Clinical trial NCT04608175: The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery
Official title: The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery: Pragmatic Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture Therapy
Breast Neoplasms
Lead sponsor: University Ramon Llull
Sponsor class: OTHER
Collaborators: name: Hospital Quiron Sagrado Corazon
First posted: 2020-10-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-intervention pain at 12 hours after surgery
timeFrame: 12 hours after surgery (before the acupuncture treatment)
measure: Post-intervention pain at 48 hours after surgery
timeFrame: 48 hours after surgery (after the acupuncture treatment)
measure: Post-intervention pain at first out-patient visit
timeFrame: In the first out-patient visit between 10 and 12 days after the intervention (evaluated before the acupuncture session)
measure: Analgesic compsumption during hospital stay
timeFrame: During the hospital stay
measure: Analgesic compsumption at home
timeFrame: From discharge until day 15 after surgery.
Secondary outcomes:
measure: Anxiety at 12 hours
timeFrame: Evaluations will be made 12 hours after the intervention
measure: Anxiety at 48 hours
timeFrame: Evaluations will be made 48 hours after the intervention
measure: Anxiety at first visit
timeFrame: Evaluations will be made at first visit, between 10 and 12 days after the intervention.
measure: Anxiety at one month
timeFrame: Evaluations will be made at one month after surgery.
measure: Postoperative nausea after surgery
timeFrame: At 12 hours after surgery
measure: Postoperative nausea at 24-48 hours
timeFrame: At 24-48 hours after surgery
measure: Post-operative complications
timeFrame: Up to one month.
measure: Acupuncture adverse events
timeFrame: Up to one month.
Other outcomes:
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