Randomized controlled trial on postoperative pulmonary humidification after total laryngectomy: external humidifier versus heat and moisture exchanger.

Objectives/hypothesis: Assessment of immediate postoperative airway humidification after total laryngectomy (TLE), comparing the use of an external humidifier (EH) with humidification through a heat and moisture exchanger (HME).

Study Design: Randomized controlled trial (RCT).

Methods: Fifty-three patients were randomized into the standard (control) EH (N = 26) or the experimental HME arm (N = 27).

Five-year quality of life results of the randomized clinical phase III (RADPLAT) trial, comparing concomitant intra-arterial versus intravenous chemoradiotherapy in locally advanced head and neck cancer.

Background: The purpose of this investigation was to present 5-years of quality-of-life (QOL) results of a multicenter randomized phase III trial, assessing intra-arterial (IA) versus standard intravenous (IV) chemoradiation for inoperable stage IV head and neck cancer.

Methods: Evaluation of 71 patients through European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module (EORTC QLQ-C30) and Head and Neck Module (QLQ-H&N35), and trial-specific questionnaires. Treatment consisted of standard radiotherapy with 4 weekly IA or 3 weekly IV cisplatin infusions.

Integration of a smoking cessation program in the treatment protocol for patients with head and neck and lung cancer.

Smoking is the main causative factor for development of head and neck and lung cancer. In addition, other malignancies such as bladder, stomach, colorectal, kidney and pancreatic cancer have a causative relation with smoking. Continued smoking after having been diagnosed with cancer has many negative consequences: effectiveness of radiotherapy is diminished, survival time is shortened and risks of recurrence, second primary malignancies and treatment complications are increased.

A new heat and moisture exchanger for laryngectomized patients: endotracheal temperature and humidity.

Objective: To assess the endotracheal temperature and humidity and clinical effects of 2 models of a new heat and moisture exchanger (HME): Rplus, which has regular breathing resistance, and Lplus, which has lower breathing resistance.

Methods: We measured endotracheal temperature and humidity in 10 laryngectomized patients, for 10 min each, with and without the HMEs. We sequentially tested 4 HME models (all Atos Medical, Hörby, Sweden), in randomized order: Rplus, Lplus, Provox Normal (the HME we regularly use and which we considered the reference HME), and Stomvent (an older HME model).

Prospective clinical phase II study of two new indwelling voice prostheses (Provox Vega 22.5 and 20 Fr) and a novel anterograde insertion device (Provox Smart Inserter).

Objectives/hypothesis: To assess device life of the new Provox Vega 22.5 and 20 Fr prostheses, to establish whether the optimized airflow characteristics of these devices materialize in better voice characteristics in comparison to Provox2, and to assess the feasibility of voice prosthesis replacement with the new Smart Inserter.

Study Design: Prospective clinical phase II study.

Intra-arterial versus intravenous chemoradiation for advanced head and neck cancer: Results of a randomized phase 3 trial.

Background: Chemoradiation is the preferred treatment for advanced stage IV head and neck cancer. Higher doses of chemotherapy yielded promising results in vitro and vivo, confirmed by intra-arterial (IA) cisplatin-based chemoradiation in phase 2 studies.

Methods: Two hundred and thirty-nine patients with (functionally) unresectable head and neck cancer were included, from 2000 to 2004, in a multicenter, randomized phase 3 trial, comparing IA and intravenous chemoradiation.

Short-term endotracheal climate changes and clinical effects of a heat and moisture exchanger with an integrated electrostatic virus and bacterial filter developed for laryngectomized individuals.

Conclusion: Both the regularly used heat and moisture exchanger (R-HME) and the HME with both an antimicrobial and hygroscopic element (F-HME) are effective moisture exchangers. The antimicrobial filter of the F-HME acts as a heat exchanger. The external features of the F-HME were experienced as inconvenient, but decreased sputum production was reported as well.

Pretreatment organ function in patients with advanced head and neck cancer: clinical outcome measures and patients' views.

Background: Aim of this study is to thoroughly assess pretreatment organ function in advanced head and neck cancer through various clinical outcome measures and patients' views.

Methods: A comprehensive, multidimensional assessment was used, that included quality of life, swallowing, mouth opening, and weight changes. Fifty-five patients with stage III-IV disease were entered in this study prior to organ preserving (chemoradiation) treatment.

Clinical phase I/feasibility study of the next generation indwelling Provox voice prosthesis (Provox Vega).

Conclusions: Provox Vega prostheses demonstrate good short-term feasibility, and their optimized airflow-resistance design offers laryngectomy patients indwelling voice prostheses with more choices in outer diameters without sacrificing (too) much in voice quality.

