Clinical trial · Interventional
Flaxseed Supplement in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Undergoing Chemotherapy and Radiation Therapy
A Phase I Blinded, Randomized Feasibility Trial of Dietary Flaxseed Administration in Non-Small Cell Lung Cancer Patients Receiving Definitive Thoracic Chemoradiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient enrollment
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Flaxseed may help protect normal cells from the side effects of radiation therapy. PURPOSE: This randomized phase I trial is studying the side effects of flaxseed supplement in treating patients with locally advanced or metastatic non-small cell lung cancer undergoing chemotherapy and radiation therapy.
Conditions
Conditions (2)
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 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flaxseed | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients consume flaxseed muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
- interventionNames
- Dietary Supplement: flaxseed
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients consume placebo muffins once or twice daily beginning on the first day of radiotherapy and continuing for up to 9-10 weeks.
- interventionNames
- Other: placebo
Primary outcomes (2)
- measure
- Feasibility of dietary flaxseed (FS) supplementation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of non-small cell lung cancer * Locally advanced or metastatic disease * Requires definitive thoracic and mediastinal radiotherapy with concurrent chemotherapy * Total planned radiation dose to gross disease 60-80 Gy PATIENT CHARACTERISTICS: * No diagnosis of disease of the gastrointestinal (GI) system, liver, or kidneys that could result in altered metabolism or excretion of the study medication (e.g., history of major GI tract surgery, gastrectomy, gastrostomy, or bowel resection) * No history of chronic GI disorders (e.g., ulcerative colitis, regional enteritis, or GI bleeding) * No known hypersensitivity to flaxseed or any of its metabolites or to wheat products PRIOR CONCURRENT THERAPY: * See Disease Characteristics * See Patient Characteristics * More than 14 days since prior and no concurrent investigational drugs * More than 14 days since prior and no concurrent amifostine or Mucomyst (N-acetylcysteine) * No prior thoracic radiotherapy * No prior or other concurrent flaxseed, flax-containing products, soybeans, or soy-containing products * No other concurrent dietary supplements, such as herbals or botanicals * Vitamins or multivitamins, including calcium and vitamin D, are allowed
References
Publications (0)
Data not yet available