Using electroacupuncture and acupressure to prevent hand-foot syndrome in breast cancer patients on capecitabine

Electroacupuncture Combined With Self-administered Acupressure for the Prevention of Capecitabine-Associated Hand-Foot Syndrome: a Randomized Controlled Trial

This study is testing if combining electroacupuncture with self-acupressure can help prevent hand-foot syndrome in breast cancer patients taking capecitabine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Affiliated Hospital of Qinghai University (Academic / other)
• Drugs / interventions: sunitinib, apatinib, chemotherapy, Radiation, doxorubicin
• Locations: 1 site (Xining, Qinghai)
• Trial ID: NCT06602167 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of combining electroacupuncture with self-administered acupressure to prevent Hand-Foot Syndrome (HFS) in patients with malignant tumors undergoing treatment with capecitabine. It is a randomized controlled trial where participants are assigned to either a true treatment group or a sham treatment group, both receiving doctor-prescribed care. The study aims to assess the severity and duration of HFS symptoms while enhancing the quality of life for patients during their cancer treatment. The HFS-14 questionnaire will be utilized to evaluate patient conditions throughout the treatment cycles.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with gastrointestinal or breast cancer who are starting capecitabine treatment for the first time.

Not a fit: Patients who have previously received capecitabine or other specific chemotherapy agents that may cause hand-foot syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence and severity of hand-foot syndrome in patients receiving capecitabine, improving their overall treatment experience.

How similar studies have performed: While the combination of electroacupuncture and acupressure is a novel approach, similar studies have shown promise in managing chemotherapy-related side effects.

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.

Where this trial is running

Xining, Qinghai

• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)

Study contacts

• Study coordinator: Jiuda Zhao

Conditions Capecitabine; Hand-foot Syndrome; Electroacupuncture; Self-administered Acupressure; Breast Cancer; Gastrointestinal Cancers; electroacupuncture; capecitabine