NCT06706752RecruitingNot Applicable
A Randomized, Blinded, Placebo-controlled Trial of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Patients With Cancer Undergoing Chemotherapy
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sutter Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Brief Fatigue Inventory
Study Overview
Brief Summary
The goal of this clinical trial is to assess whether Shengbai Oral Formula is a viable option for treatment of fatigue, pain, and neutropenia in patients undergoing their third cycle of chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-80 years of age
- •A cancer diagnosis and scheduled to undergo at least three rounds of chemotherapy for curative or palliative intent
- •Chemotherapy is given at a minimum of every 2 weeks
- •At least 30 days past radiation therapy
- •Nonpregnant and use of method of contraception per the treating clinician standard of care
- •Life expectancy > 3 months
- •Stable on all herbal or complementary therapeutics for the past 30 days and agree to not include new complementary therapeutics until after study completion
- •Baseline ECOG ≤ 2
- •In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study including all scheduled evaluations and required tests
Exclusion Criteria
- •Abnormal ALT/AST: > 2.5 to 3 times normal range
- •Platelets < 75,000
- •Documentation of a bone marrow transplant
- •Documentation of brain metastases, diagnosis with other cancer, except skin cancer history with basal cell carcinoma, squamous carcinoma
- •Documentation of current seizure disorder
- •Documentation of new cardiac arrhythmias and myocardial infarction
- •Any active bacterial or viral infection, pneumonia, sepsis, active gastric ulcer, gastritis, nonhealing wound, intractable nausea or vomiting, diarrhea, bleeding disorder
- •Hyperthyroidism, connective tissue disease including systemic lupus erythematous, rheumatoid arthritis
- •Documentation of a current drug abuse disorder
- •Current participation in other clinical trial
Arms & Interventions
Treatment Group
Experimental
Intervention: Shengbai Oral Formula (Dietary Supplement)
Placebo Group
Placebo Comparator
Intervention: Inactive Placebo (Other)
Outcomes
Primary Outcomes
Brief Fatigue Inventory
Time Frame: 14 days
The Brief Fatigue Inventory (BFI) is used to assess the severity and impact of fatigue, including cancer-related fatigue. Fatigue scores on the BFI are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).
Secondary Outcomes
No secondary outcomes reported
Investigators
Amy Matecki
Principal Investigator and Holistic/Integrative Medicine Physician
Sutter Health
Study Sites (1)
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