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

Hand Foot Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794493
• Other study ID #: 2015BAI04B07
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2015
• Est. completion date: April 25, 2018

Study information

• Verified date: July 2019
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 25, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Foot Syndrome
• Hand-Foot Syndrome
• Syndrome

Intervention

Drug:
• Traditional Chinese Medicine Formula LC09

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended (up to 6 weeks)
Primary	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.	Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended(up to 6 weeks)
Secondary	Instrumental Activities of Daily Living Scale	Performance assessment on 8 daily tasks	Baseline and after the intervention completed (up to 6 weeks)
Secondary	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.	Baseline and after the intervention completed (up to 6 weeks)
Secondary	Chemotherapy completion rate	Proportion of patients having tolerated established 2-week chemotherapy in each arms.	After the intervention completed (up to 6 weeks)
Secondary	Incidence of reduced dosage of capecitabine thereby	Reduced dosage of capecitabine thereby because of hand foot syndrome	After the intervention completed (up to 6 weeks)
Secondary	Incidence of cessation of capecitabine thereby	Cessation of capecitabine thereby because of hand foot syndrome	After the intervention completed (up to 6 weeks)