Zerumbone, a compound extracted from bitter ginger (Zingiber zerumbet), for patients with solid tumors with no treatment options: A pilot clinical study

Bitter ginger (Zingiber zerumbet) for patients with advanced cancer: A pilot clinical study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19153068

Enrollment

Registered

2023-07-06

Start date

2018-10-01

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced solid tumors without any more specific anti-neoplastic treatment options Cancer

Interventions

In this pilot study, patients were recruited from clinical oncology outpatient clinics in São Bernardo do Campo and Santo André, São Paulo, Brazil. Zingiber zerumbet (ZZ) rhizomes were collected from

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years old, regardless of sex, 2. Previously treated advanced solid tumors with no treatment options according to the attending physician 3. Life expectancy of at least two months 4. Creatine levels up to twice the upper limit of normal (ULN) 5. Serum glutamic oxaloacetic transaminase (SGOT) and glutamic pyruvic transaminase (GPT) levels up to twice the ULN (for patients with liver disease, levels up to 2.5 times the ULN are considered), and direct bilirubin (DB) levels up to 1.5 times the ULN (for patients with liver disease, levels up to 2.5 times the ULN are considered).

Exclusion criteria

Exclusion criteria: 1. Objections to the procedures in the study or the terms described in the informed consent form 2. Pregnancy and/or lactation (female patients of childbearing age had to present a negative quantitative blood human chorionic gonadotropin [HCG] test) 3. Current treatment with chemotherapeutic or other antineoplastic agents for antitumor therapy 4. Analgesic radiotherapy and zoledronic acid administration for bone metastases were accepted as supportive therapies 5. Patients with a diagnosis of renal failure or severe liver disease 6. A history of hypersensitivity to formula components 7. Emotional disorders that could compromise data collection

Design outcomes

Primary

Measure	Time frame
Quality of life measured using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) at T=0 (before starting the medication), Week 4 and Week 8	—

Secondary

Measure	Time frame
Fatigue measured using Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) scale at T=0 (before starting the medication), Week 4 and Week 8	—

Countries

Brazil

Contacts

Public ContactAuro del Giglio

aurodelgiglio@gmail.com+55 11996364237

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026