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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: Acupuncture

• Registration Number: NCT05094310
• Lead Sponsor: Affiliated Hospital of Qinghai University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-10-26
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-27
• Study Start: 2022-04-01
• Last Update Posted: 2022-04-06
• Primary Completion: 2022-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture group	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Difference of BFI score change after treatment	2 years	Brief Fatigue Inventory（ BFI）is a nine item scale used to evaluate the intensity of fatigue and the interference of fatigue to normal activities. The classification of fatigue severity is: Mild fatigue (1-3), Moderate fatigue (4-6) and Severe fatigue (7-10).

Secondary Outcome Measures

Name	Time	Method
Side effects related to electroacupuncture	2 years	Side effects related to electroacupuncture

Trial Locations

Locations (1)

Qinghai University Affiliated Hospital; 🇨🇳 Xining, Qinghai, China