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

July 23, 2019 updated by: Yanni Lou, China-Japan Friendship Hospital

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet the following criteria to be eligible for the study:

  1. Histologically confirmed colorectal cancer or breast cancer, of which colorecta cancer is advanced or undergoing adjuvant therapy after radical resection and breast cancer is at the stage of recurrence or metastasis;
  2. Level 1 or above HFS after receiving capecitabine as part of routine standard care;
  3. Plan to receive capecitabine as part of routine more than 2 weeks;
  4. ECOG performance status 0-2;
  5. Life expectancy greater than or equal to 3 months;
  6. No serious heart, liver, kidney and other important viscera dysfunction, as defined below:

    • absolute neutrophil count greater than or equal to 1.5 x 10(9)/L
    • platelet count greater than or equal to 100 x 10(9)/L
    • hemoglobin greater than or equal to 9.0 g/dL
    • total bilirubin less than or equal to 1.5 times the ULN
    • AST/SGOT and ALT/SGPT less than or equal to 2.5 times the ULN (or less than or equal to 5 times the ULN if liver function abnormalities due to underlying malignancy)
    • creatinine less than or equal to 1.5 times the ULN
    • creatinine clearance greater than or equal to 60 ml/min (by Cockcroft-Gault)
  7. Ability to cooperate with HFS grade evaluation, understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Subjects meeting any of the following criteria are ineligible for study entry:

  1. Concurrent with level 1 or above peripheral neuropathy (such as diabetic neuropathy or chemotherapy induced peripheral neuropathy);
  2. Other acute or chronic inflammatory conditions or infections of the hands or feet that would complicate safety, application of topical creams, or study endpoints;
  3. Currently taking other treatment for PPE (including topical urea cream, pyridoxine, celecoxib, compound matrine injection and deproteinized calf blood extractive injection);
  4. History of severe or uncontrolled organic disease or infection, such as heart, pulmonary or renal failure that cause the termination of chemotherapy;
  5. Pregnant (positive pregnancy test) or nursing women;
  6. Participating in other clinical trial currently or within 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
Placebo Comparator: Arm II
Patients receive placebo by soaking their affected hand and feet 20 min twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended(up to 6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Instrumental Activities of Daily Living Scale
Time Frame: Baseline and after the intervention completed (up to 6 weeks)
Performance assessment on 8 daily tasks
Baseline and after the intervention completed (up to 6 weeks)
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.
Baseline and after the intervention completed (up to 6 weeks)
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.
After the intervention completed (up to 6 weeks)
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
After the intervention completed (up to 6 weeks)
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
After the intervention completed (up to 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

April 25, 2018

Study Registration Dates

First Submitted

May 26, 2016

First Submitted That Met QC Criteria

June 4, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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