Status:
COMPLETED
Standard Care Alone or With Acupuncture for CIPN in Breast Cancer and Multiple Myeloma
Lead Sponsor:
The Christie NHS Foundation Trust
Conditions:
Breast Cancer
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the addition of acupuncture to standard treatment reduces the level of chemotherapy induced peripheral neuropathy experienced by patients with breast ...
Detailed Description
Chemotherapy Induced Peripheral Neuropathy (CIPN) is a significant clinical challenge for patients receiving specific chemotherapy regimen (e.g. taxanes and Bortezomib) and critically, if severe, CIPN...
Eligibility Criteria
Inclusion
- Patients with breast cancer, multiple myeloma, gastrointestinal cancer or gynaecological cancer who are receiving or who have received neurotoxic chemotherapy treatment for their condition
- The capacity to understand the patient information sheet and the ability to give written informed consent
- Willingness and ability to comply with scheduled visits and study procedures, including the self-report QoL questionnaires and patient diaries
- Age ≥ 18 years; no upper age limit
- CIPN of ≥ Grade II (CTCAE v4.03)
- Platelet count of ≥ 30 x 10\*9/L
- Neutrophil count of ≥ 0.5 x 10\*9/L
- MYMOP2 score of their most troubling CIPN symptom ≥ 3
Exclusion
- Patients who have previously received acupuncture for neuropathy
- Patients who have received acupuncture for any indication, other than neuropathy, within the previous 6 months
- Women who are pregnant or breast feeding
- Co-morbidity with a bleeding disorder
- Patients with an aversion to needles
Key Trial Info
Start Date :
April 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02275403
Start Date
April 13 2015
End Date
December 17 2018
Last Update
January 31 2019
Active Locations (2)
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1
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
2
The Royal Oldham Hospital
Oldham, United Kingdom, OL1 2JH