Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT06602167
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06602167
Study Brief:
Protocol Section:
NCT06602167