A research study to know the effect of inserting feeding tube to maintain nutrition before start of radiotherapy over inserting feeding tube during radiotherapy to prevent malnutrition in head and neck patients receiving radio/chemoradiotherapy
Not Applicable
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2019/09/021264
- Lead Sponsor
- Tata Research Administration Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with
1. newly diagnosed non-metastatic T3 or T4 oropharyngeal, laryngeal and hypopharyngeal
cancer with any N stage
2. Planned for definitive radiotherapy or chemo-radiotherapy.
3. Karnofsky Performance Scale > 70
4. Written informed consent for the study participation including intervention and follow-up
Exclusion Criteria
1. Grade >=3 dysphagia ( CTCAE v4) or aspiration
2. Previous head neck surgery affecting swallowing
3. Not suitable for definitive treatment
4. Prior history of malignancy or radiation
5. Previous treatment with neoadjuvant chemotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The impact of prophylactic enteral tube placement compared to reactive tube (P-PEG/NGT vs RPEG/ <br/ ><br>NGT) on the risk of significant weight loss (10% of baseline body weight)Timepoint: At 6 months after treatment
- Secondary Outcome Measures
Name Time Method 1. The relative variation of weight changes over a 24-month period <br/ ><br>2. Change in mid upper arm circumference (MUAC) <br/ ><br>3. Changes in biochemical parameters over time <br/ ><br>4. The duration of tube use <br/ ><br>5. Tube dependence (defined as duration of tube use more than 12 months post-treatment) <br/ ><br>6. Compliance to therapy and radiotherapy treatment break <br/ ><br>7. The swallowing functions <br/ ><br>8. Quality of life <br/ ><br>9. The local control and overall survivalTimepoint: After 24 months