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

The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery: Pragmatic Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms; Acupuncture Therapy
• Intervention / Treatment: Other: Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carles Fernández, Phusical Terapist; Phone Number: 0034651503494; Email: carlesfj@blanquerna.url.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture group; 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.	Other: Acupuncture; Treatment of disease by inserting needles along specific pathways or meridians. The placement varies with the disease being treated. It is sometimes used in conjunction with heat, moxibustion, acupressure, or electric stimulation.
NO_INTERVENTION: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-intervention pain at 12 hours after surgery	Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.	12 hours after surgery (before the acupuncture treatment)
Post-intervention pain at 48 hours after surgery	Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.	48 hours after surgery (after the acupuncture treatment)
Post-intervention pain at first out-patient visit	Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.	In the first out-patient visit between 10 and 12 days after the intervention (evaluated before the acupuncture session)
Analgesic compsumption during hospital stay	Amount of analgesic medication administered (ex: mg)	During the hospital stay
Analgesic compsumption at home	Amount of analgesic medication administered (ex: mg)	From discharge until day 15 after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety at 12 hours	Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition.	Evaluations will be made 12 hours after the intervention
Anxiety at 48 hours	Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition.	Evaluations will be made 48 hours after the intervention
Anxiety at first visit	Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition	Evaluations will be made at first visit, between 10 and 12 days after the intervention.
Anxiety at one month	Anxiety will be evaluated by the Spanish version of the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). This scale has a score between 0 and 21 for either anxiety or depression with greater punctuation indicating a worse condition.	Evaluations will be made at one month after surgery.
Postoperative nausea after surgery	The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)	At 12 hours after surgery
Postoperative nausea at 24-48 hours	The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)	At 24-48 hours after surgery
Post-operative complications	Post-operative complications such as seroma, infection and wound healing will be recorded.	Up to one month.
Acupuncture adverse events	Adverse events possibly linked to acupuncture such as pain, hematomas etc. will be recorded.	Up to one month.

Collaborators and Investigators

• Sponsor: University Ramon Llull
• Collaborators: Hospital Quiron Sagrado Corazon

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (ACTUAL): October 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 001 (NavyGHB); 2019/59-FIS-HUSC (OTHER: Hospital Sagrado Corazón)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No