Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-01-01 @ 3:30 PM
Study NCT ID:
NCT02794493
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hand and Foot Syndrome With Traditional Chinese Medicine Formula LC09 in Patients Who Are Receiving Capecitabine for Colorectal and/or Breast Cancer
Sponsor:
China-Japan Friendship Hospital
Organization:
Study Overview
Official Title:
A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of Traditional Chinese Medicine Formula LC09 for Treatment of Capecitabine-Induced Hand and Foot Syndrome
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Hand foot syndrome may be treated or reduced by soaking Traditional Chinese Medicine Formula LC09 in patients receiving capecitabine for colorectal and/or breast cancer.
PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for colorectal or breast cancer.
PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for colorectal or breast cancer.
Detailed Description:
OBJECTIVES:
OBJECTIVES: Determine whether Traditional Chinese Medicine Formula LC09 can treat or reduce the severity of capecitabine-caused hand foot syndrome.
Evaluate the potential toxicity of Traditional Chinese Medicine Formula LC09. OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are randomized to 2 treatment arms.
Arm I: Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
Arm II: Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
OBJECTIVES: Determine whether Traditional Chinese Medicine Formula LC09 can treat or reduce the severity of capecitabine-caused hand foot syndrome.
Evaluate the potential toxicity of Traditional Chinese Medicine Formula LC09. OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are randomized to 2 treatment arms.
Arm I: Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
Arm II: Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: