- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02794493
Treatment of Hand and Foot Syndrome With Traditional Chinese Medicine Formula LC09 in Patients Who Are Receiving Capecitabine for Colorectal and/or Breast Cancer
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects must meet the following criteria to be eligible for the study:
- 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;
- Level 1 or above HFS after receiving capecitabine as part of routine standard care;
- Plan to receive capecitabine as part of routine more than 2 weeks;
- ECOG performance status 0-2;
- Life expectancy greater than or equal to 3 months;
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)
- 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:
- Concurrent with level 1 or above peripheral neuropathy (such as diabetic neuropathy or chemotherapy induced peripheral neuropathy);
- Other acute or chronic inflammatory conditions or infections of the hands or feet that would complicate safety, application of topical creams, or study endpoints;
- Currently taking other treatment for PPE (including topical urea cream, pyridoxine, celecoxib, compound matrine injection and deproteinized calf blood extractive injection);
- History of severe or uncontrolled organic disease or infection, such as heart, pulmonary or renal failure that cause the termination of chemotherapy;
- Pregnant (positive pregnancy test) or nursing women;
- Participating in other clinical trial currently or within 4 weeks.
Study Plan
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015BAI04B07
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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