Bioinformation Therapy for Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title:

Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240224
• Other study ID #: Bioinformation-breast
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2, 2017
• Est. completion date: September 2, 2018

Study information

• Verified date: August 2017
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable breast cancer.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2, 2018
• Est. primary completion date: September 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Cancer ablation
Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.

Drug:
• Life information rehabilitation therapy
Each treatment: one bottle solution each day, consecutive 3 months, oral administration

Locations

Country	Name	City	State
China	Fuda cancer institute of Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Shengxin Biotechnology Institute, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief degree of tumors	It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)	3 months
Secondary	Progress free survival(PFS)	The duration between treatment and cancer recurrence	1 year
Secondary	Overall survival(OS)	The duration between treatment and patient pass away	3 years