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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

Randomised Trial comparing efficacy of Prophylactic versus Reactive Enteral Tube Insertion for Enteral Nutrition in Patients with Locally Advanced Head and Neck Carcinoma Treated with (Chemo)radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021264
Enrollment
580
Registered
2019-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Prophylactic Enteral Tube Insertion: PEG/NGT insertion prior to treatment Control Intervention1: Reactive Enteral Tube insertion: PEG/NGT insertion during treatment

Sponsors

Tata Research Administration Council
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The impact of prophylactic enteral tube placement compared to reactive tube (P-PEG/NGT vs RPEG/ NGT) on the risk of significant weight loss (10% of baseline body weight)Timepoint: At 6 months after treatment—

Secondary

MeasureTime frame
1. The relative variation of weight changes over a 24-month period 2. Change in mid upper arm circumference (MUAC) 3. Changes in biochemical parameters over time 4. The duration of tube use 5. Tube dependence (defined as duration of tube use more than 12 months post-treatment) 6. Compliance to therapy and radiotherapy treatment break 7. The swallowing functions 8. Quality of life 9. The local control and overall survivalTimepoint: After 24 months—

Countries

India

Contacts

Public ContactDr Sarbani Ghosh Laskar

Tata Memorial Centre

sarbanilaskar@gmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026