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The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer

Primary Purpose

Esophagitis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Whole Food Intervention
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagitis focused on measuring L-Glutamine, chemotherapy, radiotherapy, therapeutic toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Oregon Clinic, Providence Portland Cancer Center
  • Integrative Medicine Program, Providence St. Vincent Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole Food Intervention Treated

Arm Description

Group of participants given the experimental WFI along with standard cancer treatment.

Outcomes

Primary Outcome Measures

Measurement of Tolerability
Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.

Secondary Outcome Measures

Esophagitis Grading
Esophagitis grade was calculated using established criteria.
Treatment Break Measurement
To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from ≥19% to ≤10%.

Full Information

First Posted
September 25, 2015
Last Updated
October 9, 2015
Sponsor
Providence Health & Services
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1. Study Identification

Unique Protocol Identification Number
NCT02575391
Brief Title
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer
Official Title
The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer With Radiation With or Without Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of participant recruitment.
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The proposal is a one center, open label, randomized pilot study to evaluate the safety, tolerability and compliance of a Whole Food Intervention with Standard of Care for patients with non-small cell lung cancer. The primary objectives are: To determine whether patients will use a Whole Food Intervention 4-6 times daily, and To determine whether the Whole Food Intervention will reduce the incidence of grade 2 or greater esophagitis from 75% historically seen to 25% . To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from >19% to < 10% (see section 9 for comments) This Whole Food Intervention will be taken by mouth before the start of radiation therapy, with or without chemotherapy and for the entire treatment therapy. Esophagitis-related pain and reduction of oral intake will be quantified by using validated assessment tools. Weight loss or gain, diarrhea, constipation or no change in bowel function and the use of conventional medication for radiation-induced esophagitis will be recorded. Chart review and patient questionnaires will be used to establish whether a treatment break or dose reduction for radiation of chemotherapy was required due to radiation esophagitis-related symptoms. Complete Chemistry Profile and Complete Blood Count will be extracted from the patients' medical oncologist's or radiation oncologist's records. The patient will continue to use standard esophagitis therapies if desired as prescribed by the treating oncology physician. 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. A questionnaire will be used to record symptoms and doses taken. The patient will continue to use standard esophagitis therapies as prescribed by the treating oncology physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagitis
Keywords
L-Glutamine, chemotherapy, radiotherapy, therapeutic toxicity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole Food Intervention Treated
Arm Type
Experimental
Arm Description
Group of participants given the experimental WFI along with standard cancer treatment.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole Food Intervention
Intervention Description
A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.
Primary Outcome Measure Information:
Title
Measurement of Tolerability
Description
Estimated portion consumption on a daily basis was obtained to determine if the WFI could be tolerated by participants.
Time Frame
Eight (8) weeks
Secondary Outcome Measure Information:
Title
Esophagitis Grading
Description
Esophagitis grade was calculated using established criteria.
Time Frame
Eight (8) weeks
Title
Treatment Break Measurement
Description
To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from ≥19% to ≤10%.
Time Frame
Eight (8) weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miles H Hassell, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Oregon Clinic, Providence Portland Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Integrative Medicine Program, Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer

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