Lung Cancer
Conditions
Brief summary
This single arm Phase II trial will investigate the feasibility of dietary flaxseed (FS) supplementation in subjects receiving definitive chemoradiotherapy for non-small cell lung cancer (NSCLC). Subjects will ingest FS for a period of approximately 8 to 9 weeks during the course of radiation treatment. Study participation and surveillance will last approximately 6 months. Subject specimen collection will include: blood, urine, and buccal swabs at 5 time points.
Interventions
DIETARY_SUPPLEMENTFlaxseed
Whole grain flaxseed diet consisting of 40g flaxseed ingested per day
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, ages 18 and older * Current diagnosis of non-small cell lung cancer (NSCLC) including patients who have metastatic disease requiring definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy. * Able to provide written informed consent and comply with all study procedures * Total planned radiation dose to gross disease 60-70 Gy.
Exclusion criteria
* Current diagnosis of disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) * Known hypersensitivity to flaxseed or any of its metabolites, or wheat products * Taking or has taken an investigational drug within 14 days. * Taking or has taken Amifostine or Mucomyst (N-acetylcysteine) within 14 days * Current or prior use of flaxseed, flax-containing products, soybeans, or soy-containing products * Current or prior use (limited to prior 14 days) of dietary supplements such as herbals or botanicals * Prior thoracic and/or mediastinal radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Radiation-Induced Lung Injury | 6 months | Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer. |
| Rates of Grade >3 Radiation Pneumonitis | 6 months | Toxicity and tolerability data of dietary FS administration during chemoradiotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of MIG | 6 months |
| Concentration of MIP-1α | 6 months |
| Concentration of MIP-1ß | 6 months |
| Concentration of RANTES | 6 months |
| Concentration of EGF | 6 months |
| Concentration of FGF-Basic | 6 months |
| Concentration of HGF | 6 months |
| Concentration of VEGF | 6 months |
| Concentration of IL-17 | 6 months |
| Concentration of TNF-α | 6 months |
| Concentration of Eotaxin | 6 months |
| Concentration of G-CSF | 6 months |
| Concentration of GM-CSF | 6 months |
| Concentration of IFN-α | 6 months |
| Concentration of IP-10 | 6 months |
| Concentration of IL-1β | 6 months |
| Concentration of IL-1RA | 6 months |
| Concentration of IL-2 | 6 months |
| Concentration of IL-2R | 6 months |
| Concentration of IL-4 | 6 months |
| Concentration of IL-5 | 6 months |
| Concentration of IL-6 | 6 months |
| Concentration of IL-7 | 6 months |
| Concentration of IL-8 | 6 months |
| Concentration of IL-10 | 6 months |
| Concentration of IL-12 | 6 months |
| Concentration of IL-13 | 6 months |
| Concentration of IL-15 | 6 months |
| Concentration of IFN-γ | 6 months |
| Concentration of MCP-1 | 6 months |
Countries
United States
Outcome results
None listed