Breast CancerPhase 3NCT06811220
The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
A Phase 3 study testing Hespiridin and Diosmin in people with Breast Cancer, run by Alexandria University.
Trial summary
The aim of this study is evaluation of the potential neuroprotective effect of oral hesperidin and diosmin in reducing paclitaxel- induced peripheral neuropathy in the treatment of breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hespiridin and Diosmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients over 18 years of age with pathologically confirmed breast cancer.
- Breast cancer patients candidate for chemotherapy and will receive paclitaxel.
- Patients having an eastern cooperative oncology group (ECOG) score more than 2
Who cannot join
- Patients with signs and symptoms of clinical neuropathy at baseline.
- Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
- Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
- Patients who have previously received chemotherapy.
- Hepatic impaired patients.
- Patient with history of allergy to hesperidin.
Show all 10Show fewer
- Patients with history of allergy to diosmin.
- Renal impaired patients.
- Patient inadherent to paclitaxel.
- Patients inadherent to the administered hesperidin and diosmin during the study period.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is evaluation of the potential neuroprotective effect of oral hesperidin and diosmin in reducing paclitaxel- induced peripheral neuropathy in the treatment of breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Hespiridin and Diosmin
- Keywords
- Paclitaxel-induced peripheral neuropathy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hespiridin and DiosminDrug
Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group): 70 patients will receive Paclitaxel only as neoadjuvant chemotherapy as one | No intervention | Patients will receive Paclitaxel only as neoadjuvant chemotherapy as one cycle every 21 days (i.e. 3 weeks) as 175 mg/m2. |
| Group 2 (Intervention group): patients which will receive Paclitaxel plus Hespiridin and Diosmin. | Active comparator | patients which will receive Paclitaxel plus Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet) 2 tablets daily, i.e. 1 tablet at midday and 1 tablet in the evening, at meal times. Receives: Drug: Hespiridin and Diosmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum levels of the following biomarker:Nerve growth factor (NGF)
Nerve growth factor (NGF) measured in Pg/ml
Measured: 3 months
Changes in serum levels of the following biomarker :Malondialdehyde (MDA).
Malondialdehyde (MDA) is measured in Micro mole/L
Measured: 3 months
Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β).
Interleukin-1 beta (IL-1 β) is measured in Pg/ml
Measured: 3 months
Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) .
Tumor necrosis Factor-Alpha (TNF- α) is measured in Pg/ml
Measured: 3 months
Secondary outcomes (2)
A- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria assessed.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria ; where its classified as mild, moderate and severe peripheral neuropathy according to severity of subjective peripheral neuropathy reported by the patient.
Measured: at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).
B- Measurement of the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire assessed.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire where the minumum score is zero and the maximum score is 16. The higher the score the better the quality of life.
Measured: at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start27 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811220
- Sponsor's protocol ID
- 0108808
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Administration of Hesperidin and Diosmin in Reducing Paclitaxel-induced Peripheral Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06811220
- Acronym / sponsor ID
- 0108808
- Conditions
- Breast Cancer
- Keywords
- Paclitaxel-induced peripheral neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 27 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is evaluation of the potential neuroprotective effect of oral hesperidin and diosmin in reducing paclitaxel- induced peripheral neuropathy in the treatment of breast cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control group): 70 patients will receive Paclitaxel only as neoadjuvant chemotherapy as one | No intervention | –Patients will receive Paclitaxel only as neoadjuvant chemotherapy as one cycle every 21 days (i.e. 3 weeks) as 175 mg/m2. |
| Group 2 (Intervention group): patients which will receive Paclitaxel plus Hespiridin and Diosmin. | Active comparator | Drug: Hespiridin and Diosminpatients which will receive Paclitaxel plus Daflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet) 2 tablets daily, i.e. 1 tablet at midday and 1 tablet in the evening, at meal times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients over 18 years of age with pathologically confirmed breast cancer.
- Breast cancer patients candidate for chemotherapy and will receive paclitaxel.
- Patients having an eastern cooperative oncology group (ECOG) score more than 2
Key exclusion criteria (10 listed)
- Patients with signs and symptoms of clinical neuropathy at baseline.
- Patients with diabetes mellitus, alcoholic disease, heart failure, pregnant or lactating women.
- Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
- Patients who have previously received chemotherapy.
- Hepatic impaired patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hespiridin and DiosminDaflon® (50 mg Hesperidin and Micronized purified flavonoid fraction (MPFF) 450 diosmin combination one film coated tablet) | Drug | Group 2 (Intervention group): patients which will receive Paclitaxel plus Hespiridin and Diosmin. |
Primary outcome
Changes in serum levels of the following biomarker:Nerve growth factor (NGF)
Time frame: 3 months
Nerve growth factor (NGF) measured in Pg/ml
Changes in serum levels of the following biomarker :Malondialdehyde (MDA).
Time frame: 3 months
Malondialdehyde (MDA) is measured in Micro mole/L
Changes in serum levels of the following biomarker:Interleukin-1 beta (IL-1 β).
Time frame: 3 months
Interleukin-1 beta (IL-1 β) is measured in Pg/ml
Changes in serum levels of the following biomarker: Tumor necrosis Factor-Alpha (TNF- α) .
Time frame: 3 months
Tumor necrosis Factor-Alpha (TNF- α) is measured in Pg/ml
2 secondary outcomes
A- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria assessed.
Time frame: at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).
B- Measurement of the quality of life using the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity FACT/GOG-NTX (Version 4) questionnaire assessed.
Time frame: at baseline and after each cycle of neoadjuvant chemotherapy where the length of each cycle is 21 days (i.e. every 21 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hespiridin and Diosmin in people with Breast Cancer, run by Alexandria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa AE Hassan Mahmoud, Master (03-01148898967, mohassan1869@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum levels of the following biomarker:Nerve growth factor (NGF) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.