Anxiety DisorderPhase 3NCT00957112
Acupuncture or Self-Acupuncture in Managing Cancer-Related Fatigue in Women Who Have Received Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer
A Phase 3 study testing acupuncture therapy and standard follow-up care in people with Anxiety Disorder and Breast Cancer, run by University of Manchester at 1 site in United Kingdom.
Trial summary
RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known whether acupuncture is more effective than self-acupuncture in managing fatigue in women with breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anxiety Disorder, Breast Cancer, Depression
- What is being tested?
- acupuncture therapy and standard follow-up care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2007to Feb 2013
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Stage I, II, or IIIA disease
- Completed prior chemotherapy for ≥ 1 month and up to 5 years
- No needling on the ipsilateral arm of patients who have undergone axillary dissection
- No needling on the lymphedematous limbs
- Score of ≥ 5 on a 0-10 single-item screening fatigue scale, where 0 is no fatigue at all and 10 is extremely fatigued
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 6 months
- Menopausal status not specified
- Platelet count ≥ 50,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Hematocrit ≥ 30%
- Not pregnant
- No needle phobia
- No co-morbidity with any of the following:
- Bleeding disorder
- Thyroid dysfunction
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No planned concurrent chemoradiotherapy
- No concurrent steroids
- No concurrent epoetin alfa or transfusion for anemia
- No other concurrent complementary therapies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Manchester
Manchester, England, M13 9PL
About this study
Official title: The Efficacy of Acupuncture and Self-acupuncture in Managing Cancer-related Fatigue in Breast Cancer Patients: a Pragmatic Randomised Trial
RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known whether acupuncture is more effective than self-acupuncture in managing fatigue in women with breast cancer.
PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared with self-acupuncture in managing cancer-related fatigue in women who have received chemotherapy for stage I, stage II, or stage IIIA breast cancer.
Read the detailed description
OBJECTIVES:
- Assess the efficacy of a course of acupuncture in the management of cancer-related fatigue in a homogeneous sample of women with stage I, II, or IIIA breast cancer who have completed adjuvant chemotherapy.
- Assess the efficacy of self-acupuncture in comparison to therapist-administered acupuncture in sustaining, in the longer term, any effects observed with a 6-week course of acupuncture in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to study center and fatigue score (low vs moderate vs severe). Patients are randomized at 3:1 ratio (arm I: arm II) to 1 of 2 treatment arms.
- Arm I (experimental): Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.
- Arm II (control): Patients undergo standard care. They also receive written information about fatigue as in arm I.
After 6 weeks, patients in arm I are again randomized to 1 of 3 arms.
- Arm A: Patients receive treatment as in arm I for 4 more weeks.
- Arm B: Patients receive treatment as in arm II for 4 more weeks.
- Arm C: Patients learn to self-acupuncture and do so weekly for 4 more weeks. All patients complete questionnaires on fatigue, hospital anxiety and depression, quality of life, and use of complementary therapies at baseline and periodically during study. Patient's sociodemographic and treatment characteristic records are also reviewed.
After completion of study therapy, patients are followed up periodically for 18 weeks.
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Fatigue
- Being tested
- acupuncture therapy, standard follow-up care
- Keywords
- anxiety disorder, depression, fatigue, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture therapyProcedure or surgery
Patients undergo therapist-acupuncture with or without self-acupuncture
standard follow-up careProcedure or surgery
Patients receive standard care
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management. Receives: Procedure: acupuncture therapy |
| Arm II | No intervention | Patients receive standard care. They also receive written information about fatigue as in arm I. Receives: Procedure: standard follow-up care |
| Arm A | Experimental | Patients receive treatment as in arm I for 4 more weeks. Receives: Procedure: acupuncture therapy |
| Arm B | No intervention | Patients receive standard care as in arm II for 4 more weeks. Receives: Procedure: standard follow-up care |
| Arm C | Experimental | Patients learn to self-acupuncture and do so weekly for 4 more weeks. Receives: Procedure: acupuncture therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
General fatigue as measured by the Multidimensional Fatigue Inventory
Secondary outcomes (4)
Mental fatigue as measured by the Multidimensional Fatigue Inventory
Anxiety as measured by the Hospital Anxiety and Depression Scale
Depression as measured by the Hospital Anxiety and Depression Scale
Quality of life as measured by the FACT-G and Breast Cancer module
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Investigators
- Alex Molassiotis, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957112
- Sponsor's protocol ID
- CDR0000649750
- Other IDs
- UM-ASA, EU-20970
- Status last verified
- Aug 2009
- First submitted
- 11 Aug 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder WD, Filshie J, Ream E, Eaton D, Richardson A. A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture. Ann Oncol. 2013 Jun;24(6):1645-52. doi: 10.1093/annonc/mdt034. Epub 2013 Feb 21.
