Anxiety DisorderNCT00641303
Acupuncture in Reducing Muscle and Bone Symptoms in Women Receiving Letrozole, Exemestane, or Anastrozole for Stage 0, Stage I, Stage II, or Stage III Breast Cancer
A study testing acupuncture therapy in people with Anxiety Disorder and Breast Cancer, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
RATIONALE: Acupuncture may help relieve muscle and bone pain caused by aromatase inhibitor therapy, such as letrozole, exemestane, and anastrozole. PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works in reducing muscle and bone symptoms in women receiving letrozole, exemestane, or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety Disorder, Breast Cancer, Depression
- What is being tested?
- acupuncture therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Nov 2011
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive carcinoma of the breast
- Stage 0-III disease
- Estrogen receptor- and/or progesterone receptor-positive by immunohistochemical staining
- Must be receiving a standard dose of aromatase inhibitor (AI) therapy (i.e., letrozole 2.5 mg once daily, exemestane 25 mg once daily, or anastrozole 1 mg once daily)
- AI therapy has been ongoing for ≥ 1 month and treatment is expected to continue
- AI-associated musculoskeletal symptoms, defined as ≥ 1 of the following:
- Physician-confirmed AI-associated musculoskeletal symptoms
- Patients concurrently enrolled on the clinical trial, "A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response with Aromatase Polymorphism," and who have met the referral criteria for a rheumatological evaluation
- No known metastatic (stage IV) breast cancer
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Female
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- No prior acupuncture within past 12 months.
- No other concurrent systemic therapy (i.e., chemotherapy, biologic therapy, or radiotherapy) unless approval is given by the Protocol Chair
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of Acupuncture in Reducing Musculoskeletal Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors
RATIONALE: Acupuncture may help relieve muscle and bone pain caused by aromatase inhibitor therapy, such as letrozole, exemestane, and anastrozole.
PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works in reducing muscle and bone symptoms in women receiving letrozole, exemestane, or anastrozole for stage 0, stage I, stage II, or stage III breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine if acupuncture can reduce aromatase inhibitor (AI)-associated musculoskeletal symptom severity, in terms of function and pain, in woman with stage 0-III breast cancer.
Secondary
- To assess if acupuncture decreases oral analgesic use in these patients.
- To assess if acupuncture decreases the proportion of patients who change or discontinue AI therapy.
- To assess if acupuncture improves menopausal symptoms, mood (i.e., depression or anxiety), sleep quality and sleep disturbance, and overall quality of life of these patients.
- To assess if acupuncture changes plasma concentrations of estrogens (i.e., E1, E2, and E1S), cytokine profile, and beta endorphin.
OUTLINE: This is a multicenter study. Patients are stratified according to participation in the aromatase inhibitor trial, "A Multicenter Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism" (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients receive 8 weekly sessions of sham acupuncture treatment comprising 20 minutes of a non-penetrating device consisting of a retractable needle and an adhesive tube on the skin using the Park Sham Device (PSD) in 14 non-acupuncture points. Patients may receive 4 free acupuncture sessions (not sham) after the 12-week (previously 24-week) follow-up visit.
- Arm II (treatment): Patients receive 8 weekly sessions of acupuncture treatment comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4, CV 6, CV12 and bilateral LI 4, MH 6, GB 34, ST 36, KI 3, BL 65.
Quality of life is assessed periodically to measure changes in symptoms that may be related to hot flashes and estrogen deprivation (i.e., menopausal symptoms, mood [depression and anxiety], sleep quality, and overall quality of life using the menopausal symptoms checklist); the Hot Flash Related Daily Interference Scale (HFRDI) and the Hot Flash Daily Diary; the Pittsburgh Sleep Quality Index (PSQI); the Center for Epidemiologic Studies Depression Scale (CESD); the Hospital Anxiety and Depression Scale (HADS-A); and the EuroQOL.
Patients complete questionnaires including the Health Assessment Questionnaire (HAQ) and visual analog scales (VAS) to assess both pain and global health status at baseline, after 4 and 8 weeks of acupuncture or sham acupuncture, and at follow-up at 12 weeks (previously 24 weeks). The average amount of daily oral analgesic usage is assessed at weeks 0, 4, 8, and 12(previously 24).
Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for plasma concentrations of estrogen (i.e., estrone E1, estradiol E2, and estrone sulfate E1S) via HPLC-MS/MS, level of 35 serum cytokines via addressable laser bead immunoassay (ALBIA) or classical sandwich ELISA, cytokines and their soluble receptors via classical sandwich ELISA techniques, and Beta-endorphin via competitive ELISA.
All patients are followed for 12 weeks(previously 24 weeks). Patients in arm I may be followed for an additional 4 weeks if they choose to receive the free acupuncture sessions.
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Fatigue, Hot Flashes, Pain
- Being tested
- acupuncture therapy, sham intervention
- Keywords
- pain, fatigue, hot flashes, sleep disorders, depression, anxiety disorder, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Depression, Fatigue, Hot Flashes, Pain, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture therapyProcedure or surgery
Also called acupuncture
Given weekly for 8 sessions
sham interventionProcedure or surgery
Also called sham acupuncture
Given weekly for 8 sessions
| Study group | Role | What they receive |
|---|---|---|
| Arm I (control) | Sham comparator | Patients receive 8 weekly sessions of sham acupuncture treatment comprising 20 minutes of a non-penetrating device consisting of a retractable needle and an adhesive tube on the skin using the Park Sham Device (PSD) in 14 non-acupuncture points. Patients may receive 4 free acupuncture sessions (not sham) after the 12 or 24-week follow-up visit. Receives: Procedure: sham intervention |
| Arm II (treatment) | Experimental | Patients receive 8 weekly sessions of acupuncture treatment comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4, CV 6, CV12 and bilateral LI 4, MH 6, GB 34, ST 36, KI 3, BL 65. Receives: Procedure: acupuncture therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Assessment Questionnaire Disability Index (HAQ-DI) score
Measured: Baseline, Weeks 4, 8 and 12 (or Week 24)
Pain scores on visual analog scale (VAS)
Measured: Baseline, Weeks 4, 8 and 12 (or Week 24)
Secondary outcomes (4)
Change in amount and/or frequency of oral analgesic use
Measured: Baseline, Weeks 1-8, Week 12 (or Week 24)
Number of patients who discontinue or change AI therapy
Measured: All timepoints
Change in menopausal symptoms (NSABP-revised), hot flash frequency (HFRDIS), sleep quality (PSQI), depression score (CESD), and overall quality of life (EuroQOL) in patients at weeks 4, 8, and 24 vs week 0 of acupuncture treatment
Measured: Baseline, Weeks 4, 8 and 12 (or Week 24)
Change in plasma estrogen concentrations, beta endorphin concentration, and cytokine profile from week 0 to week 8
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Responsible party
- Sponsor
- Investigators
- Ting Bao, MD, Principal investigator, University of Maryland Marlene & Stewart Greenebaum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641303
- Sponsor's protocol ID
- HP-00043225
- Other IDs
- P30CA006973, JHOC-J07110, SKCCC J07110, JHOC-NA_00013024, GCC 0930
- Status last verified
- Jan 2012
- First submitted
- 21 Mar 2008
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Controlled Double Blind Trial Assessing the Effect of Acupuncture in Reducing Musculoskeletal Symptoms in Breast Cancer Patients Taking Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT00641303
- Acronym / sponsor ID
- HP-00043225
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Fatigue, Hot Flashes, Pain
- Keywords
- pain, fatigue, hot flashes, sleep disorders, depression, anxiety disorder, stage I breast cancer, stage II breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study start
- May 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Mar 2008 (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 muscle and bone pain caused by aromatase inhibitor therapy, such as letrozole, exemestane, and anastrozole.
PURPOSE: This randomized phase II trial is studying acupuncture to see how well it works in reducing muscle and bone symptoms in women receiving letrozole, exemestane, or anastrozole for stage 0, stage I, stage II, or stage III breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine if acupuncture can reduce aromatase inhibitor (AI)-associated musculoskeletal symptom severity, in terms of function and pain, in woman with stage 0-III breast cancer.
Secondary
- To assess if acupuncture decreases oral analgesic use in these patients.
- To assess if acupuncture decreases the proportion of patients who change or discontinue AI therapy.
- To assess if acupuncture improves menopausal symptoms, mood (i.e., depression or anxiety), sleep quality and sleep disturbance, and overall quality of life of these patients.
- To assess if acupuncture changes plasma concentrations of estrogens (i.e., E1, E2, and E1S), cytokine profile, and beta endorphin.
