Health Condition 1: C32- Malignant neoplasm of larynx Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Augmented Supportive Care: 1) Speech and Swallowing Assessment: Pre-treatment and then at least once in two weeks while on chemoradiation and until 2 weeks post treatment.
2) Specialist
Sponsors
National Institutes of Health USA
University of Pittsburgh
Eligibility
Inclusion criteria
Inclusion criteria: 1) Squamous Cancer of oropharynx, larynx or hypopharynx 2) Stage III-IV; 3) Planned for curative intent treatment with radiation & concomitant platinum based chemotherapy; 4) Creatinine clearance (more than or equal to 50 mL/min prior to starting chemotherapy) 5) WHO performance status 0 or 1
Exclusion criteria
Exclusion criteria: 1) Documented evidence of pre-existing swallowing dysfunction (not related to HNC); 2) Previous radiotherapy to the head and neck region; 3) Major head and neck surgery (excluding biopsies/tonsillectomy); 4) Tracheostomy placement before the start of chemoradiation; 5) Previous or concurrent illness, which in the investigatorâ??s opinion would interfere with completion of therapy, trial assessments or follow-up.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1) Weight loss 2) Enteral feeding tube dependenceTimepoint: At completion of treatment and at 3 months of treatment completion. | — |
Primary
| Measure | Time frame |
|---|---|
| 1) Symptomatic aspiration pneumonia (i.e., clinical or radiological evidence of pneumonia; and symptoms of aspiration â?? e.g. cough on swallow or documented silent aspiration on clinical swallowing tests/FEES); 2) Death due to any cause during or within 3 months of completion of radical intent chemoradiation.Timepoint: Three months of completion of Radiotherapy and concomitant chemotherapy | — |
Countries
India
Contacts
Public ContactDr Indranil Mallick
Tata Medical Center
Outcome results
None listed