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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094310
• Other study ID #: AHQU-2021007
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2022
• Source: Affiliated Hospital of Qinghai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Qinghai University Affiliated Hospital	Xining	Qinghai

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Qinghai University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of BFI score change after treatment	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).	2 years
Secondary	Side effects related to electroacupuncture	Side effects related to electroacupuncture	2 years