Acupuncture Therapy, Breast Neoplasms
Conditions
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.
Interventions
OTHERAcupuncture
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.
Sponsors
Hospital Quiron Sagrado Corazon
University Ramon Llull
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-intervention pain at 12 hours after surgery | 12 hours after surgery (before the acupuncture treatment) | 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. |
| Post-intervention pain at 48 hours after surgery | 48 hours after surgery (after the acupuncture treatment) | 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. |
| Post-intervention pain at first out-patient visit | In the first out-patient visit between 10 and 12 days after the intervention (evaluated before the acupuncture session) | 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. |
| Analgesic compsumption during hospital stay | During the hospital stay | Amount of analgesic medication administered (ex: mg) |
| Analgesic compsumption at home | From discharge until day 15 after surgery. | Amount of analgesic medication administered (ex: mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea at 24-48 hours | At 24-48 hours after surgery | The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS) |
| Anxiety at 12 hours | Evaluations will be made 12 hours after the intervention | 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. |
| Acupuncture adverse events | Up to one month. | Adverse events possibly linked to acupuncture such as pain, hematomas etc. will be recorded. |
| Post-operative complications | Up to one month. | Post-operative complications such as seroma, infection and wound healing will be recorded. |
| Anxiety at 48 hours | Evaluations will be made 48 hours after the intervention | 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. |
| Anxiety at first visit | Evaluations will be made at first visit, between 10 and 12 days after the intervention. | 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 |
| Anxiety at one month | Evaluations will be made at one month after surgery. | 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. |
| Postoperative nausea after surgery | At 12 hours after surgery | The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS) |
Contacts
Primary ContactCarles Fernández, Phusical Terapist
Outcome results
None listed