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Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients with breast cancer who received axillary lymphnode dissection

Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients with breast cancer who received axillary lymphnode dissection - Phase 3 study of relationship between peripheral venous reservation and lymphedema of upper limbs in patients received axillary lymphnode dissection

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003497
Enrollment
50
Registered
2010-04-17
Start date
2009-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Patients receive peripheral venous reservation on the non-postoperative arm with adjuvant chemotherapy, Doxorubicin 50-60mg/square meter,or Epirubicin 60-100mg/square meter followed Docetaxel 60-75mg

Sponsors

Gunma Prefectural Cancer Center
Lead Sponsor
Saitama Red Cross Hospital Isesaki Municipal Hospital
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Unilateral breast cancer 2) Patients who received axillary lymphnode dissection level I or more. 3) Sufficient organ function 4) No incidence of lymphedema of upper limbs (including doctor's clinical determination ) 5) Written informed consent 6) Suitable for receiving adjuvant chemotherapy including Anthracycline followed Docetaxel for four couses.

Exclusion criteria

Exclusion criteria: 1) Bilateral breast cancer. 2) Severe disease (hepatic, renal, heart or endocrine ) 3) Eastern Cooperative Oncology Group performance status (PS) of 2 to 4. 4) No lymphedema of upper limbs subjectively or objectively. 5) Allergic reaction to Anthracycline or/and Docetaxel.6) Other conditions inadequate for this research

Design outcomes

Primary

MeasureTime frame
Incidence of lymphedema of upper limbs

Secondary

MeasureTime frame
Incidence and grade of phlebitis. Difficulty of peripheral venous reservation

Countries

Japan

Contacts

Public ContactYasuhiro Yanagita

Gunma Prefectural Cancer Center Department of Breast Oncology

yyanagita@gunma-cc.jp+81-276-38-0771

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026