Clinical trial · Interventional
Dietary Flaxseed in NSCLC
Phase II Trial of Flaxseed to Prevent Pneumonopathy After Chemoradiation for Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of patient compliance
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flaxseed | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dietary Supplement: Flaxseed
- interventionNames
- Dietary Supplement: Flaxseed
Primary outcomes (2)
- measure
- Rate of Radiation-Induced Lung Injury
- timeFrame
- 6 months
- description
- Rate of RILI after flaxseed administration in a population of patients receiving definitive chemoradiotherapy for lung cancer.
- measure
- Rates of Grade >3 Radiation Pneumonitis
- timeFrame
- 6 months
- description
- Toxicity and tolerability data of dietary FS administration during chemoradiotherapy
Secondary outcomes (30)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLim TL, Pietrofesa RA, Arguiri E, Koumenis C, Feigenberg S, Simone CB 2nd, Rengan R, Cengel K, Levin WP, Christofidou-Solomidou M, Berman AT. Phase II Trial of Flaxseed to Prevent Acute Complications After Chemoradiation for Lung Cancer. J Altern Complement Med. 2021 Oct;27(10):824-831. doi: 10.1089/acm.2020.0542. Epub 2021 Jun 23. PMID 34161146