Phase 2 Study of Acupuncture-Like Transcutaneous Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy

Abstract

A prospective phase 2 study was conducted to evaluate the clinical utility of acupuncture-like transcutaneous nerve stimulation (ALTENS) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). Eligible cancer patients had a < 2 ECOG performance score, received neurotoxic chemotherapy, and developed CIPN symptoms for > two months. Randomization was used to eliminate bias in patient selection for ALTENS and was not to compare the effectiveness between the two treatments. ALTENS treatments were delivered using Codetron units. Bilateral acupuncture points included LI4 and LIV3, plus LI11 or ST36 were stimulated. Acupuncture treatments were administered to CV6, SP6, ST6, LI11, Bafeng, Baxie and selective Jing points bilaterally. Twelve treatments were delivered twice weekly over 6 to 8 weeks. The Modified Total Neuropathy Score (mTNS), Numbness Score, and Edmonton Symptom Assessment Score (ESAS) were assessed at baseline, treatment completion, plus at 3 and 6 months follow-up. The primary study endpoint was mTNS score at 6 months. We planned to recruit 23 patients into each group. After 30 patients were recruited, 2 were lost to follow-up at 3 months in the ALTENS group and 3 in the acupuncture group. The research team decided to recruit all remaining consecutive patients only to the ALTENS group to ensure an adequate evaluation of ALTENS, the primary object of evaluation. There were 27 patients in the ALTENS group, with an average symptom duration of 10 months after chemotherapy. Twenty four and 23 patients completed the 3 and 6 month followup respectively. The median mTNS scores were 7.1, 4.0, 3.6 and 3.1 at baseline, treatment completion, 3 and 6 months follow-up, respectively. One-way ANOVA analysis showed a significant improvement in mTNS scores (p<0.001) at 6 months. Numbness scores were also significantly improved at 6 months. ESAS pain scores and perception of well-being scores analyses were inconclusive. There were no significant reported side effects of ALTENS. There were only 13 patients in the acupuncture group and the number was insufficient for either an independent or a comparative analysis. The results of this study suggests that ALTENS significantly reduces the mTNS scores and numbness in patients suffering from CIPN symptoms.

Contribution of Loss of Large Fiber Function to Pain in 2 Samples of Oncology Patients

“…Consistent with our a priori hypothesis, this study is the first to demonstrate relationships with both subjective and objective measures of loss of large diameter myelinated fiber function and higher pain severity scores in two independent samples of individuals who were experiencing neuropathic pain following receipt of neurotoxic CTX or breast cancer surgery. While the findings from a small number of pilot studies suggest that the use of TENS-like treatments results in decreases in neuropathic symptoms in patients with CIN 32,33 and post-mastectomy pain, 34 in another pilot randomized controlled trial, 35 TENS had no effect on the pain associated with CIN. In addition, the authors of a recent Cochrane review concluded that definitive conclusions regarding the efficacy of TENS for various types of neuropathic pain could not be determined because the quality of the evidence was very low.…”

A Randomized Assessor-Blinded Wait-List-Controlled Trial to Assess the Effectiveness of Acupuncture in the Management of Chemotherapy-Induced Peripheral Neuropathy

“… 7 In this clinical area of limited treatment options, acupuncture may be considered for treating CIPN, with small-scale pilot studies (N < 30) or case series providing some initial evidence of effect, particularly in decreasing neuropathic pain. 8 - 14 A systematic review identified 3 such trials, which all used a different approach (acupuncture, auricular acupuncture, and acupuncture with moxibustion). 15 Although these mostly uncontrolled or underpowered studies are positive and encouraging, they suggest that acupuncture could be an option for these patients and that controlled trials using validated patient-reported outcome measures are justified.…”

Evidence Based Complementary Approaches in the Management of Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients

“…Bu durum bireyin günlük aktiviteleri ve yaşam kalitesini olumsuz etkilemekte ve hatta bazen tedavinin sonlandırılmasına neden olmaktadır. (10,11) Geçmişten günümüze kemoterapi ile ilişkili nöropatinin yönetiminde farmakolojik ve non-farmakolojik birçok yaklaşım uygulanmıştır. Non-farmakolojik yaklaşımlar arasında akupunktur, refleksoloji, masaj, ayak banyosu, kriyoterapi, scrambler terapi, fiziksel aktivite gibi pek çok tamamlayıcı yaklaşımın etkinliği değerlendirilmiştir.…”

“…Tedavi sonrası, 3. ve 6. aylarda yapılan değerlendirmelerde ALTENS 'in nöropati ile ilişkili semptomların yönetiminde etkili bir yaklaşım olduğu tespit edilmiştir. (11) Farklı bir çift-kör randomize kontrollü çalışmada kemoterapiye bağlı nöropati gelişen hastalarda bir gruba TENS uygulaması yaparken diğer gruba ise plasebo olarak farklı bir yere uygulamıştır. TENS uygulaması 15 günlük periyodlar şeklinde her gün, günde 60 dk olacak şekilde 3 siklus yapılmış ve nöropati semptomlarında herhangi bir iyileşme sağlamadığı görülmüştür.…”