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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727362
• Other study ID #: ACU in breast cancer
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: July 21, 2017
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Usual care + acupuncture
Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care
• Usual care
Patients of this group receive usual care only

Locations

Country	Name	City	State
Germany	Mammazentrum Hamburg am Krankenhaus Jerusalem	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Dorit und Alexander Otto Stiftung, Hamburg, Germany, Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being		3 month
Other	Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being		6 month
Other	Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)		3 month
Other	Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)		6 month
Other	Pain, quality of sleep, and nausea (single items of the FACT-B)		3 month
Other	Pain, quality of sleep, and nausea (single items of the FACT-B)		6 month
Other	Functional Assessment of Chronic Illness Therapy-Fatigue		3 month
Other	Functional Assessment of Chronic Illness Therapy-Fatigue		6 month
Other	FACT/GOG-NTX, polyneuropathy symptoms		3 month
Other	FACT/GOG-NTX, polyneuropathy symptoms		6 month
Other	Quality of Life (SF-12 Health Survey)		3 month
Other	Quality of Life (SF-12 Health Survey)		6 month
Other	Survival without relapse		6 month
Other	Survival		6 month
Other	Adverse effects and Interactions		3 month
Other	Adverse effects and Interactions		6 month
Other	Satisfaction and patient-reported effectiveness	This will only be assessed in the acupuncture arm	3 month
Other	Satisfaction and patient-reported effectiveness	This will only be assessed in the acupuncture arm	6 month
Other	Goal Attainment Scale	This will only be assessed in the acupuncture arm	3 month
Other	Goal Attainment Scale	This will only be assessed in the acupuncture arm	6 month
Other	Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)		3 month
Other	Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)		6 month
Primary	Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)		6 month
Secondary	Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)		3 month