who complain of fatigue just by making a slightly effortful vocalization. (5) Patients with drug / alcohol dependence . (6) Patients who have difficulty following the instructions of the investigator, the doctor in charge, or the person in charge of examination. (7) In addition, patients who are judged to be inappropriate for participation in the study by the investigator / shared doctor.

Related Information


Public contact
Name Mami Kaneko
Address 465, Kajii-cho, Kamigyo-ku, Kyoto-shi, Kyoto-fu Kyoto Japan 6028566
Telephone +81-75-251-5603
Affiliation Kyoto Prefectural University of Medicine
Scientific contact
Name Shigeru Hirano
Address 465, Kajii-cho, Kamigyo-ku, Kyoto-shi, Kyoto-fu Kyoto Japan 6028566
Telephone +81-75-251-5603
Affiliation Kyoto Prefectural University of Medicine