Breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention group: This study is a non-randomized before–after clinical trial with no control group. The study includes 10 patients with end-stage metastatic breast cancer without effective standard
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnostic confirmation: Patients with histopathologically confirmed Stage IV breast cancer with involvement of at least one distant organ (bone, lung, or liver). Treatment status: Patients who have received and experienced failure of all available and accessible standard lines of therapy. Treatment refusal: Patients who decline further chemotherapy and radiotherapy. Organ function: Adequate hepatic and renal function and acceptable hematologic parameters (e.g., serum creatinine <1.5 × the upper limit of normal). Informed consent: Provision of written informed consent prior to enrollment.
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding. History of cardiovascular diseases. History of thromboembolic disorders. Known hypersensitivity or allergic reactions to methylene blue during treatment. History of bleeding disorders or abnormal blood coagulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The investigation of pain intensity during the follow-up period. Timepoint: At baseline and monthly throughout the minimum 6-month follow-up period. Method of measurement: Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0–10) or the Visual Analog Scale (VAS).;Assessment of changes in patients’ quality of life across physical, emotional, social, and overall well-being domains. Timepoint: At study entry and monthly during the follow-up period. Method of measurement: Validated questionnaires including the EORTC QLQ-C30 and the FACT-B for breast cancer patients.;Improvement or control of common symptoms including nausea, vomiting, dyspnea, severe fatigue, anorexia, and edema. Timepoint: At baseline and monthly throughout the follow-up period. Method of measurement: Standardized tools such as the Edmonton Symptom Assessment System (ESAS) or the MD Anderson Symptom Inventory (MDASI), with each symptom scored on a 0–10 scale.;The investigation of the frequency and duration of unnecessary emergency department visits and hospital admissions. Timepoint: Continuously monitored throughout the minimum 6-month follow-up period. Method of measurement: Documentation of the number of hospital admissions and length of stay based on medical records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from study enrollment to death from any cause. Timepoint: Minimum of 6 months, with extended follow-up up to 1–2 years in surviving patients if positive signals are observed. Method of measurement: Survival status will be recorded through clinical follow-up visits and medical records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDaryoush Hamidi Alamdari
Mashhad University of Medical Sciences
Outcome results
None listed