Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy
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|ClinicalTrials.gov Identifier: NCT02831114|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Neuropathy||Other: Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluating the Effects of Acupuncture in the Treatment of Taxane Induces Peripheral Neuropathy (TIPN)|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||January 2018|
The nine participants in the intervention arm will receive 18 acupuncture treatments over the course of 12 weeks (2 treatments per week for 6 weeks and 1 treatment per week for 6 weeks). They will undergo assessments at baseline, 6 weeks, and 12 weeks through the use of questionnaires and blood tests. The participants will also be allowed to continue their conventional therapy for TIPN.
Acupuncture uses tiny needles to promote blood flow, nervous system signaling, and brings the body back into homeostasis which the state of optimum functioning. Treatment for taxane induced peripheral neuropathy will consist of traditional acupuncture and will use points located in the foot (SP 3, ST 41, LR 3, K 3, GB 41), knee (SP 9, ST 36, K 10, GB 34), and arm (LI 11). Participants will continue to take their conventional therapy. Each acupuncture treatment will take place at Oriental Medicine Associates with trained acupuncturist, William Hendry. Each session should last about 30 minutes.
No Intervention: Control
The nine participants in this arm will undergo the same assessments as the intervention arm at baseline, 6 weeks, and 12 weeks. They will not receive any acupuncture treatments during this time, but will be allowed to continue their conventional therapy. The control arm will be offered the same 18 acupuncture treatments after a wait of at least 12 weeks.
- Change in taxane induced peripheral neuropathy symptoms measured by the Patients' Global Impression of Change (PGIC) scale. [ Time Frame: 12 Weeks ]All 18 participants will complete the PGIC scale at 6 weeks and 12 weeks. This scale will ask questions about the participants' change in activity limitations, symptoms, emotions, and overall quality of life related to their peripheral neuropathy since the beginning of treatment.
- Evaluate the mechanism of acupuncture as a treatment of TIPN through quantification of inflammatory biomarkers and circulation levels of mitochondrial DNA (mtDNA) [ Time Frame: 12 Weeks ]Approximately 8ml of blood will be collected from each participant at baseline, 6 weeks, and 12 weeks. The samples will be collected in purple top BD vacutainers.
- Change in quality of life using the FACT/GOG-NTX questionnaire [ Time Frame: 12 Weeks ]Participants will complete the FACT/GOG-NTX questionnaire at baseline, 6 weeks, and 12 weeks. The questionnaire includes questions about the participants' physical, social/family, emotional, and functional well-being.
- Evaluate if neuropathic mechanisms are contributing to pain measured by the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale [ Time Frame: 12 Weeks ]Participants will complete the LANSS Pain Scale at baseline, 6 weeks, and 12 weeks. This pain scale involves a pain questionnaire and sensory testing to determine to determine if neuropathic mechanisms are still contributing to the participant's pain.
- Change in taxane induced peripheral neuropathy related pain measured by the Brief Pain Inventory (BPI). [ Time Frame: 12 Weeks ]Participants will complete the BPI at baseline, 6 week, and 12 week. The BPI will ask questions to detail how the pain interferes with the participants' general activity, mood, walking ability, relationships, sleep, and enjoyment of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831114
|United States, South Carolina|
|Greenville Health System Cancer Institute Center for Integrative Oncology and Survivorship|
|Greenville, South Carolina, United States, 29605|
|Principal Investigator:||Mark A O'Rourke, MD||Prisma Health-Upstate|
|Principal Investigator:||Renee J LeClair, PhD||University of South Carolina School of Medicine, Greenville|