Clinical Trial: Treatment of Hand and Foot Syndrome With Traditional Chinese Medicine Formula LC09 in Patients Who Are Receiving Capecitabine for Colorectal and/or Breast Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 H

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.

Detailed Summary:

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.

Current Primary Outcome:

• Grade of hand foot syndrome over time as measured by NCI CTCAE version 4.03 PPE syndrome criteria [ Time Frame: Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended (up to 6 weeks) ]
  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.
• Assessment of patient reported pain using a 1-10 score. [ 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 is collected on a diary card that subjects fill out once daily.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Instrumental Activities of Daily Living Scale [ Time Frame: Baseline and after the intervention completed (up to 6 weeks) ]
  Performance assessment on 8 daily tasks
• Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Baseline and after the intervention completed (up to 6 weeks) ]
  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.
• Chemotherapy completion rate [ Time Frame: After the intervention completed (up to 6 weeks) ]
  Proportion of patients having tolerated established 2-week chemotherapy in each arms.
• Incidence of reduced dosage of capecitabine thereby [ Time Frame: After the intervention completed (up to 6 weeks) ]
  Reduced dosage of capecitabine thereby because of hand foot syndrome
• Incidence of cessation of capecitabine thereby [ Time Frame: After the intervention completed (up to 6 weeks) ]
  Cessation of capecitabine thereby because of hand foot syndrome

Original Secondary Outcome: Same as current

Information By: China-Japan Friendship Hospital

Dates:
Date Received: May 26, 2016
Date Started: June 2016
Date Completion:
Last Updated: June 4, 2016
Last Verified: January 2016