Clinical trial NCT01727362: Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy
Official title: Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Acupuncture
Quality of Life
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany
name: Dorit und Alexander Otto Stiftung, Hamburg, Germany
First posted: 2012-11-16
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: 6 month
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: 3 month
Other outcomes:
measure: Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being
timeFrame: 3 month
measure: Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being
timeFrame: 6 month
measure: Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: 3 month
measure: Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: 6 month
measure: Pain, quality of sleep, and nausea (single items of the FACT-B)
timeFrame: 3 month
measure: Pain, quality of sleep, and nausea (single items of the FACT-B)
timeFrame: 6 month
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: 3 month
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: 6 month
measure: FACT/GOG-NTX, polyneuropathy symptoms
timeFrame: 3 month
measure: FACT/GOG-NTX, polyneuropathy symptoms
timeFrame: 6 month
measure: Quality of Life (SF-12 Health Survey)
timeFrame: 3 month
measure: Quality of Life (SF-12 Health Survey)
timeFrame: 6 month
measure: Survival without relapse
timeFrame: 6 month
measure: Survival
timeFrame: 6 month
measure: Adverse effects and Interactions
timeFrame: 3 month
measure: Adverse effects and Interactions
timeFrame: 6 month
measure: Satisfaction and patient-reported effectiveness
timeFrame: 3 month
measure: Satisfaction and patient-reported effectiveness
timeFrame: 6 month
measure: Goal Attainment Scale
timeFrame: 3 month
measure: Goal Attainment Scale
timeFrame: 6 month
measure: Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)
timeFrame: 3 month
measure: Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)
timeFrame: 6 month
Locations:
city: Hamburg
country: Germany
facility: Mammazentrum Hamburg am Krankenhaus Jerusalem
Study officials:
affiliation: Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany
name: Martin Carstensen, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockigt DMB, Kirschbaum B, Carstensen DMM, Witt DMCM, Brinkhaus DMB. Prophylactic Acupuncture Treatment During Chemotherapy in Patients With Breast Cancer: Results of a Qualitative Study Nested in a Randomized Pragmatic Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058207. doi: 10.1177/15347354211058207.
citation: Brinkhaus B, Kirschbaum B, Stockigt B, Binting S, Roll S, Carstensen M, Witt CM. Prophylactic acupuncture treatment during chemotherapy with breast cancer: a randomized pragmatic trial with a retrospective nested qualitative study. Breast Cancer Res Treat. 2019 Dec;178(3):617-628. doi: 10.1007/s10549-019-05431-5. Epub 2019 Sep 13.