Bioinformation Therapy for Breast Cancer

Overview

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

Full Title of Study: “Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2, 2018

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

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Cancer ablation
    • In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
  • Active Comparator: Life information rehabilitation therapy
    • In this group, the patients will drink “Qilisheng” Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
  • Experimental: Combination therapy
    • In this group, the patients will receive combination therapy, including ablation and life information rehabilitation therapy. They will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (> 2 cm), then drink “Qilisheng” Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).
  • No Intervention: Control
    • In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).

Clinical Trial Outcome Measures

Primary Measures

  • Relief degree of tumors
    • Time Frame: 3 months
    • It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)

Secondary Measures

  • Progress free survival(PFS)
    • Time Frame: 1 year
    • The duration between treatment and cancer recurrence
  • Overall survival(OS)
    • Time Frame: 3 years
    • The duration between treatment and patient pass away

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fuda Cancer Hospital, Guangzhou
  • Collaborator
    • Shengxin Biotechnology Institute, Beijing
  • Provider of Information About this Clinical Study
    • Sponsor

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