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Cohort A for Malnutrition (G-Tube Trial)
N/A
Waitlist Available
Led By Candida Barlow, MSN RN
Research Sponsored by St. John Health System, Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Malnutrition
- Gastrostomy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient loss of speech increase or decrease
Patient loss of swallow function increase or decrease
Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment.
Secondary study objectives
Deglutition
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment5 Interventions
Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. 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 A and B.
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.
Group II: Cohort BExperimental Treatment5 Interventions
Head and Neck Cancer patients receiving Chemotherapy 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 A 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.
Group III: Cohort AExperimental Treatment5 Interventions
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.
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Who is running the clinical trial?
St. John Health System, OklahomaLead Sponsor
2 Previous Clinical Trials
140 Total Patients Enrolled
Candida Barlow, MSN RNPrincipal InvestigatorSt. John Health System
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