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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| True electroacupuncture + True self-administered acupressure | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Capecitabine started treatment until 12 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiuda Zhao | Contact | 869716230893 | jiudazhao@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qinghai University Affiliated Hospital | Recruiting | Xining | Qinghai | 810000 | China |
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| Doctor-prescribed treatment | Drug | 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. |
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| Sham electroacupuncture + Sham self-administered acupressure | Combination 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". |
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| 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. | 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. | 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. | 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. | 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 | 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. | 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 | 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. | From the beginning to the end of capecitabine treatment |
| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| D001943 | Breast Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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