The Effect of Beta-glucan in Non-Small Cell Lung Cancer

Официальное название

Beta-glucan's Immuno-modulatory Effect on Non-Small Cell Lung Cancer

Обзор

The purpose of this study is to determine how beta-glucan affects the immune system in subjects with non-small cell lung cancer.

Подробное описание

Beta-glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. Imucell WGP is extracted from food-grade baker's yeast, which is permitted for use in food by the U.S. Food and Drug Administration (FDA). Studies in animals have shown that Imucell WGP helps trigger white blood cells to destroy cancer cells. Other animal studies combining Imucell WGP with anti-cancer medications have shown greater tumor regression and tumor-free survival.

Вмешательства

• Пищевая добавка beta-glucan
  AIM 2: regimen to begin after baseline blood draw; AIM 3: regimen to begin after baseline blood draw and to be completed prior to surgery

Первичные конечные точки

• blood specimens will be obtained to examine the ability of beta-glucan to prime neutrophils complement receptor 3 (CR3) and test the cytotoxicity of the primed neutrophils. [Срок оценки: pre-treatment and post-treatment]
• resected lung tissue will be tested to determine macrophage phenotype [Срок оценки: post-treatment]

Критерии участия

AIM 2:

Критерии включения

• suspected or definitive diagnosis of non-small cell lung cancer (NSCLC)
• treatment naive or no treatment within 6 months prior to enrollment
• able to swallow pills
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
• absolute neutrophil count (ANC) at least 1500/microl
• able to understand and willing to sign a written informed consent document

Критерии исключения

• history of hypersensitivity reactions attributed to beta-glucan
• currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy
• presence of an uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

AIM 3:

Критерии включения

• resectable non-small cell lung cancer (NSCLC), as determined by a thoracic surgeon
• treatment naive
• able to swallow pills
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• must be an operative candidate
• absolute neutrophil count (ANC) at least 1500/microl
• able to understand and willing to sign a written informed consent document

Критерии исключения

• history of hypersensitivity reactions attributed to beta-glucan
• currently receiving continuous corticosteroids or other ongoing immunosuppressive therapy
• presence of an uncontrolled intercurrent illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• James Graham Brown Cancer Center — Louisville

Идентификаторы

NCT: NCT00682032 · 08.0041 · BCC-LUN-07-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