Study Stopped
Lack of participant recruitment.
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer
1 other identifier
interventional
7
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2009
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 25, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedOctober 14, 2015
October 1, 2015
2.9 years
September 25, 2015
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Esophagitis Grading
Eight (8) weeks
Treatment Break Measurement
Eight (8) weeks
Study Arms (1)
Whole Food Intervention Treated
EXPERIMENTALGroup of participants given the experimental WFI along with standard cancer treatment.
Interventions
A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Oregon Clinic, Providence Portland Cancer Center
Portland, Oregon, 97213, United States
Integrative Medicine Program, Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miles H Hassell, MD
Providence Health & Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2015
First Posted
October 14, 2015
Study Start
October 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
October 14, 2015
Record last verified: 2015-10