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

This study has been completed.
Sponsor:
Collaborators:
Sidney Kimmel Comprehensive Cancer Center
Information provided by (Responsible Party):
Ting Bao, University of Maryland
ClinicalTrials.gov Identifier:
NCT00641303
First received: March 21, 2008
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Breast Cancer
Depression
Fatigue
Hot Flashes
Pain
Sleep Disorders
Procedure: acupuncture therapy
Procedure: sham intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Health Assessment Questionnaire Disability Index (HAQ-DI) score [ Time Frame: Baseline, Weeks 4, 8 and 12 (or Week 24) ] [ Designated as safety issue: No ]
  • Pain scores on visual analog scale (VAS) [ Time Frame: Baseline, Weeks 4, 8 and 12 (or Week 24) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in amount and/or frequency of oral analgesic use [ Time Frame: Baseline, Weeks 1-8, Week 12 (or Week 24) ] [ Designated as safety issue: No ]
  • Number of patients who discontinue or change AI therapy [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change in plasma estrogen concentrations, beta endorphin concentration, and cytokine profile from week 0 to week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: May 2008
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 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 or 24-week follow-up visit.
Procedure: sham intervention
Given weekly for 8 sessions
Other Name: sham acupuncture
Experimental: 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.
Procedure: acupuncture therapy
Given weekly for 8 sessions
Other Name: acupuncture

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641303

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Ting Bao, MD University of Maryland Marlene & Stewart Greenebaum Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ting Bao, Assistant Profressor, University of Maryland
ClinicalTrials.gov Identifier: NCT00641303     History of Changes
Other Study ID Numbers: HP-00043225, P30CA006973, JHOC-J07110, SKCCC J07110, JHOC-NA_00013024, GCC 0930
Study First Received: March 21, 2008
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
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

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Depression
Depressive Disorder
Fatigue
Sleep Disorders
Parasomnias
Hot Flashes
Mental Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014