Clinical trial · Interventional
Saw Palmetto: Symptom Management for Men During Radiation Therapy
Saw Palmetto Use During Radiation Therapy for Symptom Management Among Prostate Cancer Patients
NCT01585246CI-TRIAL-00040903completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to test whether Saw Palmetto, is useful in preventing or reducing the side effects for men undergoing radiation therapy for prostate cancer. Urinary symptoms will be recorded each week, as well as assessment of quality of life through: 1) Physical Well-Being 2) Social/Family Well-being 3) Emotional Well-Being, and 4) Functional Well-Being.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Saw Palmetto | Drug | — | UNRESOLVED |
| soybean oil soft gel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Phase 1: The dose finding phase (DFP)
- description
- Patients received Saw Palmetto Soft Gel capsules in 320mg or 640mg or 960mg to determine the maximum therapeutic dose
- interventionNames
- Drug: Saw Palmetto
- type
- ACTIVE_COMPARATOR
- label
- Phase 2: RCT phase- Saw Palmetto
- description
- Patients received the predetermine the maximum therapeutic dose of Saw Palmetto Soft Gel capsules in phase 1, which is 960mg.
- interventionNames
- Drug: Saw Palmetto
- type
- PLACEBO_COMPARATOR
- label
- Phase 2: RCT phase- Placebo
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age 21 years or older * Adenocarcinoma of the prostate * Serum Prostate Specific Antigent (PSA) ≤ 40ng/ml * Combined Gleason Score ≤ 8 * Karnofsky level of performance of \> 70% * Consented to undergo definitive Radiation Therapy Exclusion Criteria: * Stage T4 or M1 * Patient using own supply of Saw Palmetto or any other supplement containing the following herbs: Pygeum (African Plum), Urtica Dioica (Stinging nettle), Cucurbita peponis (pumpkin seed), PC-SPES (combination of 8 herbs), Beta-sitsterol (plant sterols) or Cernilton (rye grass pollen). * Prior pelvic radiation therapy * Abnormality in liver and kidney function as evidenced by greater than twice the normal values of Blood Urea Nitrogen (BUN), serum creatine, serum transaminases, and alkaline phosphatase. * Uncontrolled hypertension despite use of antihypertensive medication * Presence of major psychiatric or medical illness (e.g., major cardiovascular events within the previous 12 months)
References
Publications (0)
Data not yet available
No reference posted for this study.