The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery

University Ramon Llull

Status: Unknown

Conditions: Breast Neoplasms; Acupuncture Therapy

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04608175

001

2019/59-FIS-HUSC (Other Identifier)

Details and patient eligibility

About

Background: Breast cancer is one of the most prevalent cancers worldwide. Fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. However, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy.

Methods: This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain). A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications.

Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of breast cancer
• Primary breast cancer patient
• Candidate for breast cancer surgery (mastectomy)
• Aged between 20 and 70 years old
• Consenting to participate in the study and signing the informed consent form.

Exclusion criteria

• Have a previous history of breast cancer
• Have a previous diagnosis of a severe psychiatric disorder
• Present risk factors associated with breast cancer
• Do not speak Spanish or Catalan
• Are currently participating in another trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Acupuncture group

Experimental group

Description:

The experimental group will receive the standard treatment administered in these cases (analgesic regimen and nursing care procedures), in addition to the following acupuncture therapy. In the first visit (preoperative), the anamnesis and energy diagnosis of each patient will be carried out following the practices of Traditional Chinese Medicine (TCM) to design a personalized treatment based on the patient's medical history. A treatment of approximately 10 to 12 acupuncture points will be designed considering the TCM diagnosis and medical history of each patient. Both TCM diagnosis and the points used will be reassessed in each session. The points belonging to the upper extremity of the affected breast will be treated on the contralateral side, taking care not to insert any needle in the limb on the affected side. No points in the operated region will be used.

Treatment:

Other: Acupuncture

Control group

No Intervention group

Description:

The control group will only receive standard care procedures (analgesic regimen and nursing care procedures), although they will have the same follow up visits as the patients in the intervention group to facilitate analysis of the study variables.