Hand Foot SyndromePhase 3NCT02794493
Treatment of Hand and Foot Syndrome With Traditional Chinese Medicine Formula LC09 in Patients Who Are Receiving Capecitabine for Colorectal and/or Breast Cancer
A Phase 3 study testing Traditional Chinese Medicine Formula LC09 in people with Hand Foot Syndrome, run by China-Japan Friendship Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hand Foot Syndrome
- What is being tested?
- Traditional Chinese Medicine Formula LC09
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 25 Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Hand Foot Syndrome
- Being tested
- Traditional Chinese Medicine Formula LC09, Placebo
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine Formula LC09Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily. Receives: Drug: Traditional Chinese Medicine Formula LC09 |
| Arm II | Placebo comparator | Patients receive placebo by soaking their affected hand and feet 20 min twice daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Performance assessment on 8 daily tasks
Measured: Baseline and after the intervention completed (up to 6 weeks)
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.
Measured: Baseline and after the intervention completed (up to 6 weeks)
Chemotherapy completion rate
Proportion of patients having tolerated established 2-week chemotherapy in each arms.
Measured: After the intervention completed (up to 6 weeks)
Incidence of reduced dosage of capecitabine thereby
Reduced dosage of capecitabine thereby because of hand foot syndrome
Measured: After the intervention completed (up to 6 weeks)
Incidence of cessation of capecitabine thereby
Cessation of capecitabine thereby because of hand foot syndrome
Measured: After the intervention completed (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start1 Apr 2015
- Primary completion31 Dec 2017
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand Foot SyndromeStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanni Lou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794493
- Sponsor's protocol ID
- 2015BAI04B07
- Status last verified
- Jul 2019
- First submitted
- 26 May 2016
- Last updated
- 25 Jul 2019
- Results posted
- No
Publications
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.
PubMed 32597691
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02794493
- Acronym / sponsor ID
- 2015BAI04B07
- Conditions
- Hand Foot Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Traditional Chinese Medicine Formula LC09Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected hand and feet 20 min twice daily. |
| Arm II | Placebo comparator | Other: PlaceboPatients receive placebo by soaking their affected hand and feet 20 min twice daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine Formula LC09 | Drug | Arm I |
| Placebo | Other | Arm II |
Primary outcome
Grade of hand foot syndrome over time as measured by NCI CTCAE version 4.03 PPE syndrome criteria
Time frame: 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.
Assessment of patient reported pain using a 1-10 score.
Time frame: 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.
5 secondary outcomes
Instrumental Activities of Daily Living Scale
Time frame: Baseline and after the intervention completed (up to 6 weeks)
Dermatology Life Quality Index (DLQI) Total Score
Time frame: Baseline and after the intervention completed (up to 6 weeks)
Chemotherapy completion rate
Time frame: After the intervention completed (up to 6 weeks)
Incidence of reduced dosage of capecitabine thereby
Time frame: After the intervention completed (up to 6 weeks)
Incidence of cessation of capecitabine thereby
Time frame: After the intervention completed (up to 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Derived from this study: PubMed 32597691Yu 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.
Related trials for Hand Foot Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
RecruitingPhase 2
SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
Not yet recruiting
Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
HFS
Not yet recruitingPhase 2
TAR-0520 Gel in Hand and Foot Syndrome
Hand and Foot Syndrome
Active, not recruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
Hand-foot Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Traditional Chinese Medicine Formula LC09 in people with Hand Foot Syndrome, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of hand foot syndrome over time as measured by NCI CTCAE version 4.03 PPE syndrome criteria (time frame: Once daily until the date that the consecutive 2 cycles of capecitabine-containing chemotherapy ended (up to 6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.