Zerumbone, a compound extracted from bitter ginger (Zingiber zerumbet), for patients with solid tumors with no treatment options: A pilot clinical study
| ISRCTN | ISRCTN19153068 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19153068 |
- Submission date
- 03/07/2023
- Registration date
- 06/07/2023
- Last edited
- 08/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This research study aims to explore the potential benefits of using bitter ginger, specifically a natural compound called zerumbone found in bitter ginger plants (Zingiber zerumbet), in cancer patients who have limited treatment options. Bitter ginger has been found to possess several properties, such as anti-inflammatory, antioxidant, and analgesic effects. The study aims to assess whether bitter ginger can improve the quality of life and symptom control in these patients.
Who can participate?
Adult patients over the age of 18 years with advanced solid tumors who have exhausted their treatment options are eligible to participate in this study. The study included both male and female patients with various types of cancers.
What does the study involve?
This pilot study was conducted at a single center and involved a total of 35 patients. Participants were given 400 mg of zerumbone, derived from bitter ginger, twice a day for a duration of eight weeks. The patients visited the clinic for three appointments during the study period, where they underwent clinical examinations, and blood tests, and completed specific questionnaires to assess their quality of life, anxiety, depression, fatigue, and sleep quality. Adverse events were also monitored.
What are the possible benefits and risks of participating?
The study is expected to show promising results in improving the quality of life of patients, particularly in the emotional, social, and activity dimensions. Patients may experience improvements in anxiety, depression, and fatigue. Bitter ginger is generally well-tolerated, with only a few mild side effects expected. However, it is important to note that this is a pilot study with a small number of participants and further research with a larger sample size and a control group is needed to confirm these preliminary findings.
Where is the study run from?
The study was conducted at the clinical oncology outpatient clinics of Anchieta Hospital in São Bernardo do Campo and Mario Covas State Hospital in Santo André, both in São Paulo, Brazil. It was affiliated with the ABC Foundation School of Medicine.
When did the study start and how long is it expected to run for?
June 2018 to February 2023
Who is funding the study?
The study was funded through a partnership between the ABC School of Medicine, the National Institute for Research in the Amazon (Instituto Nacional de Pesquisas da Amazônia - INPA), and the Biozer Laboratory.
Who is the main contact?
Auro del Giglio MD FACP, aurodelgiglio@gmail.com
Contact information
Principal Investigator
Rua Tupi 579
São Paulo
01233-001
Brazil
 ORCID ID |
0000-0002-2009-824X |
|---|---|
| Phone | +55 11996364237 |
| aurodelgiglio@gmail.com |
Scientific
Rua Tupi 579
São Paulo
01233-001
Brazil
| Phone | +55 11996364237 |
|---|---|
| aurodelgiglio@gmail.com |
Public
Rua Tupi 579
São Paulo
01233-001
Brazil
| Phone | +55 11996364237 |
|---|---|
| aurodelgiglio@gmail.com |
Study information
| Study design | Phase II pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Home, Hospice, Hospital |
| Study type | Quality of life, Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request participant information sheet |
| Scientific title | Bitter ginger (Zingiber zerumbet) for patients with advanced cancer: A pilot clinical study |
| Study objectives | Zerumbone is a natural compound found in bitter ginger plants (Zingiber zerumbet) that shows antiproliferative, antioxidant, anti-inflammatory, and analgesic properties. This study aims to investigate the role of zerumbone in improving the quality of life and symptom control in cancer patients with no treatment options |
| Ethics approval(s) |
Approved 20/08/2018, ABC Foundation School of Medicine (Faculdade de Medicina da Fundação ABC; FMABC) (Avenida Príncipe de Gales 821, Santo André, 09060-650, Brazil; +55114993-5453; cep@fmabc.br), ref: 93459418.1.0000.0082 |
| Health condition(s) or problem(s) studied | Patients with advanced solid tumors without any more specific anti-neoplastic treatment options |
| Intervention | 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 Manaus, Amazonas, Brazil, and processed to obtain crude and hydroalcoholic extracts. The extracts were analyzed using thin-layer chromatography (TLC) and high-performance liquid chromatography (HPLC) to identify their components. The Zingiber zerumbet rhizome extract was encapsulated in 400 mg gelatin capsules and given to participants to be administered twice a day for eight weeks. Adherence to the treatment was monitored by evaluating the returning medication packages. The protocol involved three visits: the first visit (T = 0) before initiating the treatment, followed by two other visits every four weeks until week eight of treatment. At each visit, the patients underwent anamnesis, clinical examination, blood collection, and specific questionnaire assessments. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Bitter ginger (Zingiber zerumbet) |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2018 |
| Completion date | 01/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 35 |
| Total final enrolment | 16 |
| Key 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). |
| Key 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 |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 01/11/2022 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Santo Andre
09060-650
Brazil
Sponsor information
Industry
Av. Rodrigo Otávio
1910 - Galpão 32 - Crespo
Manaus
69073-177
Brazil
| Phone | +55 92 992468759 |
|---|---|
| atendimento@simbiozeamazonica.com | |
| Website | https://simbiozeamazonica.com/us/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Auro del Giglio, aurodelgiglio@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/01/2024 | 08/03/2024 | Yes | No |
Editorial Notes
08/03/2024: Publication reference added.
05/07/2023: Trial's existence confirmed by the Research Ethics Committee ABC Faculty of Medicine (Brazil).
