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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

Primary Purpose

Hand Foot Syndrome

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Traditional Chinese Medicine Formula LC09

Placebo

About this trial

This is an interventional treatment trial for Hand Foot Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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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

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