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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04608175
• Other study ID #: 001
• Secondary ID: 2019/59-FIS-HUSC
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2020
• Est. completion date: March 2023

Study information

• Verified date: September 2020
• Source: University Ramon Llull
• Contact: Carles Fernández, Phusical Terapist
• Phone: 0034651503494
• Email: carlesfj[@]blanquerna.url.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture Therapy
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Ramon Llull	Hospital Quiron Sagrado Corazon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Analgesic compsumption during hospital stay	Amount of analgesic medication administered (ex: mg)	During the hospital stay
Primary	Analgesic compsumption at home	Amount of analgesic medication administered (ex: mg)	From discharge until day 15 after surgery.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	Postoperative nausea after surgery	The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)	At 12 hours after surgery
Secondary	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
Secondary	Post-operative complications	Post-operative complications such as seroma, infection and wound healing will be recorded.	Up to one month.
Secondary	Acupuncture adverse events	Adverse events possibly linked to acupuncture such as pain, hematomas etc. will be recorded.	Up to one month.