Objectives: Technological progress enables improvement of in vitro airflow characteristics of voice prostheses and design of voice prostheses with smaller outer diameters. This could potentially improve voice quality in users of Provox2, and avoid diminished voice quality in users of prostheses with smaller outer diameters.

The effect of a Heat and Moisture Exchanger (Provox HME) on pulmonary protection after total laryngectomy: a randomized controlled study.

The goal of this randomized controlled study was to investigate the effect of Heat and Moisture Exchanger use on pulmonary symptoms and quality of life aspects in laryngectomized patients. Eighty laryngectomized patients were included and randomized into an HME and Control group. The effect of the HME was evaluated by means of Tally Sheets and Structured Questionnaires.

Parotid gland sparing IMRT for head and neck cancer improves xerostomia related quality of life.

Background And Purpose: To assess the impact of intensity modulated radiotherapy (IMRT) versus conventional radiation on late xerostomia and Quality of Life aspects in head and neck cancer patients. PATIENTS AND NETHODS: Questionnaires on xerostomia in rest and during meals were sent to all patients treated between January 1999 and December 2003 with a T1-4, N0-2 M0 head and neck cancer, with parotid gland sparing IMRT or conventional bilateral neck irradiation to a dose of at least 60 Gy, who were progression free and had no disseminated disease (n = 192). Overall response was 85% (n = 163); 97% in the IMRT group (n = 75) and 77% in the control group (n = 88) the median follow-up was 2.

First-year quality of life assessment of an intra-arterial (RADPLAT) versus intravenous chemoradiation phase III trial.

Background: We report the results of a multicenter randomized phase III study, assessing quality of life (QOL) in intra-arterial (IA) versus standard intravenous (IV) chemoradiation in advanced head and neck cancer.

Methods: Two hundred seven patients with inoperable stage IV disease-152 men and 55 women; mean age, 55 years-were included in this study. The patients were treated with standard radiotherapy with 4 weekly IA or 3 weekly IV cisplatin infusions.

A thin tracheal silicone washer to solve periprosthetic leakage in laryngectomies: direct results and long-term clinical effects.

Objectives: Assessment of the immediate results and long-term clinical effects of a thin silicone washer placed behind the tracheal flange of voice prostheses to treat periprosthetic leakage.

Patients And Methods: Three year retrospective analysis of 32 laryngectomized patients with 107 periprosthetic leakage events (PLEs). Custom-made silicone washers (outer diameter 18 mm, inner diameter 7.

Long-term results of Provox ActiValve, solving the problem of frequent candida- and "underpressure"-related voice prosthesis replacements.

Objectives: To assess the long-term results of the Provox ActiValve, a prosthesis for voice rehabilitation after total laryngectomy that was designed to lessen the need for frequent replacements caused by Candida and "underpressure."

Patients And Methods: Retrospective assessment of device lifetime, indications for replacement, voice quality, and maintenance issues, measured by a structured trial specific questionnaire, in a cohort of 42 laryngectomized patients, experiencing a short Provox2 device lifetime (median, 21 days).

Results: The median device lifetime of Provox ActiValve, replaced for leakage through the device and those still in situ at the date of data collection (N = 32), was 337 days (mean 376 days): a statistically significant 16-fold increase compared to the Provox2 prosthesis (P < .

The psychological impact of annual chest X-ray follow-up in head and neck cancer.

Conclusion: Annual post-treatment screening of head and neck squamous cell carcinoma (HNSCC) patients for second primary lung cancer and metastatic recurrence appeared to form no major burden for head and neck cancer patients. A majority of patients regard the annual chest X-ray as a reassurance. Given these results a more intensive screening program seems psychologically justifiable for this group.

Development and evaluation of a novel tracheostoma button and fixation system (Provox LaryButton and LaryClip adhesive) to facilitate hands-free tracheoesophageal speech.

Conclusion: This newly developed tracheostoma button and fixation system was appreciated by the majority of the patients in this study and led to an increased use of automatic speaking valves (ASVs).

Objective: Development and prospective clinical evaluation of a new tracheostoma button and fixation system to enhance hands-free speech in laryngectomized patients.

Patients And Methods: The Provox LaryButton and LaryClip adhesive system were prospectively evaluated in 11 patients: 10 male, 1 female; mean age 60.

Hands-free speech after surgical voice rehabilitation with a Provox voice prosthesis: experience with the Provox FreeHands HME tracheostoma valve system.

