Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome

Launched by AFFILIATED HOSPITAL OF QINGHAI UNIVERSITY · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether a combination of electroacupuncture and self-administered acupressure can help prevent Hand-Foot Syndrome (HFS), a painful condition that can occur with the use of the cancer medication capecitabine. The study aims to see if this approach, alongside standard medical treatments, can improve the quality of life for patients with breast cancer or gastrointestinal cancers who are starting capecitabine for the first time.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with breast or gastrointestinal cancer. They should be receiving capecitabine for the first time and meet certain health criteria, such as having a good performance status and normal blood counts. Participants can expect to receive treatments and be monitored for any changes in their condition. It's important to note that there are some criteria that would exclude individuals from joining, such as previous treatments that might interfere with the study or certain medical conditions. Overall, this trial aims to offer new ways to help patients manage side effects during their cancer treatment.

Gender

ALL

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\>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.