Prospective, randomized clinical trial for the comparison of the voice protheses Phonax® and Provox II®

Not Applicable

• Conditions: C32.9; Z90; Larynx, unspecified; Acquired absence of organs, not elsewhere classified

• Registration Number: DRKS00006176
• Lead Sponsor: Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-21
• Study Completion: 2018-07-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

•histologically verified, primary resectable Larynx/Hypopharynxcarcinoma
•indikation for laryngectomy with primary creation of a tracheo esophageal fistula
•planned curative resection (R0-resection)
•stage II/IV A ollowing UICC (without T1)
•low to slightly enhanced risk of anesthesia
•adequate bone marrow-, liver- and kindneyfunction
•Karnofsky-Index =70%
•Age 18-80 Years
•written informed consent

Exclusion Criteria

•tumorspezifc pre-treatment (chemotherapy, radiation therapy)
•Metachrone or synchrone malignom (exception: basaliom or low-risk prostatecarcinoma) [In case of a controlled tumor at a different location with a treatment free intervall of more than 5 years, inclusion might be possible after consultation of the co-ordinating investigator]
•life expectancy < 6 months
•acute infection or fever
•anamnestic HIV-infection or othe immune suppression
•serious cardio-pulmonary concomittant disease (heart insufficiency grade III and IV following NYHA scale, myocardial infarction, angina pectoris, respiratoric insufficiency serious Asthma bronchiale, COPD (FEV1 <35%))
•chronic disease with permanent therapy (uncontrolled Diabetes, rheumatoide Arthritis) particularly steroid therapy
•other concomittant diseases, which exclude the patient from the trial from the perspective of the trial physician
•analphabetism
•intolerance regarding the materials of the voice protheses
•experienced low patient's compliance
•regular follow-up impossible (e. g. patient lives outside of Germany)
•lack of or patial legal capcity of the patient
•participation in another clinical trial or application of a not yet registered substancewithin 30 days before trial start
•pregnant or nursing
•fertile female patients (< 2 years after the last spontaneous menstruation) without effective contraception (implants, injections, oral contraceptives, intrauterine devices, vasectomized partner)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of voice protheses per year in the course of a three year follow-up with a maximum duration of stay of one year per prothesis.

Secondary Outcome Measures

Name	Time	Method
•3 year loco-regional control (staging, recurrence of tumor)<br>•symptomscore related to breathing-/ speaking- and swallowing ability <br>•complication rate related to the protheses /mediaclly documented (inspection of tracheostom, tracheoskopy with optics, way of insuffiziency, promblems with the fistula) during the 3 years of follow-up.<br>•funktioning of the voice protheses: PLTT (Post Laryngektomie Telefon Test), VHI (Voice Handicap Index), sound holding period 12, 24 and 36 months post surgery<br>•biofilm-parameterp: analysis of the voice prothesis after explantation by swab and microbiological analyses <br>•patient's quality of life (questionaires) 12, 24 and 36 monaths post surgery<br>•primary placement of the voice prothesis (questionaire for the surgeon)<br>•replacement of the voice prothesis (questionaire for the physician)