Improving Fatigue: A Pilot Study of Acupuncture and Patient Education for Breast Cancer Survivors

Jonsson Comprehensive Cancer Center

Status: Completed

Conditions: Fatigue

Treatments: Procedure: Acupuncture and patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT00646633

06-08-010

Details and patient eligibility

About

Based on the investigators clinical experience in patients with chronic disease (Hui, Hui, and Johnston, 2006; Hays et al 2005), a review of the literature (Johnston, Xiao and Hui 2007), and inspired by Vickers and colleagues (PMID: 15117996), the investigators carry out a pilot study that investigates if acupuncture combined with patient education will relieve fatigue in patients who have completed primary treatment for breast cancer.

Full description

Patients will be randomly assigned to one of the two groups. Our hypothesis is that patients in the acupuncture/education group will experience greater relief of fatigue than those in the standard care group.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is between 18 and 65 years of age
2. Patient has a rounded Brief Fatigue Inventory score of 4 or greater
3. Patient is in a stable clinical condition

Exclusion criteria

1. Severe anemia (hemoglobin level less than 9 g/dL, hematocrit level less than 30, decline in hemoglobin of 2 g/dL in the previous month, or active treatment for anemia)
2. Karnofsky Performance Status below 70
3. Acupuncture treatment in the previous 6 months
4. Fatigue before cancer diagnosis
5. Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview
6. Patient has the potential for serious bleeding due to inherited diseases such as hemophilia
7. Patient is taking medications that are either fatigue-inducing or have sedating properties
8. Patient is unavailable by telephone

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Acupuncture & educ

Active Comparator group

Description:

Patients will receive a total of 8 acupuncture treatments. In each of the first four sessions, they will also receive patient education.

Treatment:

Procedure: Acupuncture and patient education

2. Standard care

No Intervention group

Description:

Patients in the control arm will continue to receive standard care from their physician.