Not provided
Not provided
Not provided
Not provided
Not provided
Lack of participant recruitment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Food Intervention Treated | Experimental | Group of participants given the experimental WFI along with standard cancer treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Food Intervention | Dietary Supplement | A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Esophagitis Grading | Esophagitis grade was calculated using established criteria. | Eight (8) weeks |
| Treatment Break Measurement | To determine whether Whole Food Intervention will reduce the incidence of treatment breaks from ≥19% to ≤10%. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Miles H Hassell, MD | Providence Health & Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Oregon Clinic, Providence Portland Cancer Center | Portland | Oregon | 97213 | United States | ||
| Integrative Medicine Program, Providence St. Vincent Medical Center |
Not provided
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Eight (8) weeks |
| Portland |
| Oregon |
| 97225 |
| United States |