Clinical trial NCT06602167: Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome
Official title: Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Sign a written informed consent form;
2. Male or female ≥ 18 years old;
3. 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;
4. The performance status of the Eastern Cancer Collaboration Group is 0-2;
5. Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg/m\^2);
6. Expected lifespan ≥ 3 months;
7. Laboratory requirements: platelet count ≥ 100 × 10\^9/L, white blood cell count\&amp;amp;gt;3.0 × 10\^9/L, hemoglobin ≥ 10.0 g/dL, normal liver and kidney function;
8. Adequate contraception.

Exclusion Criteria:

1. 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;
2. The initial dose of capecitabine is less than 800mg/m\^2;
3. Radiation therapy or surgery should be performed within 4 weeks before the start of treatment;
4. Skin diseases that may interfere with clinical trial results;
5. Known drug/alcohol abuse;
6. Pregnant women or lactating patients;
7. 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);
8. Known patients who are afraid of electroacupuncture stimulation or allergic to stainless steel needles or any component of capecitabine;
9. Receive any acupuncture and moxibustion treatment ,there is lymphedema in the area stimulated by acupuncture;
10. 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.
11. Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss, will also be grounds for exclusion.

Primary outcomes:
measure: HFS incidence rate (Compare the difference between the two groups)
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
Secondary outcomes:
measure: The incidence of HFS grade 2-3 (Compare the difference between the two groups)
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: The occurrence time of grade 1-3 HFS (Compare the difference between the two groups)
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: The occurrence time of grade 2-3 HFS (Compare the difference between the two groups)
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: The difference in duration (weeks) of grade 1 to 3 HFS between the two groups
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: The difference in duration (weeks) of grade 2 to 3 HFS between the two groups
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: The time when pain/sensory abnormalities occur (Compare the difference between the two groups)
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: Correlation between capecitabine dose and HFS grade
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: The dependence of electroacupuncture and self-acupoint acupressure treatment in experimental group and control group
timeFrame: Capecitabine started treatment until 12 weeks after the end of treatment
measure: 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
timeFrame: From the beginning to the end of capecitabine treatment
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
Study officials:
References: