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Completed

NCT Number: NCT00646633

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

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.

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Key information

Conditions

Fatigue Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Center for East-West Medicine

Santa Monica, California, 90404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • Karnofsky Performance Status below 70
  • Acupuncture treatment in the previous 6 months
  • Fatigue before cancer diagnosis
  • Patient is mentally incapacitated or unfit to provide informed consent or participate in an interview
  • Patient has the potential for serious bleeding due to inherited diseases such as hemophilia
  • Patient is taking medications that are either fatigue-inducing or have sedating properties
  • Patient is unavailable by telephone

Treatment and study plan

Acupuncture and patient education

Procedure

Acupuncture involves the insertion of extremely thin needles, much thinner than those used for drawing blood, into very specific acupuncture points. Patients will receive a total of 8 acupuncture treatments, each lasting 50 minutes. Patient education will be delivered to individuals over the course of approximately 50 minutes for each of the four sessions; topics will include acupressure, nutrition, exercise, stress management, and lifestyle advice.

Other names: Traditional Chinese Medicine, Integrative East-West Medicine

Primary outcomes

  1. Fatigue as measured by the Brief Fatigue Inventory

    Time frame: prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.

Secondary outcomes

  1. Health-Related Quality of Life (HRQoL) as measured by the SF36

    Time frame: prior to beginning of treatment and after end of treatment. Up to an average of 44 weeks.

  2. Pain as measured by an analog scale

    Time frame: prior to beginning of treatment and after conclusion of treatment. Up to an average of 44 weeks.

  3. Cognitive complaints as measured by the FACT-COG

    Time frame: prior to the beginning of treatment and after end of treatment. Up to an average of 44 weeks.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Susan G. Komen Breast Cancer Foundation

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 28, 2008
Registry last updated
Jul 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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