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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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