Clinical trial · Interventional
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
Phase I-II Trial of Genistein in Subjects Receiving Palliative External Beam Radiation Therapy for Osseous Metastases: A Study of Palliation of Symptoms and Quality of Life
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patient accrual.
Summary
Brief summary (as posted)
RATIONALE: Genistein may increase the effectiveness of radiation therapy in treating pain caused by bone metastases. PURPOSE: This phase I/II trial is studying the side effects of genistein and to see how well it works in treating patients undergoing external-beam radiation therapy for pain caused by bone metastases.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| genistein | Dietary Supplement | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Genistein
- description
- Patients treated with Genistein who are going to undergo palliative radiation treatments for painful boney metastases.
- interventionNames
- Dietary Supplement: genistein
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Safety
- timeFrame
- At completion of first 6 patients
- description
- Frequency of severe (grade 3) toxicities
Secondary outcomes (3)
- measure
- Time to pain relief, duration of pain relief, and degree of pain relief
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed malignant solid tumor, including any of the following:
* Breast cancer
* Lung cancer
* Kidney cancer
* Melanoma
* Prostate cancer
* Radiographic evidence\* of bone metastasis within the past 8 weeks NOTE: \*Acceptable studies include plain radiograph, radionuclide bone scan, CT scan, and MRI
* Has pain that appears to be related to the radiographically documented metastasis, in the opinion of the treating physician, AND a decision has been made by the responsible clinician that a course of palliative external beam radiotherapy is appropriate treatment
* "Worst pain score" of \> 5 on a scale of 10 as scored on the pain assessment questionnaire (BPI) (question #3: 0 = no pain; 10 = worst possible pain) OR taking narcotic medications with an oral morphine equivalent dose of \> 60 mg/day
* No painful metastases to the skull, hands, or feet
* Eligible treatment sites include any of following:
* Weight-bearing sites:
* Pelvis (excluding pubis)
* Femur
* Sacrum and/or sacroiliac joints
* Tibia
* Non-weight-bearing sites:
* Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies
* Lumbosacral spine
* Up to 3 consecutive ribs
* Humerus
* Fibula
* Radius ± ulna
* Clavicle
* Sternum
* Scapula
* Pubis
* If multiple osseous sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur, or tibia
* Treatment of multiple osseous sites allowed only if those sites can be included in ≤ 3 treatment sites
* Patients with painful metastases that are contiguous but do not fit into the definition of a site listed above are eligible but are considered to have 2 treatment sites
* No vertebral metastases with clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
* No primary hematologic malignancies (e.g., lymphoma)
* Hormone receptor status (for patients with breast cancer):
* Estrogen receptor-negative tumor
* Menopausal status not specified
* Karnofsky performance status 40-100%
* Life expectancy ≥ 3 months
* ALT normal
* Bilirubin normal
* Serum creatinine normal (≤ 1.8 mg/dL for males and ≤ 1.5 mg/dL for females)
* Free T4 and thyroid-stimulating hormone normal
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pathologic fracture or impending fracture of the treatment site
* No history of primary hyperparathyroidism
* No malabsorptive disease or chronic diarrhea
* No history of sarcoidosis or tuberculosis
Exclusion Criteria:
* Less than 30 days since prior systemic radioisotopes for pain, including Strontium-90 (\^90Sr) or Samarium (\^153Sm)
* Less than 30 days since prior antibiotics
* Less than 30 days since prior initiation of systemic therapy (e.g., hormonal therapy, chemotherapy, or immunotherapy)
* Less than 90 days since prior intravenous bisphosphonate therapy
* Concurrent oral bisphosphonates allowed
* Prior radiotherapy or palliative surgery to the painful sites
* Concurrent surgical fixation of the bone
* Concurrent treatment to the skull, hands, or feetReferences
Publications (0)
Data not yet available