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
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Ramon Llull | Hospital Quiron Sagrado Corazon |
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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