Study on the Impact of Electroacupuncture Combined With Self-Acupressure on the Quality of Life of Patients With Early-Stage Breast Cancer Undergoing Chemotherapy

NCT06601621 | Recruiting DMC

• 1 other identifier: AHQU-2024002
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate the effect of electroacupuncture combined with self-acupressure on the quality of life of early-stage breast cancer patients receiving chemotherapy.

Conditions

Electroacupuncture; Quality of Life (QOL); Acupressure; Breast Cancer; Chemotherapy

Keywords

electroacupuncture; self-acupressure; Quality of life (QOL); breast cancer

Outcome Measures

Primary Outcomes (1)

• Differences in quality of life during the overall stage

  Difference in change in EQ-5D-5L scores from first to last assessment between two arms

  Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

Secondary Outcomes (3)

• Differences in quality of life during the overall stage

  Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

• Changes in scores on the five dimensions of the EQ-5D-5L

  Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

• Changes in the dimensions of the FACT-B scale

  Chemotherapy treatment was initiated to 21 days after the last chemotherapy cycle

Study Arms (2)

True electroacupuncture + True self-acupressure

EXPERIMENTAL

Participants will receive two electroacupuncture treatments during the first week of the chemotherapy cycle. The acupuncturist will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. Electrical stimulation will be delivered for 30 minutes at alternating frequencies of 2/10Hz. Participants will do acupressure daily during the second week of the chemotherapy cycle (two weeks for one chemotherapy cycle) or the second and third weeks (three weeks for one chemotherapy cycle). participants performed true self-acupressure, pressing each acupoint with their thumb to achieve "deqi" for three minutes.

Combination Product: electroacupuncture+ self-acupressure

Sham electroacupuncture + Sham self-acupressure

PLACEBO COMPARATOR

The sham acupuncture is the use 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 minimal acupuncture treatment without electrical stimulation at the same time as the intervention group. Care was taken to avoid "de qi" sensation. Sham self-acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi".

Combination Product: sham electroacupuncture + sham self-acupressure

Interventions

electroacupuncture+ self-acupressure COMBINATION_PRODUCT

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 2/10Hz for 30 minutes. self-acupressure: In weeks 2 and 3 of each treatment cycle, participants performed true self-administered acupressure, pressing each acupoint with their thumb to achieve "deqi"; for three minutes.

True electroacupuncture + True self-acupressure

sham electroacupuncture + sham self-acupressure COMBINATION_PRODUCT

Sham electroacupuncture: The sham electroacupuncture 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-acupressure: Administered non-acupressure points 1 to 3cm away from the true acupressure points used in the experimental group and away from known meridians. The frequency, course duration, and overall treatment time will be the same as those in the true self-administered shiatsu group. The applied pressure does not cause a feeling of "deqi".

Sham electroacupuncture + Sham self-acupressure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older and aged 75 years or younger, inclusive. with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Patients who have not received prior chemotherapy and are scheduled to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy or combination targeted therapy;
• Normal organ function with platelets ≥ 100\*10\^9/ L, hemoglobin ≥ 90 g/L, serum creatinine ≤ 1.5 mg/dl (133 mmol/L), or creatinine clearance ≥ 60 ml/min, total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase ≤ 2.5 times ULN, and aspartate aminotransferase ≤ 2.5 times ULN;
• Premenopausal women need appropriate contraception;
• Ability to understand the study well and complete the study questionnaire.

You may not qualify if:

• Patients with needle phobia or allergy to stainless steel needles; and
• Current diagnosis of mental illness (e.g., major depression, obsessive-compulsive disorder, or schizophrenia);
• History of autoimmune diseases, blood disorders, or organ transplantation, or long-term use of hormones or immunosuppressants;
• Comorbid bleeding disorders or thyroid dysfunction;
• Implantation of a pacemaker; pregnancy or breastfeeding;
• A plan for adjuvant radiotherapy in the upcoming chemotherapy cycle;
• Current active infection;
• Acupuncture treatment within the last four weeks;
• Patients who are allergic to the drugs used;
• Use of other Traditional Chinese Medicine (TCM) techniques such as Chinese herbs in the next chemotherapy cycle.

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Breast Disease Diagnosis and Treatment Center

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: October 19, 2024
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CN (1)