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Completed

NCT Number: NCT01727362

Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy

The aim of this trial is to investigate the effectiveness of acupuncture on quality of life in patients with breast cancer receiving chemotherapy compared to routine care.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, 20357, Germany

About this study

At the Mammazentrum Hamburg, Germany, patients with breast cancer receiving chemotherapy have the opportunity to get acupuncture in addition to conventional therapy to maintain quality of life and to reduce the side effects of the chemotherapy such as gastrointestinal disorders. In this randomized trial we aim to investigate the effectiveness of additional acupuncture compared to routine care in patients with breast cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed breast cancer (invasive, intraductal, hormone-sensitive and not hormone-sensitive, only locoregional metastases)
  • current chemotherapy at Mammazentrum Hamburg with regimen FEC/DOC or EC/DOC
  • willingness to receive acupuncture within the next 6 month if randomized in acupuncture group
  • willingness to refrain from acupuncture within the next 6 month if randomized in control group
  • informed consent

Exclusion criteria

  • distant metastases
  • blood coagulation disorder and/or current use of anticoagulants
  • serious acute or chronic mental or physical disorders
  • clinically relevant cardiac arrhythmia symptoms
  • insufficient German language ability

Treatment and study plan

Usual care + acupuncture

Other

Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care

Usual Care

Other

Patients of this group receive usual care only

Primary outcomes

  1. Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    Time frame: 6 month

Secondary outcomes

  1. Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    Time frame: 3 month

Other outcomes

  1. Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being

    Time frame: 3 month

  2. Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being

    Time frame: 6 month

  3. Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    Time frame: 3 month

  4. Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)

    Time frame: 6 month

  5. Pain, quality of sleep, and nausea (single items of the FACT-B)

    Time frame: 3 month

  6. Pain, quality of sleep, and nausea (single items of the FACT-B)

    Time frame: 6 month

  7. Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: 3 month

  8. Functional Assessment of Chronic Illness Therapy-Fatigue

    Time frame: 6 month

  9. FACT/GOG-NTX, polyneuropathy symptoms

    Time frame: 3 month

  10. FACT/GOG-NTX, polyneuropathy symptoms

    Time frame: 6 month

  11. Quality of Life (SF-12 Health Survey)

    Time frame: 3 month

  12. Quality of Life (SF-12 Health Survey)

    Time frame: 6 month

  13. Survival without relapse

    Time frame: 6 month

  14. Survival

    Time frame: 6 month

  15. Adverse effects and Interactions

    Time frame: 3 month

  16. Adverse effects and Interactions

    Time frame: 6 month

  17. Satisfaction and patient-reported effectiveness

    Time frame: 3 month

    This will only be assessed in the acupuncture arm

  18. Satisfaction and patient-reported effectiveness

    Time frame: 6 month

    This will only be assessed in the acupuncture arm

  19. Goal Attainment Scale

    Time frame: 3 month

    This will only be assessed in the acupuncture arm

  20. Goal Attainment Scale

    Time frame: 6 month

    This will only be assessed in the acupuncture arm

  21. Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)

    Time frame: 3 month

  22. Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany
  • Prof. Otto Beisheim Foundation

Registry information

Official study title

Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2012
Registry last updated
Jul 24, 2017

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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