CapecitabineNCT06602167
Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome
A study testing True electroacupuncture + True self-administered acupressure and Doctor-prescribed treatment in people with Capecitabine and Hand-foot Syndrome, run by Affiliated Hospital of Qinghai University at 1 site in China.
Trial summary
This study hypothesizes that electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment is effective in preventing Hand-Foot Syndrome (HFS) caused by capecitabine. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Capecitabine, Hand-foot Syndrome, Electroacupuncture
- What is being tested?
- True electroacupuncture + True self-administered acupressure and Doctor-prescribed treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form;
- Male or female ≥ 18 years old;
- Patients with gastrointestinal cancer or breast cancer who are diagnosed with cancer by pathology will receive capecitabine treatment for the first time according to the label;
- The performance status of the Eastern Cancer Collaboration Group is 0-2;
- Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg/m^2);
- Expected lifespan ≥ 3 months;
- Laboratory requirements: platelet count ≥ 100 × 10^9/L, white blood cell count\>3.0 × 10^9/L, hemoglobin ≥ 10.0 g/dL, normal liver and kidney function;
- Adequate contraception.
Who cannot join
- Previous use of capecitabine or liposome doxorubicin or any other tyrosine kinase inhibitor that may induce HFS (such as sorafenib, sunitinib, and apatinib) for chemotherapy;
- The initial dose of capecitabine is less than 800mg/m^2;
- Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;
- Skin diseases that may interfere with clinical trial results;
- Known drug/alcohol abuse;
- Pregnant women or lactating patients;
Show all 11Show fewer
- Participate in another clinical trial and the patient has received the investigational drug within the last 30 days prior to the start of treatment (i.e. follow-up in the previous trial was not exclusive);
- Known patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles or any component of capecitabine;
- Receive any acupuncture and moxibustion treatment ,there is lymphedema in the area stimulated by acupuncture;
- Patients with any chemotherapy- or radiotherapy-related toxicities that have not subsided to grade 2 or lower will be excluded, except for stable sensory neuropathy.
- Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss, will also be grounds for exclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
13327661976, jiudazhao@126.com
About this study
Official title: Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial
This study hypothesizes that electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment is effective in preventing Hand-Foot Syndrome (HFS) caused by capecitabine. It aims to explore the effectiveness of this combined approach in preventing HFS in patients with malignant tumors undergoing oral capecitabine treatment. Further exploration of prevention and treatment methods may enhance the quality of life for patients during the treatment process.
Read the detailed description
This study is a parallel-group, blinded (blinding applies to participants, evaluators, investigators, and statisticians) randomized controlled trial designed to explore the preventive effect of electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment on HFS in patients with malignant tumors receiving oral capecitabine and to improve the quality of life for patients during treatment. Participants are randomly assigned to one of two groups: a true electroacupuncture combined with true self-administered acupressure group, or a sham electroacupuncture combined with sham self-administered acupressure group. The true electroacupuncture combined with true self-administered acupressure group receives true electroacupuncture combined with true self-administered acupressure plus doctor-prescribed treatment(oral administration of celecoxib, external application of diclofenac, and other skin protectants). The sham electroacupuncture combined with sham self-administered acupressure group receives sham electroacupuncture combined with sham self-administered acupressure plus the same doctor-prescribed treatment. HFS will be assessed following the initiation of capecitabine treatment, with records kept of the capecitabine dosage, the severity of HFS, onset time, and duration of symptoms. In addition, the HFS-14 questionnaire was used to assess the condition of patients at each cycle.
- Conditions
- Capecitabine, Hand-foot Syndrome, Electroacupuncture, Self-administered Acupressure, Breast Cancer, Gastrointestinal Cancers
- Being tested
- True electroacupuncture + True self-administered acupressure, Doctor-prescribed treatment, Sham electroacupuncture + Sham self-administered acupressure
- Keywords
- electroacupuncture, capecitabine, self-administered acupressure, Hand-foot syndrome, Breast cancer, Gastrointestinal cancers
- Medical subject headings
- Hand-Foot Syndrome, Breast Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True electroacupuncture + True self-administered acupressureCombination product
True electroacupuncture: Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi" is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2Hz for 30 minutes. True self-administered acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes.
Doctor-prescribed treatmentDrug
Doctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants.
