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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051220033
Enrollment
20
Registered
2022-05-27
Start date
2022-05-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal cancer, vocal fold leukoplakia, carcinoma in situ, vo cal cord polyps, vocal fold cysts. Laryngeal cancer, vocal fold leukoplakia, carcinoma in situ, vo cal cord polyps, vocal fold cysts.

Interventions

(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 supplemen
Andi-oxident

Sponsors

Hirano Shigeru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Vocal fold vibratory amplitude (VFVA) value 12 weeks after su rgery

Secondary

MeasureTime frame
(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

Contacts

Public ContactShigeyuki Mukudai

University Hospital Kyoto Prefectural University of Medicine

s-muku@koto.kpu-m.ac.jp+81-75-251-5603

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026