Genetic Predictors of Response to Acupuncture for Cancer-related Fatigue Among Breast Cancer Patients After Chemotherapy

Affiliated Hospital of Qinghai University

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05094310

AHQU-2021007

Details and patient eligibility

About

Genetic predictors of response to acupuncture for cancer-related fatigue among breast cancer patients after chemotherapy.

Full description

Cancer related fatigue(CRF) in patients with breast cancer has a great impact on their quality of life and treatment compliance. Many studies suggest that acupuncture has certain therapeutic effects on fatigue. In this clinical trial, we treated patients with acupuncture to alleviate their fatigue symptoms. Currently, studies have shown that cancer related fatigue in breast cancer patients is related to some biological factors. While acupuncture is used to treat fatigue, we will collect blood samples from patients for fatigue related single nucleotide polymorphisms（SNP）.

Based on CRF related biological factors, our study aims to screen SNPs that related to CRF related biological factors to guide electroacupuncture in the treatment of cancer-related fatigue and establish a prognostic model.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient was diagnosed with breast cancer.;
2. Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study;
3. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
4. Patients with previous local recurrence were eligible, but not patients with distant metastasis；
5. The basic indexes were consistent, and the blood routine and ECG were normal.

Exclusion criteria

1. The exclusion criteria were patients with needle phobia;
2. Low platelet count (<50 000); co-morbidity with a bleeding disorder; co-morbidity with thyroid dysfunction; pregnancy; haemoglobin levels <10 g/dl and haematocrit <30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids；
3. Life expectancy <6 months；
4. lymphoedematous limbs.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Acupuncture group

Experimental group

Description:

Patients with breast cancer who experienced fatigue were measured by the Brief Fatigue Inventory(BFI) scale and other Fatigue related questionnaire. Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study，and those patients will receive acupuncture treatment. The position of acupuncture refers to the principle of acupuncture treatment of traditional Chinese medicine. According to ICD-10-CD code R53.0, the diagnosis of CRF is determined by the experience of diminished energy or other physical and psychological symptoms every day or almost every day for two consecutive weeks in the past month. We collected patients' blood to detect fatigue related SNP.

Treatment:

Device: Acupuncture