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

NCT02794493 | Completed Phase 3

• 1 other identifier: 2015BAI04B07
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hand Foot Syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Instrumental Activities of Daily Living Scale

  Baseline and after the intervention completed (up to 6 weeks)

• Dermatology Life Quality Index (DLQI) Total Score

  Baseline and after the intervention completed (up to 6 weeks)

• Chemotherapy completion rate

  After the intervention completed (up to 6 weeks)

• Incidence of reduced dosage of capecitabine thereby

  After the intervention completed (up to 6 weeks)

• Incidence of cessation of capecitabine thereby

  After the intervention completed (up to 6 weeks)

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily.

Drug: Traditional Chinese Medicine Formula LC09

Arm II

PLACEBO COMPARATOR

Patients receive placebo by soaking their affected hand and feet 20 min twice daily.

Other: Placebo

Interventions

Traditional Chinese Medicine Formula LC09 DRUG

Arm I

Placebo OTHER

Arm II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Related Publications (1)

• 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.

  PMID: 32597691 DERIVED

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 9, 2016
• Study Start: April 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: April 25, 2018
• Last Updated: July 25, 2019

Record last verified: 2019-07