Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection.

Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection. - Objective and subjective assessment of the lymphedema in breast cancer patients who underwent sentinel lymph node biopsy or axillary lymph node dissection.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000034806

Enrollment

600

Registered

2018-11-12

Start date

2018-11-12

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >20 - ECOG performance status of 0-2 - Written informed consent must be obtained from all participants before enrollment

Exclusion criteria

Exclusion criteria: - Participants with recurrence - Participants under adjuvant chemotherapy and radiotherapy - Participants with history of bilateral SLNB or ALND - Participants with upper arm paralysis for a reason other than lymphedema - Participants with disease other than breast cancer, which possibly cause lymphedema - Participants with systemic edema for some systemic disease such as renal failure and heart failure - Participants who physician judges inadequate for this trial - Participants with metal device such as pacemaker - Participants with pregnancy or suspicious pregnancy

Design outcomes

Primary

Measure	Time frame
The frequency of lymphedema after surgery based on subjective and objective assessment by surgical procedure	—

Secondary

Measure	Time frame
1. The correlation between subjective assessment (PRO-CTCAE JAPANESE ver1.0; "frequency", "severity", "interference") and objective assessment (the difference of upper arm diameter between right and left, the ratio of external cell water and total body water [ECW/TBW] with InBody770) 2. The difference of the lymphedema frequency by cut off point of objective assessment 3. The correlation between body mass index (BMI) and the lymphedema frequency based on subjective and objective assessment 4. The lymphedema frequency by postoperative year	—

Measure

Time frame

1. The correlation between subjective assessment (PRO-CTCAE JAPANESE ver1.0; "frequency", "severity", "interference") and objective assessment (the difference of upper arm diameter between right and left, the ratio of external cell water and total body water [ECW/TBW] with InBody770) 2. The difference of the lymphedema frequency by cut off point of objective assessment 3. The correlation between body mass index (BMI) and the lymphedema frequency based on subjective and objective assessment 4. The lymphedema frequency by postoperative year

—

Countries

Japan

Contacts

Public ContactMitsuo Terada

Aichi Cancer Center Department of breast oncology

mterada@aichi-cc.jp052-762-6111

Outcome results