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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794493
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yanni Lou, China-Japan Friendship Hospital

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE April 1, 2015
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2016)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hand and Foot Syndrome With Traditional Chinese Medicine Formula LC09 in Patients Who Are Receiving Capecitabine for Colorectal and/or Breast Cancer
Official Title  ICMJE 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
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hand Foot Syndrome
Intervention  ICMJE
  • Drug: Traditional Chinese Medicine Formula LC09
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Arm I
    Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
    Intervention: Drug: Traditional Chinese Medicine Formula LC09
  • Placebo Comparator: Arm II
    Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
    Intervention: Other: Placebo
Publications * Yu R, Wu X, Jia L, Lou Y. Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, and Parallel-Controlled Trial. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420928466. doi: 10.1177/1534735420928466.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2016)
156
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 25, 2018
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02794493
Other Study ID Numbers  ICMJE 2015BAI04B07
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanni Lou, China-Japan Friendship Hospital
Study Sponsor  ICMJE China-Japan Friendship Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China-Japan Friendship Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP