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

NCT00641303 | Completed DMC

• 6 other identifiers: HP-00043225P30CA006973JHOC-J07110SKCCC J07110JHOC-NA_00013024GCC 0930
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief 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 anastrozole for stage 0, stage I, stage II, or stage III breast cancer.

Conditions

Anxiety Disorder; Breast Cancer; Depression; Fatigue; Hot Flashes; Pain; Sleep Disorders

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

Outcome Measures

Primary Outcomes (2)

• Health Assessment Questionnaire Disability Index (HAQ-DI) score

  Baseline, Weeks 4, 8 and 12 (or Week 24)

• Pain scores on visual analog scale (VAS)

  Baseline, Weeks 4, 8 and 12 (or Week 24)

Secondary Outcomes (4)

• Change in amount and/or frequency of oral analgesic use

  Baseline, Weeks 1-8, Week 12 (or Week 24)

• Number of patients who discontinue or change AI therapy

  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

  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

  Baseline, Week 8

Study Arms (2)

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.

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.

Procedure: acupuncture therapy

Interventions

acupuncture therapy PROCEDURE

Given weekly for 8 sessions

Also known as: acupuncture

Arm II (treatment)

sham intervention PROCEDURE

Given weekly for 8 sessions

Also known as: sham acupuncture

Arm I (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Cancer Institute (NCI): collaborator
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: collaborator

Study Sites (2)

University of Maryland Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Depression; Fatigue; Hot Flashes; Pain; Sleep Wake Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ting Bao, MD

  University of Maryland Marlene & Stewart Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 24, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 8, 2023

Record last verified: 2012-01

Locations

US (2)