Trial · NCT07067307
Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT07067307, Phase 1, Phase 2, Not yet recruiting, Mansoura University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy. Trials, record NCT07067307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07067307
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
- NCT number
- NCT07067307
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Mansoura University
- Conditions
- Breast Cancer
- Interventions
- melatonin, Placebo
- First posted
- 2025-07-16
- Last updated
- 2025-07-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response type to chemotherapy using Residual Cancer Burden (RCB) index. | 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. |
| Secondary | Presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue. | At time of surgery after termination of neoadjuvant chemotherapy protocol | 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. |
| Secondary | The change in radiological tumor size | At time of surgery after termination of neoadjuvant chemotherapy protocol | 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. |
| Secondary | Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy | throughout the period of neoadjuvant chemotherapy protocol (about 6 months) | 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 |
| Secondary | The proportion of patients achieving pathologic complete response (RCB-0) after neoadjuvant therapy in each group. | At surgery after completion of neoadjuvant chemotherapy. | |
| Secondary | Difference in proportions across RCB categories. | At surgery after completion of neoadjuvant therapy | 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. |
| Other | Adverse effects | throughout the period of neoadjuvant chemotherapy protocol (about 6 months) | Any adverse/side effect will be evaluated |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07067307
GET https://conductscience.org/api/trials/v1/NCT07067307/registered