A Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients
Taxane-induced Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Early-Stage Breast Carcinoma
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Procedure: Immediate Acupuncture Group
Procedure: Delayed Acupuncture Group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Randomized Pilot Study of Acupuncture for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients|
- Response Rate from Baseline in PNQ Score [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]The PNQ includes two questionnaire items: one asking about sensory neurotoxicity and the other asking about motor neurotoxicity. The questionnaire items correspond to the neurotoxicity questions included in the NCI-CTCAE. PNQ grades range from grade A (no neuropathy) to grade E (very severe neuropathy). Answer options will be coded 0=A to 4=E, with a higher score indicating more severe CIPN
- Changes in FACT/NTX subscale baseline to 8 weeks [ Time Frame: Baseline, 8 Weeks ] [ Designated as safety issue: No ]
- Changes in EORTC-QLQ-CIPN20 subscale Baseline, 8 Weeks [ Time Frame: Baseline, 8 Weeks ] [ Designated as safety issue: No ]Comprised of three subscales assessing sensory, motor, and autonomic symptoms. Subscale scores will be calculated and linearly transformed to a 0 to 100 scale, with higher scores suggesting more severe symptoms. Changes from baseline (8-week - baseline) between the intervention arms for each subscale will be of interest.
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Immediate Acupuncture Group
Immediate acupuncture arm will receive acupuncture 3 times per week during week 1 and week 2, then 2 times per week from week 2 to week 8 for a total of 18 sessions. The crossover will take place after 8th week.
The immediate acupuncture arm will enter a follow-up phase without acupuncture for 8 weeks from week 9 to week 16, while the standard usual care will be provided.
|Procedure: Immediate Acupuncture Group|
Active Comparator: Delayed Acupuncture Group
The patients on the usual care/delayed acupuncture arm will continue their standard usual care with their physicians and care team. The crossover will take place after 8th week. After crossover, the patients initially on the usual care/delayed acupuncture arm will receive the identical acupuncture protocol but a less frequent schedule from week 9 to week 16: 2 times per week at week 9, then 1 time per week from week 10 to week 16 for a total of 9 sessions
|Procedure: Delayed Acupuncture Group|
Chemotherapy drugs used to treat cancer can cause temporary or permanent damage to the nerves in the hands and feet, a condition called "chemotherapy-induced peripheral neuropathy". The most common symptoms of chemotherapy-induced peripheral neuropathy are pain, tingling, burning or numbness sensation, which can lead to balance problems or trouble using fingers or pick up/holding things. These symptoms often last months to years after the completion of chemotherapy. Medications and nutritional supplements can ease the symptoms of chemotherapy-induced peripheral neuropathy, but many patients continue to experience symptoms despite these treatments.
Acupuncture is an intervention in which hair-thin, stainless steel needles are shallowly inserted into specific points on the skin, with the goal of influencing the body's natural healing system. Acupuncture has been studied in clinical trials in cancer patients and has been shown to be effective for various conditions including chemotherapy-induced nausea and vomiting. A few preliminary studies have suggested that acupuncture may help to reduce symptoms of peripheral neuropathy, but more information is needed about the benefits of acupuncture in breast cancer patients This study is being done to evaluate the potential benefits of using acupuncture to reduce symptoms of tingling, burning, numbness and pain in the hands and feet of women with peripheral neuropathy after completion of chemotherapy for breast cancer.
This research study will help to determine the benefits of acupuncture for the treatment of chemotherapy-induced peripheral neuropathy. The study will also look at two different acupuncture schedules to determine whether patients derive benefits from lower and higher dose acupuncture treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02129686
|Contact: Kelly D Stecker||617-632-6731||kellyD_stecker@dfci.harvard.edu|
|Contact: Laura Shockrofirstname.lastname@example.org|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Weidong Lu, M.B.,MPH, PhD (617) 632-3322 Weidong_lu@dfci.harvard.edu|
|Principal Investigator: Weidong Lu, M.B., MPH, PhD|
|Principal Investigator:||Weidong Lu, M.B., MPH, Ph.D||Dana-Farber Cancer Institute|