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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Diponegoro University
Funder	Universitas Diponegoro

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Dr Yan Wisnu Prajoko
Principal investigator

Jl. Willis 18 Semarang
Semarang
50231
Indonesia

ORCID ID	0000-0003-2659-9923
Phone	+62 812-2904-279
Email	yanwisnuprajoko@lecturer.undip.ac.id

Dr Yan Wisnu Prajoko
Scientific

Jl. Willis 18 Semarang
Semarang
50231
Indonesia

Phone	+62 812-2904-279
Email	yanprajoko7519@gmail.com

Dr Yan wisnu Prajoko
Public

Jl. Willis 18 Semarang
Semarang
50231
Indonesia

Phone	+62 812-2904-279
Email	yanwisnuprajoko@lecturer.undip.ac.id

Study information

Primary study design	Interventional
Study design	Single center interventional double blinded randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	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 objectives	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
Health condition(s) or problem(s) studied	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(s)	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)
Key secondary outcome measure(s)	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)
Completion date	28/09/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	70
Total final enrolment	78
Key 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
Key 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
Date of first enrolment	01/06/2022
Date of final enrolment	28/08/2022

Locations

Countries of recruitment

Indonesia

Study participating centre

Dr Kariadi hospital

Jl. Dr. Sutomo No. 16
Semarang
Jawa Tengah
Semarang
50244
Indonesia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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