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White Paper

1. Executive Summary

Digestive cancers remain one of the most challenging forms of cancer globally, with limited treatment options and high recurrence rates. Wasong (Orostachys japonica), a traditional botanical with demonstrated anticancer properties in preclinical studies, may provide a novel therapeutic avenue. This clinical trial aims to assess the efficacy and safety of Wasong in patients with stage I–III digestive cancers. Over a two-year period, this randomized, double-blind, placebo-controlled study will investigate progression-free survival, overall survival, and quality of life outcomes. The trial is sponsored by Glowasong and will serve as a foundation for future integrative oncology protocols.

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2. Background and Rationale

Digestive cancers, including colorectal, gastric, pancreatic, and esophageal cancers, account for a significant global disease burden. Current treatment strategies often result in severe side effects and limited survival benefits. Wasong (Orostachys japonica) is a succulent plant rich in flavonoids, triterpenes, and polyphenols known for anti-inflammatory, antioxidant, and anticancer effects. Preliminary studies suggest that Wasong may inhibit tumor cell proliferation, induce apoptosis, and enhance immune response. This trial is designed to translate these findings into clinical benefit.

 

3. Objectives

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Primary Objective:

  • Determine the impact of Wasong on progression-free survival in stage I–III digestive cancer patients.

 

Secondary Objectives:

  1. Assess overall survival.​

  2. Evaluate improvements in patient quality of life.

  3. Determine safety and tolerability of Wasong.

  4. Monitor tumor marker response and recurrence rates.

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4. Trial Design

  • Type: Randomized, double-blind, placebo-controlled

  • Duration: 24 months

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  • Phases:

    • Phase I: Safety and dose calibration (3 months)

    • Phase II: Efficacy and comparison with placebo (21 months)

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  • Sample Size: 200 patients

  • Randomization: 1:1 (Wasong vs. placebo)

  • Blinding: Double-blind for participants and investigators

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5. Intervention Details

  • Treatment Group: Daily oral Wasong gel/capsule (standardized dose)

  • Control Group: Matching placebo

  • Standard Care: Allowed per clinical judgment (e.g., surgery, chemotherapy)

  • Duration per Patient: 24 months with monthly follow-up

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6. Inclusion and Exclusion Criteria

Inclusion Criteria:

  • Ages 25–75

  • Diagnosed with stage I–III digestive cancer

  • ECOG performance status 0–2

  • Life expectancy >12 months

  • Informed consent obtained

Exclusion Criteria:

  • Stage IV cancer

  • Prior Wasong use

  • Immunocompromised status

  • Pregnancy or breastfeeding

  • Concurrent participation in another trial

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7. Methodology

  • Recruitment: Hospitals, cancer centers, community outreach

  • Monitoring: Monthly exams, imaging every 3–6 months

  • Data Collection: Bloodwork, imaging, QoL surveys

  • Adherence Tools: Electronic tracking, patient diaries

  • Biomarkers: Optional sampling for mechanistic insights

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8. Endpoints

Primary Endpoint:

  • Progression-Free Survival (PFS)

Secondary Endpoints:

  • Overall Survival (OS)

  • Quality of Life (QoL)

  • Tumor recurrence rate

  • Adverse events (graded via CTCAE v5.0)

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9. Statistical Analysis Plan

  • Kaplan-Meier analysis for survival outcomes

  • Cox proportional hazards modeling

  • Repeated measures ANOVA for QoL

  • Interim analysis at 12 months

  • ITT and per-protocol analyses

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10. Regulatory and Ethical Compliance

  • IRB and ethics board approval

  • Patient informed consent

  • ClinicalTrials.gov registration

  • FDA Botanical IND compliance

  • Oversight by Data and Safety Monitoring Board (DSMB)

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11. Budget Overview

  • Personnel: PI, coordinators, lab staff

  • Wasong sourcing and processing

  • Patient recruitment and compensation

  • Imaging and lab diagnostics

  • Data systems and regulatory support

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12. Timeline

Phase

Activity

Timeline

I

Protocol Development & Approvals

Months 1–3

II

Participant Recruitment

Months 4–9

III

Treatment & Monitoring

Months 4–24

IV

Data Analysis & Reporting

Months 22–24

V

Publication & Dissemination

Month 24+

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13. Team and Collaborators

  • Principal Investigator(s)

  • Research Nurses and Coordinators

  • Partner Hospitals and Labs

  • Botanical Experts and Suppliers (Glowasong Co.)

  • Independent DSMB Members

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14. Potential Impact

This trial may position Wasong as a novel, low-toxicity adjunct or alternative to conventional digestive cancer therapies. If successful, it would justify larger trials, encourage FDA consideration for botanical drug approval, and expand access to plant-based treatments. The findings could also serve integrative oncology programs worldwide.

 

15. References

  • [Include peer-reviewed articles on Wasong's anticancer properties]

  • [WHO and NIH statistics on digestive cancer]

  • [FDA botanical drug development guidelines]

Prepared by: Glowasong Company a Nonprofit
Date: July11, 2025

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