Clinical trial · Interventional
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
NCT02775721CI-TRIAL-00032522G-TubeunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for head and neck cancer. Inadequate dietary intake is multi factorial, with patients experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related to Head and Neck cancer treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrostomy | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nursing Education related to Gastrostomy Tube Care | Other | — | UNRESOLVED |
| Nutritional Therapy Education and Evaluation | Other | — | UNRESOLVED |
| Quality of Life Questionnaire C30 version 3 | Other | — | UNRESOLVED |
| Quality of Life Questionnaire EORTC QLO - H&N35 | Other | — | UNRESOLVED |
| Speech Therapy Education and Evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Cohort A
- description
- Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C. Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process. Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist. Nutritional therapy education and evaluation is assessed per the attending dietitian. The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H\&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
- interventionNames
- Other: Nursing Education related to Gastrostomy Tube Care
- Other: Speech Therapy Education and Evaluation
- Other: Nutritional Therapy Education and Evaluation
- Other: Quality of Life Questionnaire C30 version 3
- Other: Quality of Life Questionnaire EORTC QLO - H&N35
- type
- OTHER
- label
- Cohort B
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older * Head and Neck cancer diagnosis * Esophageal cancer diagnosis * Receiving chemotherapy and/or radiation therapy * Gastrostomy Tube placed within the last 30days or scheduled to have a gastrostomy tube placed within the next 30 days Exclusion Criteria: * Not eligible for chemotherapy and/or radiation therapy * Unwilling or unable to sign informed consent * Any cognitive or mental deficits that would prevent patient from completing questionnaires or understanding educational interventions * Current pre-existing Gastrostomy tube complications if a current Gastrostomy tube is in place prior to informed consent (i.e., skin breakdown, tube breakdown, other tube complications). * No Gastrostomy tube placement * Non-English Speaking
References
Publications (0)
Data not yet available
No reference posted for this study.