Esophagitis Clinical Trial
Official title:
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer With Radiation With or Without Chemotherapy
Verified date | October 2015 |
Source | Providence Health & Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study will evaluate whether a Whole Food Intervention reduces the frequency or severity
of esophagitis in patients receiving treatment for non-small cell lung cancer.
The Whole Food Intervention consists of yogurt, butter, honey, vanilla, and glutamine with 3
portioning cups, equal to approximately 12 ounces, taken daily before starting radiation
therapy.
Status | Terminated |
Enrollment | 7 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histopathologically confirmed diagnosis of thoracic carcinoma - Scheduled to undergo continuous daily course of radiation therapy with or without chemotherapy - No other serious concurrent medical illness as determined by the Principle Investigator - Absolute neutrophil count = 500/mm3 - Platelet count = 50,000/mm3 - No history of insulin-dependent diabetes mellitus - No prior hypersensitivity reaction to compound components Exclusion Criteria: - Dislike of the available forms of the WFI - Allergy or food intolerance relevant to the ingredients - Lack of access to refrigerated storage for the WFI - Inability or unwillingness to participate twice a week - Inability to swallow - Undergoing treatment for HIV with HIV medications - Ongoing alcohol and/or drug abuse |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Integrative Medicine Program, Providence St. Vincent Medical Center | Portland | Oregon |
United States | The Oregon Clinic, Providence Portland Cancer Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Providence Health & Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of Tolerability | Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants. | Eight (8) weeks | No |
Secondary | Esophagitis Grading | Esophagitis grade was calculated using established criteria. | Eight (8) weeks | No |
Secondary | Treatment Break Measurement | To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from =19% to =10%. | Eight (8) weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00284908 -
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00272818 -
Study to Identify Non-Invasive Markers of Gastrointestinal Allergy
|
||
Recruiting |
NCT05326113 -
The Effect of Physiotherapy on Post POEM Reflux
|
N/A | |
Recruiting |
NCT01696734 -
Domperidone in Treating Patients With Gastrointestinal Disorders
|
Phase 3 | |
Completed |
NCT00123630 -
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
|
Phase 2 | |
Completed |
NCT00256529 -
Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
|
N/A | |
Completed |
NCT00081315 -
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00471094 -
Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
|
Phase 2 | |
Completed |
NCT00579410 -
Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule
|
N/A | |
Recruiting |
NCT05109819 -
Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression.
|
N/A | |
Withdrawn |
NCT01824199 -
CYP2C19 Genotype Predictor of Gastric Acid Suppression
|
Early Phase 1 | |
Completed |
NCT01556919 -
Esophageal Monitoring Device for Assessing Mucosal Impedance
|
||
Active, not recruiting |
NCT03835663 -
The Bacterial Composition of the Stomach in Reflux Disease
|
||
Completed |
NCT00195208 -
Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis
|
Phase 3 | |
Completed |
NCT00175045 -
Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis
|
Phase 2 | |
Completed |
NCT05129670 -
Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum
|
N/A | |
Recruiting |
NCT05004155 -
Twenty Four Hour Ambulatory pH & Impedance Testing: Normative Data for Indian Population
|
||
Completed |
NCT03228147 -
Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment
|
N/A | |
Completed |
NCT01322633 -
Risk of Cancer Among Pantoprazole Users
|
N/A | |
Completed |
NCT00133770 -
Intravenous (IV) Pantoprazole in Erosive Esophagitis
|
Phase 4 |