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

Phase 3

Completed

• Conditions: Hand Foot Syndrome
• Interventions: Other: Placebo; Drug: Traditional Chinese Medicine Formula LC09

• Registration Number: NCT02794493
• Lead Sponsor: China-Japan Friendship Hospital

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 Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-06-04
• Study First Posted: 2016-06-09
• Primary Completion: 2017-12-31
• Study Completion: 2018-04-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	Placebo	Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
Arm I	Traditional Chinese Medicine Formula LC09	Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.

Primary Outcome Measures

Name	Time	Method
Assessment of patient reported pain using a 1-10 score.	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.
Grade of hand foot syndrome over time as measured by NCI CTCAE version 4.03 PPE syndrome criteria	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.

Secondary Outcome Measures

Name	Time	Method
Instrumental Activities of Daily Living Scale	Baseline and after the intervention completed (up to 6 weeks)	Performance assessment on 8 daily tasks
Dermatology Life Quality Index (DLQI) Total Score	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	After the intervention completed (up to 6 weeks)	Proportion of patients having tolerated established 2-week chemotherapy in each arms.
Incidence of cessation of capecitabine thereby	After the intervention completed (up to 6 weeks)	Cessation of capecitabine thereby because of hand foot syndrome
Incidence of reduced dosage of capecitabine thereby	After the intervention completed (up to 6 weeks)	Reduced dosage of capecitabine thereby because of hand foot syndrome