Health Condition 1: C040- Malignant neoplasm of anterior floor of mouth Health Condition 2: C101- Malignant neoplasm of anterior surface of epiglottis Health Condition 3: C113- Malignant neoplasm of anterior wall of nasopharynx Health Condition 4: C131- Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect Health Condition 5: C01- Malignant neoplasm of base of tongue Health Condition 6: C021- Malignant neoplasm of border of tongue Health Condition 7: C104- Malignant neoplasm of branchi
Conditions
Interventions
Intervention1: Prophylactic swallowing therapy for patients receiving radiation therapy with/without chemotherapy: Intervention:
The intervention protocol consists of a combination of swallowing exerc
Sponsors
Ms Janet Jaison Varghese
Eligibility
Inclusion criteria
Inclusion criteria: 1) An existing diagnosis of stage I, II, III or IVA non-metastatic squamous cell carcinoma of the head & neck region. 2) CRT/RT with a curative intent as the expected mode of intervention 3) Karnofsky Performance Status of >70. 4) Intermediate reading and writing proficiency in Kannada/Malayalam. 5) Able to be cognitively, mentally, and legally capable of making independent decisions regarding personal medical care
Exclusion criteria
Exclusion criteria: Exclusion criteria for Intervention Group and Control Group: 1) Patients who are planned for surgical resection of the malignancy. 2) An existing diagnosis of dysphagia unrelated to his/her current diagnosis of cancer 3) Cancer related dysphagia of moderate to higher severity at baseline 4) Metastatic patients, and those receiving treatment with a non-curative intent. 5) Prior treatment for any cancers, including cancers of the head & neck region. 6) Patients with a history of spine surgery or any other neurosurgical procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Swallowing outcome as assessed by Mann Assessment of swallowing abilities- Cancer (MASA-C) Timepoint: o Baseline Assessment o At the end of CRT/RT o 1 month after conclusion of CRT/RT o 3 months after conclusion of CRT/RT o 6 months after conclusion of CRT/RT | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in amplitude and duration of masseter, submental and infrahyoid muscles during voluntary single swallow of 5ml volume of mineral water under sEMG analysisTimepoint: o Baseline Assessment o 1 month after conclusion of CRT/RT ;Change in oral food intake as measured by Functional Oral Intake Scale (FOIS)Timepoint: o Baseline Assessment o At the end of CRT/RT o 1 month after conclusion of CRT/RT o 3 months after conclusion of CRT/RT o 6 months after conclusion of CRT/RT ;Change in QOL, assessed with the â??European Organization of Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ-C30)â?? and its â??Head and Neck Cancer Module (QLQ-H&N35)â??-Kannada and MalayalamTimepoint: o Baseline Assessment o At the end of CRT/RT o 1 month after conclusion of CRT/RT o 3 months after conclusion of CRT/RT o 6 months after conclusion of CRT/RT ;Mouth opening or the maximal inter-incisor opening (MIO) of the mouth, using the Boleyâ??s GaugeTimepoint: o Baseline Assessment o At the end of CRT/RT o 1 month after conclusion of CRT/RT o 3 months after conclusion of CRT/RT o 6 months after conclusion of CRT/RT ;Mucositis Grading using Oral Mucositis Assessment Scale (OMAS)Timepoint: Every week during the course of Radiation therapy with/without chemotherapy | — |
Countries
India
Contacts
Public ContactJanet Jaison Varghese
Manipal College of Health Professions, Manipal Academy of Higher Education
Outcome results
None listed