The effect of moringa oleifera leaf extract on the inflammation status of breast cancer patients receiving hormonal therapy
| ISRCTN | ISRCTN11510869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11510869 |
- Submission date
- 30/11/2022
- Registration date
- 01/12/2022
- Last edited
- 19/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
In postmenopausal women who are positive for hormone receptors, an Aromatase Inhibitor (AI) to lower estrogen levels by stopping an enzyme in fat tissue (called aromatase) from changing other hormones into estrogen. Significant joint and muscular problems are frequently complained about and linked as side effects of AI therapy. The hands, wrists, and knees are the most commonly involved region in this illness also known as Aromatase Inhibitor - Associated Musculoskeletal Syndrome (AIMSS).
The aim of this study is to identify novel substances produced from medicinal plants and use them to develop analgesic and anti-inflammatory molecules.
Who can participate?
Breast cancer patients, post menopause, receiving an aromatase inhibitor and suffer from AIMSS.
What does the study involve?
Participants will be randomly allocated to receive the moringa oleifera leaf extract on a daily basis, or placebo for 30 days.
What are the possible benefits and risks of participating?
Benefits: Improvement from Aromatase Inhibitor - Associated Musculoskeletal Syndrome (AIMSS)
Risks: None
Where is the study run from?
Diponegoro University (Indonesia)
When is the study starting and how long is it expected to run for?
December 2021 to Spetember 2022
Who is funding the study?
Diponegoro University Research Fund (Indonesia)
Who is the main contact?
Dr Yan Wisnu, SpB(K)Onk, yanprajoko7519@gmail.com
Contact information
Principal Investigator
Jl. Willis 18 Semarang
Semarang
50231
Indonesia
 ORCID ID |
0000-0003-2659-9923 |
|---|---|
| Phone | +62 812-2904-279 |
| yanwisnuprajoko@lecturer.undip.ac.id |
Scientific
Jl. Willis 18 Semarang
Semarang
50231
Indonesia
| Phone | +62 812-2904-279 |
|---|---|
| yanprajoko7519@gmail.com |
Public
Jl. Willis 18 Semarang
Semarang
50231
Indonesia
| Phone | +62 812-2904-279 |
|---|---|
| yanwisnuprajoko@lecturer.undip.ac.id |
Study information
| Study design | Single center interventional double blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The effect of moringa oleifera leaf extract on the inflammation status of breast cancer patients receiving aromatase inhibitor therapy |
| Study hypothesis | Moringa Oleifera leaf extract reduces inflammation status of breast cancer patients with estrogen receptor (+) and estrogen receptor (+) receiving Aromatase Inhibitor Therapy |
| Ethics approval(s) | Approved 10/05/2022, Dr Kariadi hospital research ethics committee (Jl. DR. Sutomo No.16, Randusari, Kec. Semarang Sel., Kota Semarang, Jawa Tengah 50244; +62 24 8413476; info@rskariadi.co.id), ref: 1126/EC/KEPK-RSDK/2022 |
| Condition | Moringa Oleifera leaf extract reduces inflammation status of breast cancer patients with estrogen receptor (+) and estrogen receptor (+) receiving Aromatase Inhibitor Therapy |
| Intervention | The research sample was divided into 2 groups: control and treatment groups. The treatment group received a 300 mg capsule of Moringa leaf extract with a daily dose of 600 mg and diclofenac sodium 100 mg/day for analgesia, and the control group received a placebo capsule (2 capsules/day) and sodium diclofenac 100 mg/day for analgesia. Additionally, information was gathered on the subjects’ ESR, CRP, CPK, and ANA levels. This information was collected from the subjects’ medical records. Data on the levels of ESR, CRP, CPK, and ANA were gathered after the therapy was administered in accordance with the study group for 30 days. |
| Intervention type | Supplement |
| Primary outcome measure | Inflammation status is measured using data on the levels of ESR, CRP, CPK, and ANA. Data is gathered pre-treatment and after treatment (30 days) |
| Secondary outcome measures | Measured using blood test: 1. Erythrocyte Sedimentation rate (ESR) measured at pre-treatment and after treatment (30 days) 2. C-Reactive Protein (CRP) measured at pre-treatment and after treatment (30 days) 3. Anti-Nuclear Antibody (ANA) measured at pre-treatment and after treatment (30 days) 4. Creatine Phosphokinase (CPK) measured at pre-treatment and after treatment (30 days) |
| Overall study start date | 10/12/2021 |
| Overall study end date | 28/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 70 |
| Total final enrolment | 78 |
| Participant inclusion criteria | 1. Breast cancer patient 2. Post menopause 3. Imunohistokimia Estrogen receptor (+), Progesteron receptor (+) 4. Received aromatase inhibitor 5. Patient with Aromatase Inhibitor-Associated Musculoskeletal Syndrome |
| Participant exclusion criteria | 1. Emergency condition that needs operation 2. Visceral metastasis 3. History of previous degenerative joint and soft tissue disease (osteoarthritis/rheumatoid arthritis). 4. History of fracture during the last 6 months |
| Recruitment start date | 01/06/2022 |
| Recruitment end date | 28/08/2022 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Semarang
Jawa Tengah
Semarang
50244
Indonesia
Sponsor information
University/education
Jl. Prof. Sudarto
Tembalang
Kec. Tembalang
Kota Semarang
Jawa Tengah
Semarang
50275
Indonesia
| Phone | +62 24 76928010 |
|---|---|
| dean@fk.undip.ac.id | |
| Website | https://fk.undip.ac.id |
"ROR" |
https://ror.org/056bjta22 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- undip, Universitas Diponegoro (UNDIP, Universitas Diponegoro (UNDIP) (Semarang, Indonesia), Universitas Diponegoro (UNDIP) Semarang, UNIVERSITAS DIPONEGORO The Excellent Research University, Diponegoro University, UNDIP
- Location
- Indonesia
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
19/07/2023: The intention to publish date was changed from 01/01/2023 to 31/12/2023.
01/12/2022: Trial's existence confirmed by Dr Kariadi hospital research ethics committee
