A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy

NCT06706752 | Recruiting

• 1 other identifier: 2052995
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Brief Fatigue Inventory

  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).

  14 days

Study Arms (2)

Treatment Group

EXPERIMENTAL

Dietary Supplement: Shengbai Oral Formula

Placebo Group

PLACEBO COMPARATOR

Other: Inactive Placebo

Interventions

Shengbai Oral Formula DIETARY_SUPPLEMENT

Shengbai Oral Formula contains 11 herbs: Folium Epimedii, Fructus Lycii, Radix Astragali, Caulis Spatholobi, Radix Rubiae, Rhizoma Phragmitis, Fructus Psoraleae, Radix Angelicae Sinensis, Radix Ophiopogonis,, Radix et Rhizoma Glycyrrhizae, Radix Aconiti Lateralis Preparata (Processed). It is taken by mouth three times per day for 14 days.

Treatment Group

Inactive Placebo OTHER

Inactive placebo will be taken by mouth three times per day for 14 days.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Abnormal ALT/AST: \> 2.5 to 3 times normal range
• eGFR \<60
• Platelets \< 75,000
• Hb \<8.0
• ANC \<1000
• 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

Sponsors & Collaborators

• Sutter Health: lead

Study Sites (1)

Sutter Health

Oakland, California, 94609, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Janet Han, BSN, RN

CONTACT

510-204-4405; janet.han@sutterhealth.org

Leila Murray, BSN, RN

CONTACT

510-204-1608; lilly.murray@sutterhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Holistic/Integrative Medicine Physician

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: January 24, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)