Breast CancerAcubreastNCT00885183
Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy
A study testing Acupuncture therapy in people with Breast Cancer, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acupuncture therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2009to Jun 2014
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease
Who cannot join
- Needle phobia, use of anticoagulant drugs, inability to comply with study regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study
Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Patients diagnosed with cancer frequently seek complementary medicine (CAM), and there is a need to investigate potential effects of CAM therapies. This phased pilot and feasibility study has two aims:
- Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
- Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.
Study results will support the design of future research; including a Phase III randomised controlled trial.
- Conditions
- Breast Cancer
- Being tested
- Acupuncture therapy
- Keywords
- breast cancer, chemotherapy, adjuvant therapy, acupuncture, fatigue, Early stage breast cancer patients
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture therapyProcedure or surgery
12 acupuncture treatment sessions for a period of 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| acupuncture therapy | Experimental | Breast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy Receives: Procedure: Acupuncture therapy |
| Usual care | Other | Control group (usual care) receives standard chemotherapy alone Receives: Procedure: Acupuncture therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue scale
Measured: Weeks 16 and 29
Secondary outcomes (2)
Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw
Measured: Weeks 16, 19 and 29
Hospital anxiety and depression scale (HADS)
Measured: Weeks 16, 19 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2013
- Study completionJun 2014
Why it stopped: Difficult to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society
- Responsible party
- Sponsor
- Investigators
- Sameline Grimsgaard, MD, MPH, PhD, Principal investigator, Clinical Research Centre, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885183
- Sponsor's protocol ID
- REK NORD 77/08
- Acronym
- Acubreast
- Status last verified
- Jun 2019
- First submitted
- 19 Apr 2009
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy. A Randomised Controlled Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT00885183
- Acronym / sponsor ID
- Acubreast / REK NORD 77/08
- Conditions
- Breast Cancer
- Keywords
- breast cancer, chemotherapy, adjuvant therapy, acupuncture, fatigue, Early stage breast cancer patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult to recruit participants
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society
- Study start
- Apr 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Apr 2009 (estimated)
- 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.
Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Patients diagnosed with cancer frequently seek complementary medicine (CAM), and there is a need to investigate potential effects of CAM therapies. This phased pilot and feasibility study has two aims:
- Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
- Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.
Study results will support the design of future research; including a Phase III randomised controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture therapy | Experimental | Procedure: Acupuncture therapyBreast cancer patients are randomised to additional 12 acupuncture treatment sessions while undergoing standard chemotherapy |
| Usual care | Other | Procedure: Acupuncture therapyControl group (usual care) receives standard chemotherapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease
Key exclusion criteria (1 listed)
- Needle phobia, use of anticoagulant drugs, inability to comply with study regimen
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 |
|---|---|---|
| Acupuncture therapy12 acupuncture treatment sessions for a period of 16 weeks | Procedure or surgery | Usual care, acupuncture therapy |
Primary outcome
Fatigue scale
Time frame: Weeks 16 and 29
2 secondary outcomes
Health related quality of life: EORTC QLQ-C30, EORTC QLQ-BR23, MYCaw
Time frame: Weeks 16, 19 and 29
Hospital anxiety and depression scale (HADS)
Time frame: Weeks 16, 19 and 29
Results and safety
The study was stopped early (reason given: Difficult to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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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.
Sameline Grimsgaard, MD, MPH, PhD principal investigator
Clinical Research Centre, University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture therapy in people with Breast Cancer, run by University Hospital of North Norway at 1 site in Norway.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Difficult to recruit participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue scale (time frame: Weeks 16 and 29). 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 1 Jul 2019.