Breast CancerPhase 1/2NCT07067307
Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
A Phase 1/2 study testing melatonin in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Melatonin is an attractive candidate with anticancer activities previously reported in various preclinical and clinical studies. Melatonin not only involves regulating biological rhythms and endocrine function but also functions in the occurrence, development, and treatment of cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2025to Mar 2026
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis with primary invasive breast cancer.
- Patients eligible for receiving neoadjuvant chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (aspartate aminotransferase and alanine aminotransferase ≤ 2.5times the upper limit of normal, serum total bilirubin < 1.5 mg/dl), renal function (creatinine < 1.5 mg/dl)
Who cannot join
- Patients with metastatic or non-invasive disease.
- Patients previously received chemotherapy within one month preceding randomization.
- Patients who were previously taking melatonin.
- Hypersensitivity to melatonin.
- Patients with autoimmune diseases.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mona Mohammed Eltamalawy, Ph.D. in Clinical Pharmacy contact
About this study
Official title: Clinical Evaluation of Melatonin Concomitant Use With Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients
Melatonin is an attractive candidate with anticancer activities previously reported in various preclinical and clinical studies. Melatonin not only involves regulating biological rhythms and endocrine function but also functions in the occurrence, development, and treatment of cancer. There is a number of possible mechanisms by which melatonin may exert its anticancer effects. These mechanisms may include potent antioxidant, immunomodulating, oncostatic, antiproliferative, and estrogen-modulating properties. Regarding the immune-potentiating effects, melatonin increases the activity of lymphocytes, monocyte/ macrophage, and natural killer cells. Melatonin may also exert antiangiogenic and direct apoptotic effects. These activities, except for free-radical scavenging, are believed to be receptor-mediated through Melatonin-1 and Melatonin-2 receptors.
Preclinical studies have demonstrated the antitumor effects of melatonin when used alone and enhanced effects for chemotherapy when used in combination. Melatonin has shown positive results in a number of clinical trials on patients with cancer. The effect of melatonin in early stages and locally advanced breast cancer is still questioned.
Also the effect of melatonin on the development and severity of various chemotherapy-induced toxicities in breast cancer patients will be investigated.
- Conditions
- Breast Cancer
- Being tested
- melatonin, Placebo
- Keywords
- melatonion, chemotherapy induced toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
melatonin 20 mg tablet once daily at bedtime
PlaceboDrug
Placebo once daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | Melatonin 20 mg once daily at bedtime Receives: Drug: melatonin |
| Control | Placebo comparator | Placebo once daily at bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response type to chemotherapy using Residual Cancer Burden (RCB) index.
Residual Cancer Burden index (RCB) is a validated, continuous index combining primary tumor size, cellularity, and nodal metastasis either pathological complete response or presence of residual tumor ( minimal, moderate, or extensive).
The primary outcome is the difference in the mean or median RCB index between intervention and control group.
Measured: At time of surgery after termination of neoadjuvant chemotherapy protocol
Secondary outcomes (5)
Presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue.
Difference between study arms regarding presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue. This will reflect tumor's biology and the immune response it elicits.
Measured: At time of surgery after termination of neoadjuvant chemotherapy protocol
The change in radiological tumor size
The change in radiological tumor size (expressed as the largest diameter) compared between both groups.
The tumor size will be obtained from standard bilateral mammography and ultrasound imaging of the breast.
Measured: At time of surgery after termination of neoadjuvant chemotherapy protocol
Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy
Incidence of development and grading of some chemotherapy-induced toxicities (myelosuppression, mucositis, and peripheral sensory neuropathy) will be assessed using National Cancer Institute - Common Terminology Criteria for Adverse Events version 5
Measured: throughout the period of neoadjuvant chemotherapy protocol (about 6 months)
The proportion of patients achieving pathologic complete response (RCB-0) after neoadjuvant therapy in each group.
Measured: At surgery after completion of neoadjuvant chemotherapy.
Difference in proportions across RCB categories.
Comparison of the distribution of RCB categories (0, I, II, III) between intervention and control group.
0: No residual disease, 1: minimal residual disease, II: moderate residual disease, III: Severe residual disease.
Measured: At surgery after completion of neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (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 Mansoura 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohammed El-Tamalawy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067307
- Sponsor's protocol ID
- 2024-104
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Melatonin Concomitant Use With Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07067307
- Acronym / sponsor ID
- 2024-104
- Conditions
- Breast Cancer
- Keywords
- melatonion, chemotherapy induced toxicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 16 Jul 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.
Melatonin is an attractive candidate with anticancer activities previously reported in various preclinical and clinical studies. Melatonin not only involves regulating biological rhythms and endocrine function but also functions in the occurrence, development, and treatment of cancer. There is a number of possible mechanisms by which melatonin may exert its anticancer effects. These mechanisms may include potent antioxidant, immunomodulating, oncostatic, antiproliferative, and estrogen-modulating properties. Regarding the immune-potentiating effects, melatonin increases the activity of lymphocytes, monocyte/ macrophage, and natural killer cells. Melatonin may also exert antiangiogenic and direct apoptotic effects. These activities, except for free-radical scavenging, are believed to be receptor-mediated through Melatonin-1 and Melatonin-2 receptors.
Preclinical studies have demonstrated the antitumor effects of melatonin when used alone and enhanced effects for chemotherapy when used in combination. Melatonin has shown positive results in a number of clinical trials on patients with cancer. The effect of melatonin in early stages and locally advanced breast cancer is still questioned.
Also the effect of melatonin on the development and severity of various chemotherapy-induced toxicities in breast cancer patients will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: melatoninMelatonin 20 mg once daily at bedtime |
| Control | Placebo comparator | Drug: PlaceboPlacebo once daily at bedtime |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis with primary invasive breast cancer.
- Patients eligible for receiving neoadjuvant chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (aspartate aminotransferase and alanine aminotransferase ≤ 2.5times the upper limit of normal, serum total bilirubin < 1.5 mg/dl), renal function (creatinine < 1.5 mg/dl)
Key exclusion criteria (6 listed)
- Patients with metastatic or non-invasive disease.
- Patients previously received chemotherapy within one month preceding randomization.
- Patients who were previously taking melatonin.
- Hypersensitivity to melatonin.
- Patients with autoimmune diseases.
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 |
|---|---|---|
| melatoninmelatonin 20 mg tablet once daily at bedtime | Drug | Melatonin |
| PlaceboPlacebo once daily at bedtime | Drug | Control |
Primary outcome
Response type to chemotherapy using Residual Cancer Burden (RCB) index.
Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol
Residual Cancer Burden index (RCB) is a validated, continuous index combining primary tumor size, cellularity, and nodal metastasis either pathological complete response or presence of residual tumor ( minimal, moderate, or extensive). The primary outcome is the difference in the mean or median RCB index between intervention and control group.
5 secondary outcomes
Presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue.
Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol
The change in radiological tumor size
Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol
Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy
Time frame: throughout the period of neoadjuvant chemotherapy protocol (about 6 months)
The proportion of patients achieving pathologic complete response (RCB-0) after neoadjuvant therapy in each group.
Time frame: At surgery after completion of neoadjuvant chemotherapy.
Difference in proportions across RCB categories.
Time frame: At surgery after completion of neoadjuvant therapy
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 16 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mona Mohammed Eltamalawy, Ph.D. in Clinical Pharmacy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing melatonin in people with Breast Cancer, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 6 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mona Mohammed Eltamalawy, Ph.D. in Clinical Pharmacy (+201220650700, mona.m.eltamalawy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response type to chemotherapy using Residual Cancer Burden (RCB) index. (time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol). 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 16 Jul 2025.