Sham electroacupuncture + Sham self-administered acupressureCombination product
Sham electroacupuncture: The sham electroacupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi" sensation. Sham self-administered acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi".
| Study group | Role | What they receive |
|---|---|---|
| True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group | Experimental | True electroacupuncture: Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi" is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2Hz for 30 minutes. True self-administered acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes. Doctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants. Receives: Combination Product: True electroacupuncture + True self-administered acupressure; Drug: Doctor-prescribed treatment |
| Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group | Sham comparator | Sham electroacupuncture: The sham electroacupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi" sensation. Sham self-administered acupressure: administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi". Doctor-prescribed treatment: All the drugs used are the same as those in the experimental group. Receives: Drug: Doctor-prescribed treatment; Combination Product: Sham electroacupuncture + Sham self-administered acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFS incidence rate (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS.
Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living.
The more severe the grade, the more it affects the quality of life of patients.
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
Secondary outcomes (9)
The incidence of HFS grade 2-3 (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS.
Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; ; limiting self-care activities of daily living.
The more severe the grade, the more it affects the quality of life of patients.
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
The occurrence time of grade 1-3 HFS (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS.
Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living.
The more severe the grade, the more it affects the quality of life of patients.
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
The occurrence time of grade 2-3 HFS (Compare the difference between the two groups)
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS.
Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living.
The more severe the grade, the more it affects the quality of life of patients.
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
The difference in duration (weeks) of grade 1 to 3 HFS between the two groups
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS.
Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living.
The more severe the grade, the more it affects the quality of life of patients.
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
The difference in duration (weeks) of grade 2 to 3 HFS between the two groups
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS.
Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living.
The more severe the grade, the more it affects the quality of life of patients.
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
The time when pain/sensory abnormalities occur (Compare the difference between the two groups)
The time when pain/sensory abnormalities occur
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
Correlation between capecitabine dose and HFS grade
The correlation between the dose of capecitabine used by the patient and the grade of HFS was recorded.
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
The dependence of electroacupuncture and self-acupoint acupressure treatment in experimental group and control group
Rate of adherence to electroacupuncture therapy in experimental and control groups
Measured: Capecitabine started treatment until 12 weeks after the end of treatment
Changes in patient reported results and adverse events using the HSF-14 (Hand-Foot Syndrome-14) scale from baseline to the end of the study
The HSF-14 (Hand-Foot Syndrome-14) scale is a tool used to evaluate the severity of symptoms and their impact on quality of life in patients with HFS. A total of 14 items are included. Each item was scored on a three-point Likert scale: 0, "no, never"; 1, "yes, from time to time"; 2, "yes, always." Two separate questions were also added, one to measure limb involvement (type of limb affected by HFS, one or both) and one to measure pain. The limb involvement item was scored either 1if only the hands or feet were affected or 3 if both the hands andfeet were affected. The pain item was scored on a three-point scale: 1, not painful; 2, moderately painful; 3, very painful. The total HFS-14 score was calculated by summing the scores of all items and was adjusted to 100 by applying a rule of three. HFS-14 scores were in the range of 2-100, with the higher the score, the greater the quality of life impairment. For details, see PMCID: PMC3228077.
Measured: From the beginning to the end of capecitabine treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start8 Oct 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CapecitabineStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602167
- Sponsor's protocol ID
- AHQU-2024001
- Status last verified
- Dec 2024
- First submitted
- 13 Sep 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06602167
- Acronym / sponsor ID
- AHQU-2024001
- Conditions
- Capecitabine, Hand-foot Syndrome, Electroacupuncture, Self-administered Acupressure, Breast Cancer, Gastrointestinal Cancers
- Keywords
- electroacupuncture, capecitabine, self-administered acupressure, Hand-foot syndrome, Breast cancer, Gastrointestinal cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
This study hypothesizes that electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment is effective in preventing Hand-Foot Syndrome (HFS) caused by capecitabine. It aims to explore the effectiveness of this combined approach in preventing HFS in patients with malignant tumors undergoing oral capecitabine treatment. Further exploration of prevention and treatment methods may enhance the quality of life for patients during the treatment process.
