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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Grade of hand foot syndrome over time as measured by NCI CTCAE version 4.03 PPE syndrome criteria
Grading of PPE by NCI CTC criteria is collected on a diary card that subjects fill out once daily. Investigators assess and fill the grading into the case report form every week.
Time frame: Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended (up to 6 weeks)
Assessment of patient reported pain using a 1-10 score.
Assessment of patient reported pain using a 1-10 score is collected on a diary card that subjects fill out once daily.
Time frame: Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended(up to 6 weeks)
Instrumental Activities of Daily Living Scale
Performance assessment on 8 daily tasks
Time frame: Baseline and after the intervention completed (up to 6 weeks)
Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a 10-item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.
Time frame: Baseline and after the intervention completed (up to 6 weeks)
Chemotherapy completion rate
Proportion of patients having tolerated established 2-week chemotherapy in each arms.
Time frame: After the intervention completed (up to 6 weeks)
Incidence of reduced dosage of capecitabine thereby
Reduced dosage of capecitabine thereby because of hand foot syndrome
Time frame: After the intervention completed (up to 6 weeks)
Incidence of cessation of capecitabine thereby
Cessation of capecitabine thereby because of hand foot syndrome
Time frame: After the intervention completed (up to 6 weeks)
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