PubMed 23436910Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, Ream E, Richardson A. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol. 2012 Dec 20;30(36):4470-6. doi: 10.1200/JCO.2012.41.6222. Epub 2012 Oct 29.
PubMed 23109700
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Acupuncture and Self-acupuncture in Managing Cancer-related Fatigue in Breast Cancer Patients: a Pragmatic Randomised Trial
- ClinicalTrials.gov ID
- NCT00957112
- Acronym / sponsor ID
- CDR0000649750
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Fatigue
- Keywords
- anxiety disorder, depression, fatigue, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Aug 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.
RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known whether acupuncture is more effective than self-acupuncture in managing fatigue in women with breast cancer.
PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared with self-acupuncture in managing cancer-related fatigue in women who have received chemotherapy for stage I, stage II, or stage IIIA breast cancer.
Detailed description
OBJECTIVES:
- Assess the efficacy of a course of acupuncture in the management of cancer-related fatigue in a homogeneous sample of women with stage I, II, or IIIA breast cancer who have completed adjuvant chemotherapy.
- Assess the efficacy of self-acupuncture in comparison to therapist-administered acupuncture in sustaining, in the longer term, any effects observed with a 6-week course of acupuncture in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to study center and fatigue score (low vs moderate vs severe). Patients are randomized at 3:1 ratio (arm I: arm II) to 1 of 2 treatment arms.
- Arm I (experimental): Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.
- Arm II (control): Patients undergo standard care. They also receive written information about fatigue as in arm I.
After 6 weeks, patients in arm I are again randomized to 1 of 3 arms.
- Arm A: Patients receive treatment as in arm I for 4 more weeks.
- Arm B: Patients receive treatment as in arm II for 4 more weeks.
- Arm C: Patients learn to self-acupuncture and do so weekly for 4 more weeks. All patients complete questionnaires on fatigue, hospital anxiety and depression, quality of life, and use of complementary therapies at baseline and periodically during study. Patient's sociodemographic and treatment characteristic records are also reviewed.
After completion of study therapy, patients are followed up periodically for 18 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: acupuncture therapyPatients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management. |
| Arm II | No intervention | Procedure: standard follow-up carePatients receive standard care. They also receive written information about fatigue as in arm I. |
| Arm A | Experimental | Procedure: acupuncture therapyPatients receive treatment as in arm I for 4 more weeks. |
| Arm B | No intervention | Procedure: standard follow-up carePatients receive standard care as in arm II for 4 more weeks. |
| Arm C | Experimental | Procedure: acupuncture therapyPatients learn to self-acupuncture and do so weekly for 4 more weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 therapyPatients undergo therapist-acupuncture with or without self-acupuncture | Procedure or surgery | Arm A, Arm C, Arm I |
| standard follow-up carePatients receive standard care | Procedure or surgery | Arm B, Arm II |
Primary outcome
General fatigue as measured by the Multidimensional Fatigue Inventory
4 secondary outcomes
Mental fatigue as measured by the Multidimensional Fatigue Inventory
Anxiety as measured by the Hospital Anxiety and Depression Scale
Depression as measured by the Hospital Anxiety and Depression Scale
Quality of life as measured by the FACT-G and Breast Cancer module
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 23436910Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder WD, Filshie J, Ream E, Eaton D, Richardson A. A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture. Ann Oncol. 2013 Jun;24(6):1645-52. doi: 10.1093/annonc/mdt034. Epub 2013 Feb 21.
- Derived from this study: PubMed 23109700Molassiotis A, Bardy J, Finnegan-John J, Mackereth P, Ryder DW, Filshie J, Ream E, Richardson A. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol. 2012 Dec 20;30(36):4470-6. doi: 10.1200/JCO.2012.41.6222. Epub 2012 Oct 29.
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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.
Alex Molassiotis, MD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acupuncture therapy and standard follow-up care in people with Anxiety Disorder and Breast Cancer, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. 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 United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
General fatigue as measured by the Multidimensional Fatigue Inventory. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957112, which also lists 2 linked publications.
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 26 Aug 2013.