A phase II randomized clinical trial to determine the effectiveness of goreisan and saireito for lower limb lymphedema in women treated for gynecologic cancer

Phase 2

Suspended

• Conditions: ower Limb Lymphedema; Lymphedema; D008209

• Registration Number: JPRN-jRCT1041190019
• Lead Sponsor: Kajiyama Hiroaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1) Patients who underwent uterine malignancy surgery including retroperitoneal lymph node dissection or surgical operation of the uterine appendix malignant tumor by preoperative diagnosis of gynecological malignancy
2) Patients diagnosed with secondary lymphedema in 1)
3) Patients with ECOG-PS 0 or 1
4) Patients whose main organ functions are adequately maintained
(A) White blood cell count 3,500 / mm 3 12 000 / mm 3
(B) Number of neutrophils 1,500 / mm 3
(C) Number of platelets 100,000 / mm 3
(D) Hb 9.0 g / dL
(E) AST,ALT 100 IU / L
(F) Creatinine 1.2 mg / dL
5) Patients whose age at registration is 20 years or older
6) Patients who have obtained document consent

Exclusion Criteria

1) Patients who are allergic to the ingredients of traditional Chinese medicine or goriso-san/saireito
2) Patients with severe complications (heart failure, renal failure, liver failure, hypoactive nutrition etc.) and severe mental illness
3) Patients whose oral ingestion is impossible
4) Patients diagnosed with primary lymphedema
5) Patients with lower extremity vein thrombosis
6) In addition, patients judged unsuitable for doctors to safely carry out this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of calculated limb volume

Secondary Outcome Measures

Name	Time	Method
Comparison of limb water<br>Comparison of QOL indicator