Treatment of Hand and Foot Syndrome With Traditional Chinese Medicine Formula LC09 in Patients Who Are Receiving Capecitabine for Colorectal and/or Breast Cancer
Primary Purpose
Hand Foot Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Traditional Chinese Medicine Formula LC09
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hand Foot Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm I
Arm II
Arm Description
Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Instrumental Activities of Daily Living Scale
Performance assessment on 8 daily tasks
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.
Chemotherapy completion rate
Proportion of patients having tolerated established 2-week chemotherapy in each arms.
Incidence of reduced dosage of capecitabine thereby
Reduced dosage of capecitabine thereby because of hand foot syndrome
Incidence of cessation of capecitabine thereby
Cessation of capecitabine thereby because of hand foot syndrome
Full Information
NCT ID
NCT02794493
First Posted
May 26, 2016
Last Updated
July 23, 2019
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02794493
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
April 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Foot Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
Intervention Type
Drug
Intervention Name(s)
Traditional Chinese Medicine Formula LC09
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Grade of hand foot syndrome over time as measured by NCI CTCAE version 4.03 PPE syndrome criteria
Description
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)
Title
Assessment of patient reported pain using a 1-10 score.
Description
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)
Secondary Outcome Measure Information:
Title
Instrumental Activities of Daily Living Scale
Description
Performance assessment on 8 daily tasks
Time Frame
Baseline and after the intervention completed (up to 6 weeks)
Title
Dermatology Life Quality Index (DLQI) Total Score
Description
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)
Title
Chemotherapy completion rate
Description
Proportion of patients having tolerated established 2-week chemotherapy in each arms.
Time Frame
After the intervention completed (up to 6 weeks)
Title
Incidence of reduced dosage of capecitabine thereby
Description
Reduced dosage of capecitabine thereby because of hand foot syndrome
Time Frame
After the intervention completed (up to 6 weeks)
Title
Incidence of cessation of capecitabine thereby
Description
Cessation of capecitabine thereby because of hand foot syndrome
Time Frame
After the intervention completed (up to 6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
32597691
Citation
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.
Results Reference
derived
Learn more about this 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
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