Assessment of Vocal Cord Mobility in Laryngopharyngeal Cancers with Fixed Vocal Cord After Definitive Chemoradiation A Prospective Hospital Based Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- RESTORATION OF VOCAL CORD MOBILITY AFTER DEFINITIVE CHEMO RADIATION IN LARYNGOPHARYNGEAL CANCERS WITH PREVIOUSLY FIXED VOCAL CORDS ASSESSED USING DIRECT LARYNGOSCOPY OR ENDOSCOPY AT SPECIFIC TIME INTERVALS. COMPLETE ABDUCTION OF VOCAL CORDS DEFINED AS SEPARATION OF ATLEAST 1 CM FROM MIDLINE WILL BE CONSIDERED AS INDICATOR RESTORED MOBILITY.
研究概览
简要总结
This study is a prospective, hospital-based observational research project conducted at Dr. Bhubaneswar. Borooah Cancer Institute, Guwahati, over a duration of one year. Its primary aim is to evaluate the restoration of vocal cord mobility in patients with laryngopharyngeal cancers presenting with fixed vocal cords following definitive chemoradiation. The study also focuses on assessing treatment-induced toxicities and the impact on patients’ voice-related quality of life using the Voice Handicap Index (VHI).
The research adopts a non-randomized, non-interventional design with a planned sample size of 118 patients. Eligible participants are aged between 18–70 years, have histologically proven laryngopharyngeal cancer with vocal cord fixity confirmed through laryngoscopy or endoscopy, and meet specific health and consent criteria. The treatment protocol includes standard chemoradiation comprising a total radiation dose of 66–70 Gy alongside weekly cisplatin chemotherapy.
Patients undergo thorough pre-treatment evaluation and weekly monitoring during the treatment period to minimize interruptions and assess radiation-induced toxicities. Post-treatment assessments are conducted at 6 weeks and 3 months, using laryngoscopy or endoscopy to measure vocal cord mobility restoration. Restoration is defined as complete vocal cord abduction, with at least 1 cm separation from the midline.
In addition to its primary goal, the study evaluates radiotherapy toxicities based on CTCAE criteria and assesses changes in patients’ voice quality using VHI questionnaires. The findings will contribute to understanding the functional outcomes of organ preservation approaches and the prognostic significance of vocal cord mobility post-chemoradiation. The results are expected to provide insights for improving treatment protocols and patient quality of life.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically proven laryngopharyngeal cancers with unilateral or bilateral fixed vocal cords confirmed with endoscopy or laryngoscopy, patients giving written informed consent to participate in the study,patients with ECOG PS 0 to 2,baseline CBC, LFT and RFT are within normal limits, at least 3 months of follow up after completion of treatment.
排除标准
- •Patients with vocal cord mobility impairment due to causes other than laryngopharyngeal cancers and its treatment (eg: congenital anomalies, trauma, neurological disorders), patients with laryngopharyngeal cancers with extra laryngeal extension or cartilage erosion,patient unwilling or unable to participate in follow-up assessments,patients with other concurrent head and neck cancers,patients with uncontrolled cardiovascular, pulmonary or metabolic renal disease,patient with metastatic laryngopharyngeal cancers with fixed vocal cords.
结局指标
主要结局
RESTORATION OF VOCAL CORD MOBILITY AFTER DEFINITIVE CHEMO RADIATION IN LARYNGOPHARYNGEAL CANCERS WITH PREVIOUSLY FIXED VOCAL CORDS ASSESSED USING DIRECT LARYNGOSCOPY OR ENDOSCOPY AT SPECIFIC TIME INTERVALS. COMPLETE ABDUCTION OF VOCAL CORDS DEFINED AS SEPARATION OF ATLEAST 1 CM FROM MIDLINE WILL BE CONSIDERED AS INDICATOR RESTORED MOBILITY.
时间窗: At 6 weeks post definitive chemoradiation and at 3 months post definitive chemoradiation
次要结局
- To assess for acute radiotherapy induced toxicities,to assess the voice related quality of life using Voice Handicap Index (VHI) in these group of patients.
研究者
Dr Apurba Kumar Kalita
Dr Bhubaneswar Borooah Cancer Institute