Excellent results have been reported with the use of voice prostheses for the rehabilitation of laryngectomees. Patients, however, consider it a disadvantage that the tracheostoma must be closed manually for speech production. This limits their ability to simultaneously communicate by gesture or to work with both hands.

Compliance, quality of life and quantitative voice quality aspects of hands-free speech.

Conclusions: With the use of a new automatic stoma valve (ASV) it appears possible to rehabilitate patients who have previously been unsuccessful in acquiring hands-free speech. As well as making daily ASV use possible for an additional group of patients, this new device was also appreciated by many patients as an additional rehabilitation tool for specific occasions. Despite statistically significant improvements in aspects of voice and breathing using this novel ASV, improvement of peristomal adhesion is probably the main factor needed to further increase success rates.

Quality of life assessment in laryngectomized individuals: do we need additions to standard questionnaires in specific clinical research projects?

Objectives: To assess, whether the EORTC questionnaires QLQ-C30 and QLQ-H&N35 give enough detailed information to study specific quality of life (QoL) related issues in laryngectomized individuals.

Design: Multicentre, prospective clinical trial; baseline measurement with EORTC questionnaires and an additional questionnaire, focusing on specific postlaryngectomy problems.

Setting: Head and Neck Department of one Comprehensive Cancer Center and three Academic Medical Hospitals in the Netherlands.

High-dose superselective intra-arterial cisplatin and concomitant radiation (RADPLAT) for advanced head and neck cancer.

Background: The purpose of this study was to study the effect of intensive targeted chemoradiation in a group of patients with head and neck cancer with stage IV inoperable disease.

Methods: We examined 79 patients with inoperable stage IV head and neck cancer receiving intra-arterial infusion of high-dose cisplatin (150 mg/m(2)) on days 2, 9, 16, and 23 concomitant with delivery of external beam radiotherapy (total dose, 70 Gy; 2 Gy, 35 fractions; 1 fraction/day for 7 weeks). Sodium thiosulfate was administered intravenously to provide effective cisplatin neutralization.

Multicenter study assessing effects of heat and moisture exchanger use on respiratory symptoms and voice quality in laryngectomized individuals.

Objective: A multicenter study based in the United States assessed the heat-moisture exchanger effect on respiratory symptoms and "voice quality" of laryngectomees. PATIENTS AND MEASURES: The study group consisted of 81 consecutive laryngectomees (62 men and 19 women; mean age, 66 years; age range, 45 to 89 years), with a median follow-up of 3.5 years (range, 0.

A new problem-solving indwelling voice prosthesis, eliminating the need for frequent Candida- and "underpressure"-related replacements: Provox ActiValve.

Objectives: To develop and clinically assess a new prosthesis for voice rehabilitation after total laryngectomy that solves the problem of frequent Candida- and "underpressure"-related replacements.

Material And Methods: We designed a voice prosthesis with a new valve mechanism, applying Candida-resistant fluoroplastic (Teflon-like) material for the valve and valve seat and magnets to generate an active closing force, preventing inadvertent opening of the valve during swallowing or deep inhalation. Several prototypes were tested in 13 laryngectomized patients and, subsequently, the final design was assessed in a prospective clinical trial in a cohort of 18 patients with a short device lifetime of their standard indwelling voice prosthesis (mean 30 days).

Development and clinical assessment of a heat and moisture exchanger with a multi-magnet automatic tracheostoma valve (Provox FreeHands HME) for vocal and pulmonary rehabilitation after total laryngectomy.

Objective: To develop and test the prototypes of a novel post-laryngectomy rehabilitation tool incorporating an obligatory, disposable heat and moisture exchanger (HME) and a reusable, multi-magnet automatic speaking valve (ASV).

Material And Methods: The study subjects comprised 20 laryngectomized individuals (15 males, 5 females), 5 of whom were already using an ASV and 15 who were not. Three successive prototypes were tested.

Quality-of-life assessment after supradose selective intra-arterial cisplatin and concomitant radiation (RADPLAT) for inoperable stage IV head and neck squamous cell carcinoma.

Objective: To evaluate quality-of-life (QOL) aspects of an organ preservation intra-arterial chemotherapy and concomitant radiation protocol, RADPLAT.

Design: Nonrandomized phase 2B feasibility trial.

Patients: Fifty consecutive patients with inoperable stage IV head and neck cancer.

Pulmonary function pre- and post-total laryngectomy.

Pulmonary function pre- and post-total laryngectomy was assessed in 16 patients without overt inspiratory stridor preoperatively. It could be shown that total laryngectomy is associated with a significant decrease in vital capacity and in an increase in inspiratory flow-volume values 9 days postoperatively. The inspiratory values tended to increase slightly over the next half year.