Detailed description
This study is a parallel-group, blinded (blinding applies to participants, evaluators, investigators, and statisticians) randomized controlled trial designed to explore the preventive effect of electroacupuncture combined with self-administered acupressure plus doctor-prescribed treatment on HFS in patients with malignant tumors receiving oral capecitabine and to improve the quality of life for patients during treatment. Participants are randomly assigned to one of two groups: a true electroacupuncture combined with true self-administered acupressure group, or a sham electroacupuncture combined with sham self-administered acupressure group. The true electroacupuncture combined with true self-administered acupressure group receives true electroacupuncture combined with true self-administered acupressure plus doctor-prescribed treatment(oral administration of celecoxib, external application of diclofenac, and other skin protectants). The sham electroacupuncture combined with sham self-administered acupressure group receives sham electroacupuncture combined with sham self-administered acupressure plus the same doctor-prescribed treatment. HFS will be assessed following the initiation of capecitabine treatment, with records kept of the capecitabine dosage, the severity of HFS, onset time, and duration of symptoms. In addition, the HFS-14 questionnaire was used to assess the condition of patients at each cycle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group | Experimental | Combination Product: True electroacupuncture + True self-administered acupressure, Drug: Doctor-prescribed treatmentTrue electroacupuncture: Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi" is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2Hz for 30 minutes. True self-administered acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes. Doctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants. |
| Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group | Sham comparator | Drug: Doctor-prescribed treatment, Combination Product: Sham electroacupuncture + Sham self-administered acupressureSham electroacupuncture: The sham electroacupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi" sensation. Sham self-administered acupressure: administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi". Doctor-prescribed treatment: All the drugs used are the same as those in the experimental group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sign a written informed consent form;
- Male or female ≥ 18 years old;
- Patients with gastrointestinal cancer or breast cancer who are diagnosed with cancer by pathology will receive capecitabine treatment for the first time according to the label;
- The performance status of the Eastern Cancer Collaboration Group is 0-2;
- Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg/m^2);
Key exclusion criteria (11 listed)
- Previous use of capecitabine or liposome doxorubicin or any other tyrosine kinase inhibitor that may induce HFS (such as sorafenib, sunitinib, and apatinib) for chemotherapy;
- The initial dose of capecitabine is less than 800mg/m^2;
- Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;
- Skin diseases that may interfere with clinical trial results;
- Known drug/alcohol abuse;
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 |
|---|---|---|
| True electroacupuncture + True self-administered acupressureTrue electroacupuncture: Participants will receive two electroacupuncture treatments within the first week of each treatment cycle. The acupuncturist inserts the needle into the point and manipulates the needle until the feeling of "deqi" is achieved and reported by the participant. The electrical stimulation will be administered at a sustained frequency of 2Hz for 30 minutes. True self-administered acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes. | Combination product | True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group |
| Doctor-prescribed treatmentDoctor-prescribed treatment: At the beginning of capecitabine, patients will be treated with doctor-recommended medications, including oral celecoxib, topical diclofenac, and other skin protectants. | Drug | Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group, True electroacupuncture + True self-administered acupressure plus doctor-prescribed treatment group |
| Sham electroacupuncture + Sham self-administered acupressureSham electroacupuncture: The sham electroacupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive acupuncture treatment without electrical stimulation same the intervention group. And avoid "deqi" sensation. Sham self-administered acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi". | Combination product | Sham electroacupuncture + sham self-administered acupressure plus doctor-prescribed treatment group |
Primary outcome
HFS incidence rate (Compare the difference between the two groups)
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
The clinician evaluated the patient's HFS grade according to the NCI CTCAEv5.0 grading for HFS. Grade 1: Minimal skin changes or dermatitis (eg, erythema, oedema, or hyperkeratosis) without pain； Grade 2: Skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting instrumental activities of daily living; Garde 3: Severe skin changes (eg, peeling, blisters, bleeding, oedema, or hyperkeratosis) with pain; limiting self-care activities of daily living. The more severe the grade, the more it affects the quality of life of patients.
9 secondary outcomes
The incidence of HFS grade 2-3 (Compare the difference between the two groups)
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
The occurrence time of grade 1-3 HFS (Compare the difference between the two groups)
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
The occurrence time of grade 2-3 HFS (Compare the difference between the two groups)
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
The difference in duration (weeks) of grade 1 to 3 HFS between the two groups
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
The difference in duration (weeks) of grade 2 to 3 HFS between the two groups
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
The time when pain/sensory abnormalities occur (Compare the difference between the two groups)
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
Correlation between capecitabine dose and HFS grade
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
The dependence of electroacupuncture and self-acupoint acupressure treatment in experimental group and control group
Time frame: Capecitabine started treatment until 12 weeks after the end of treatment
Changes in patient reported results and adverse events using the HSF-14 (Hand-Foot Syndrome-14) scale from baseline to the end of the study
Time frame: From the beginning to the end of capecitabine treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True electroacupuncture + True self-administered acupressure and Doctor-prescribed treatment in people with Capecitabine and Hand-foot Syndrome, run by Affiliated Hospital of Qinghai University at 1 site in China.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiuda Zhao (869716230893, jiudazhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFS incidence rate (Compare the difference between the two groups) (time frame: Capecitabine started treatment until 12 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2024.