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

JRCT ID: jRCTs051220033

Registered date:27/05/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Laryngeal cancer, vocal fold leukoplakia, carcinoma in situ, vo cal cord polyps, vocal fold cysts.
• Date of first enrollment: 27/05/2022
• Target sample size: 20
• Study type: Interventional

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.

Outcome(s)

Primary Outcome

Vocal 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 maximum: Not applicable
• Gender: Both

Include criteria

Enroll 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 criteria

Those 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

• Primary Sponsor: Hirano Shigeru
• Secondary ID(s): Nil known