Acupuncture TherapyNCT04608175
The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery
A study testing Acupuncture in people with Acupuncture Therapy and Breast Neoplasms, run by University Ramon Llull.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Acupuncture Therapy, Breast Neoplasms
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Acupuncture Therapy, Breast Neoplasms
- Being tested
- Acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | The experimental group will receive the standard treatment administered in these cases (analgesic regimen and nursing care procedures), in addition to the following acupuncture therapy.
In the first visit (preoperative), the anamnesis and energy diagnosis of each patient will be carried out following the practices of Traditional Chinese Medicine (TCM) to design a personalized treatment based on the patient's medical history. A treatment of approximately 10 to 12 acupuncture points will be designed considering the TCM diagnosis and medical history of each patient. Both TCM diagnosis and the points used will be reassessed in each session. The points belonging to the upper extremity of the affected breast will be treated on the contralateral side, taking care not to insert any needle in the limb on the affected side. No points in the operated region will be used. Receives: Other: Acupuncture |
| Control group | No intervention | The control group will only receive standard care procedures (analgesic regimen and nursing care procedures), although they will have the same follow up visits as the patients in the intervention group to facilitate analysis of the study variables. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours after surgery (before the acupuncture treatment)
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.
Measured: 48 hours after surgery (after the acupuncture treatment)
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.
Measured: In the first out-patient visit between 10 and 12 days after the intervention (evaluated before the acupuncture session)
Analgesic compsumption during hospital stay
Amount of analgesic medication administered (ex: mg)
Measured: During the hospital stay
Analgesic compsumption at home
Amount of analgesic medication administered (ex: mg)
Measured: From discharge until day 15 after surgery.
Secondary outcomes (8)
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.
Measured: Evaluations will be made 12 hours after the intervention
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.
Measured: Evaluations will be made 48 hours after the intervention
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
Measured: Evaluations will be made at first visit, between 10 and 12 days after the intervention.
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.
Measured: Evaluations will be made at one month after surgery.
Postoperative nausea after surgery
The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)
Measured: At 12 hours after surgery
Postoperative nausea at 24-48 hours
The intensity of postoperative nausea will also be evaluated by the numerical rating scale (NRS)
Measured: At 24-48 hours after surgery
Post-operative complications
Post-operative complications such as seroma, infection and wound healing will be recorded.
Measured: Up to one month.
Acupuncture adverse events
Adverse events possibly linked to acupuncture such as pain, hematomas etc. will be recorded.
Measured: Up to one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Quiron Sagrado Corazon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608175
- Sponsor's protocol ID
- 001
- Other IDs
- 2019/59-FIS-HUSC
- Status last verified
- Sep 2020
- First submitted
- 9 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery: Pragmatic Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04608175
- Acronym / sponsor ID
- 001
- Conditions
- Acupuncture Therapy, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Collaborators
- Hospital Quiron Sagrado Corazon
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: AcupunctureThe experimental group will receive the standard treatment administered in these cases (analgesic regimen and nursing care procedures), in addition to the following acupuncture therapy. In the first visit (preoperative), the anamnesis and energy diagnosis of each patient will be carried out following the practices of Traditional Chinese Medicine (TCM) to design a personalized treatment based on the patient's medical history. A treatment of approximately 10 to 12 acupuncture points will be designed considering the TCM diagnosis and medical history of each patient. Both TCM diagnosis and the points used will be reassessed in each session. The points belonging to the upper extremity of the affected breast will be treated on the contralateral side, taking care not to insert any needle in the limb on the affected side. No points in the operated region will be used. |
| Control group | No intervention | –The control group will only receive standard care procedures (analgesic regimen and nursing care procedures), although they will have the same follow up visits as the patients in the intervention group to facilitate analysis of the study variables. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureTreatment 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. | Other | Acupuncture group |
Primary outcome
Post-intervention pain at 12 hours after surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the hospital stay
Amount of analgesic medication administered (ex: mg)
Analgesic compsumption at home
Time frame: From discharge until day 15 after surgery.
Amount of analgesic medication administered (ex: mg)
8 secondary outcomes
Anxiety at 12 hours
Time frame: Evaluations will be made 12 hours after the intervention
Anxiety at 48 hours
Time frame: Evaluations will be made 48 hours after the intervention
Anxiety at first visit
Time frame: Evaluations will be made at first visit, between 10 and 12 days after the intervention.
Anxiety at one month
Time frame: Evaluations will be made at one month after surgery.
Postoperative nausea after surgery
Time frame: At 12 hours after surgery
Postoperative nausea at 24-48 hours
Time frame: At 24-48 hours after surgery
Post-operative complications
Time frame: Up to one month.
Acupuncture adverse events
Time frame: Up to one month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture Therapy and Breast Neoplasms, run by University Ramon Llull.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carles Fernández, Phusical Terapist (0034651503494, carlesfj@blanquerna.url.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention pain at 12 hours after surgery (time frame: 12 hours after surgery (before the acupuncture treatment)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.