OUTLINE: This is a multicenter study. Patients are stratified according to participation in the aromatase inhibitor trial, "A Multicenter Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism" (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients receive 8 weekly sessions of sham acupuncture treatment comprising 20 minutes of a non-penetrating device consisting of a retractable needle and an adhesive tube on the skin using the Park Sham Device (PSD) in 14 non-acupuncture points. Patients may receive 4 free acupuncture sessions (not sham) after the 12-week (previously 24-week) follow-up visit.
- Arm II (treatment): Patients receive 8 weekly sessions of acupuncture treatment comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4, CV 6, CV12 and bilateral LI 4, MH 6, GB 34, ST 36, KI 3, BL 65.
Quality of life is assessed periodically to measure changes in symptoms that may be related to hot flashes and estrogen deprivation (i.e., menopausal symptoms, mood [depression and anxiety], sleep quality, and overall quality of life using the menopausal symptoms checklist); the Hot Flash Related Daily Interference Scale (HFRDI) and the Hot Flash Daily Diary; the Pittsburgh Sleep Quality Index (PSQI); the Center for Epidemiologic Studies Depression Scale (CESD); the Hospital Anxiety and Depression Scale (HADS-A); and the EuroQOL.
Patients complete questionnaires including the Health Assessment Questionnaire (HAQ) and visual analog scales (VAS) to assess both pain and global health status at baseline, after 4 and 8 weeks of acupuncture or sham acupuncture, and at follow-up at 12 weeks (previously 24 weeks). The average amount of daily oral analgesic usage is assessed at weeks 0, 4, 8, and 12(previously 24).
Patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for plasma concentrations of estrogen (i.e., estrone E1, estradiol E2, and estrone sulfate E1S) via HPLC-MS/MS, level of 35 serum cytokines via addressable laser bead immunoassay (ALBIA) or classical sandwich ELISA, cytokines and their soluble receptors via classical sandwich ELISA techniques, and Beta-endorphin via competitive ELISA.
All patients are followed for 12 weeks(previously 24 weeks). Patients in arm I may be followed for an additional 4 weeks if they choose to receive the free acupuncture sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (control) | Sham comparator | Procedure: sham interventionPatients receive 8 weekly sessions of sham acupuncture treatment comprising 20 minutes of a non-penetrating device consisting of a retractable needle and an adhesive tube on the skin using the Park Sham Device (PSD) in 14 non-acupuncture points. Patients may receive 4 free acupuncture sessions (not sham) after the 12 or 24-week follow-up visit. |
| Arm II (treatment) | Experimental | Procedure: acupuncture therapyPatients receive 8 weekly sessions of acupuncture treatment comprising 20 minutes of needle insertion in 15 acupuncture points including CV 4, CV 6, CV12 and bilateral LI 4, MH 6, GB 34, ST 36, KI 3, BL 65. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 therapyAlso: acupunctureGiven weekly for 8 sessions | Procedure or surgery | Arm II (treatment) |
| sham interventionAlso: sham acupunctureGiven weekly for 8 sessions | Procedure or surgery | Arm I (control) |
Primary outcome
Health Assessment Questionnaire Disability Index (HAQ-DI) score
Time frame: Baseline, Weeks 4, 8 and 12 (or Week 24)
Pain scores on visual analog scale (VAS)
Time frame: Baseline, Weeks 4, 8 and 12 (or Week 24)
4 secondary outcomes
Change in amount and/or frequency of oral analgesic use
Time frame: Baseline, Weeks 1-8, Week 12 (or Week 24)
Number of patients who discontinue or change AI therapy
Time frame: All timepoints
Change in menopausal symptoms (NSABP-revised), hot flash frequency (HFRDIS), sleep quality (PSQI), depression score (CESD), and overall quality of life (EuroQOL) in patients at weeks 4, 8, and 24 vs week 0 of acupuncture treatment
Time frame: Baseline, Weeks 4, 8 and 12 (or Week 24)
Change in plasma estrogen concentrations, beta endorphin concentration, and cytokine profile from week 0 to week 8
Time frame: Baseline, Week 8
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 8 May 2023.
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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.
Ting Bao, MD principal investigator
University of Maryland Marlene & Stewart Greenebaum Cancer Center
2 sites 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 Anxiety Disorder and Breast Cancer, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 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?
Health Assessment Questionnaire Disability Index (HAQ-DI) score (time frame: Baseline, Weeks 4, 8 and 12 (or Week 24)). The study lists 2 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 8 May 2023.