Advanced Breast Cancer
Conditions
Keywords
Cancer ablation, Life information rehabilitation therapy
Brief summary
The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.
Detailed description
By enrolling patients with unresectable breast cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Interventions
DEVICECancer ablation
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Sponsors
Shengxin Biotechnology Institute, Beijing
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies * Body tumor 1-6, with at least one tumor length \> 2 cm * KPS ≥ 70, lifespan \> 6 months * Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion criteria
* Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief degree of tumors | 3 months | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress free survival（PFS） | 1 year | The duration between treatment and cancer recurrence |
| Overall survival（OS） | 3 years | The duration between treatment and patient pass away |
Countries
China
Outcome results
None listed