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Acupuncture and Aromatase Inhibitor Related Arthralgia


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

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Trial Information

Acupuncture and Aromatase Inhibitor Related Arthralgia


PRIMARY OBJECTIVES:

I. To determine the overall effect of acupuncture for reducing arthralgia among breast
cancer survivors (BCS) receiving AIs.

II. To explore the specific effect of acupuncture needling for reducing arthralgia among BCS
receiving AIs.

III. To elucidate the relationship between response expectancy measured by the Acupuncture
Expectancy Scale (AES) and clinical response to acupuncture defined as percent reduction of
BPI pain severity score at the end of intervention.

SECONDARY OBJECTIVES:

I. To explore the effects of acupuncture on other common symptoms including fatigue,
insomnia, and psychological distress among BCS who experience joint pain.

II. To determine the correlation among pain and fatigue, insomnia, and psychological
distress using previously validated instruments.

III. To explore the effects of acupuncture on quality of life among BCS who experience joint
pain.

IV. To explore the effect of acupuncture on objective measure of sleep and activity.

V. To identify potential genetic determinants to response to acupuncture.

OUTLINE:

Patients are randomized to 1 of 3 treatment arms.

ARM I (Acupuncture): Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks
(twice weekly for 2 weeks and 6 weekly treatments).

ARM II (Placebo): Patients undergo 10, 20-minute sessions of sham acupuncture treatments
over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at
non-acupuncture points.

ARM III (Control): Wait-list control patients are contacted by phone at the same frequency
as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.

After completion of study treatment, patients are followed at 4 weeks.

Inclusion Criteria


Inclusion

- History of stage I, II, or III breast cancer

- Visit with oncologist within the previous 3-month period and free of disease by
clinical examination and history

- Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) as
per chart abstraction

- Postmenopausal, as defined by cessation of menses for a least 1 year or FSH > 40
mlU/mL

- Can understand written English

- Having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical
rating scale in the preceding week

- Having had at least 15 days with pain in the preceding 30 days

- Having had joint pain for at least 3 months

- Joint pain attributed to the use of aromatase inhibitors

- Willingness to adhere to all study-related procedures including randomization to one
of the three possible choices: real acupuncture, placebo acupuncture, and wait-list
control

Exclusion

- Women with metastatic (stage IV) breast cancer

- Women having finished chemotherapy or radiation therapy less than 4 weeks prior to
enrollment

- History of bleeding disorder

- Joint pain attributed to inflammatory arthritis (such as rheumatoid arthritis, gout,
pseudo gout)

- Having severe pain or non-inflammatory arthralgia prior to AI initiation per
patient's history

- Surgery or joint injection involving the treatment joint within the last 3 months

- Have previously participated in the acupuncture trial for hot flashes in the last
year

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain as measured by Brief Pain Inventory (BPI) pain severity score

Safety Issue:

No

Principal Investigator

Jun Mao

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

UPCC 07109

NCT ID:

NCT01013337

Start Date:

May 2009

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • Recurrent Breast Cancer
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Breast Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283