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

Overview

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.

Interventions

• Combination product True electroacupuncture + True self-administered acupressure
  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-administe
• Drug Doctor-prescribed treatment
  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.
• Combination product Sham electroacupuncture + Sham self-administered acupressure
  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: Ad

Primary outcome measures

• HFS incidence rate (Compare the difference between the two groups) [Time frame: Capecitabine started treatment until 12 weeks after the end of treatment]

Secondary outcome measures (9)

• The incidence of HFS grade 2-3 (Compare the difference between the two groups) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: Capecitabine started treatment until 12 weeks after the end of treatment]
• Correlation between capecitabine dose and HFS grade [Time frame: 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 [Time frame: 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 [Time frame: From the beginning to the end of capecitabine treatment]

Eligibility criteria

Inclusion criteria

• Sign a written informed consent form;
• Male or female ≥ 18 years old;
• 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;
• The performance status of the Eastern Cancer Collaboration Group is 0-2;
• Palliative or adjuvant chemotherapy with capecitabine (combination or monotherapy, minimum daily total dose of capecitabine 2000 mg/m\^2);
• Expected lifespan ≥ 3 months;
• 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;
• Adequate contraception.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Qinghai University Affiliated Hospital — Xining

Identifiers

NCT: NCT06602167 · AHQU-2024001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