Effectiveness and safety of surgical glove compression therapy as a prophylactic method against nanoparticle albumin-bound-paclitaxel-induced peripheral neuropathy

Tsuyuki, Shigeru; Yamagami, Keiko; Yoshibayashi, Hiroshi; Sugie, Tomoharu; Mizuno, Yutaka; Tanaka, Satoru; Kato, Hironori; Okuno, Toshitaka; Ogura, Nobuko; Yamashiro, Hiroyasu; Takuwa, Haruko; Kikawa, Yuichiro; Hashimoto, Takashi; Kato, Takehito; Takahara, Sachiko; Katayama, Toshiro; Yamauchi, Akira; Inamoto, Takashi

doi:10.1016/j.breast.2019.06.008

Cited by 23 publications

(23 citation statements)

References 12 publications

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“…Fourth, the studies seemed to differ with regard to the measurement of glove size. In our study, 34.7% of patients required a size 5.0 glove for the study side, although no patient in the previous studies required this size [7,20]. Since all three studies were performed in Japan, we believe that there was no substantial difference in patients' physiques.…”

Section: Discussionmentioning

confidence: 56%

“…Second, the studies differed in design, albeit that the method of compression therapy was same. Following the rst report, which con rmed effectiveness by using gloves on the dominant hand only, they also con rmed the effectiveness by wearing gloves on both hands [20]. Neither study designs allowed the exclusion of performance bias and detection bias due to the lack of blinding of patients and physicians.…”

Section: Discussionmentioning

confidence: 99%

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Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial 

Kotani

Terada

Mori

et al. 2020

Preprint

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Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of paclitaxel (PTX). There is no known prophylactic measure, although there are some reports of prevention with compression therapy using surgical gloves. On account of its predominantly subjective symptoms, it is difficult to exclude bias when assessing for CIPN. In this study, we assessed the effectiveness of the same procedure for the prevention of paclitaxel-induced PN based on a double-blind study design.Methods: The patients with early and recurrent breast cancer (with no prior PTX exposure) initiating weekly chemotherapy with PTX 80 mg/m2 were enrolled. Each patient donned two gloves on each hand at every PTX infusion. Two one-size-smaller gloves were donned on one hand (study side) and two normal-size gloves were donned on the other hand (control side) during 90 minutes from 30 minutes before the infusion to 30 minutes after the end of the infusion. Study side are blind for both patients and assessing physicians according to determination of the study side by research nurses in the chemotherapy unit.The primary outcome was the difference in the frequency of CIPN (motor/sensory) determined by the physician using the common terminology criteria for adverse events (CTCAE v4.0), with an evaluation at each cycle of PTX infusion. McNemar test was used to assess the primary outcome.Results: Between July 2017 and November 2018, 56 patients were enrolled and 49 patients were evaluated. Overall, Grade ≥ 2 PN (sensory) was observed in 30.6% and 36.7% in the study and control sides, respectively (McNemar p = 0.25). PN (motor) was observed in 4.1% and 6.1% in the study and control sides, respectively (McNemar p = 1.0). Conclusion: Surgical glove compression therapy showed no statistically significant effect on the incidence of PTX-induced PN.Trial registrations: This study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry managed by the National University Hospital Council of Japan (UMIN000027944).

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Section: Discussionmentioning

confidence: 56%

Section: Discussionmentioning

confidence: 99%

Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial 

Kotani

Terada

Mori

et al. 2020

Preprint

View full text Add to dashboard Cite

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“…The study showed that the overall incidence of grade 2 or higher sensory CIPN, according to CTCAE, with SG compression therapy was low at 13.8%, and the rate was significantly lower than that of the control group in the prior study (44.1%), with a complete absence of grade 3 CIPN over time. 54 Another way to reduce microvascular perfusion is using cold temperature, which is called "therapeutic regional hypothermia" or "cryotherapy." 55,56 Various limb cooling modalities have been used, most of which involve the direct application of ice or frozen gloves and cause rapid cooling gradients with varied and often poor tolerability.…”

Section: Discussionmentioning

confidence: 99%

“…Weekly PTX 53% reduction in pain, 44% reduction in tingling, and a 37% reduction in numbness 47 Surgical glove compression 53,54 Breast cancer Weekly nab-PTX CIPN grade ≥2 (%) after treatment versus that in a control group from the literature • • 13.8 versus 44.1 54 CIPN grade ≥2 (%) after treatment versus that of a control on their contralateral side • • 21.4 versus 76.1 53 Frozen gloves and socks hypothermia 61,63 Breast…”

Section: Declaration Of Conflicting Interestsmentioning

confidence: 99%

Innovative Approach for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Pilot Study With the Hilotherm Device, the Poliambulanza Hospital Experience

et al. 2020

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Background: Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse event of taxanes, with no effective prevention or treatment available and a highly negative impact on patient quality of life. The aim of this study is to asses that the constant application of cooled cuffs on the hands and feet prevent and mitigate CIPN. Methods: Patients with breast, gynecologic, and pancreatic cancer who received weekly paclitaxel (PTX), PTX/carboplatin, and nab-paclitaxel (nab-PTX)/gemcitabine for any indication at the therapeutic scheduled dosage were included in this prospective study. Hilotherm Chemo care device forms a closed-loop system with cuffs and tubes through which a coolant flows at a temperature of 10 °C. CIPN was monitored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (edition 3.0), and the tolerability and side effects were scored by using the Common Terminology Criteria for Adverse Events (T4.03 2017). Results: To date, we have enrolled 64 patients. Of these, 54 (84%) completed all cooling cycles. Continuous cooling was well tolerated by all patients. No patients had grade >2 CIPN or had serious or lasting adverse events as a result of Hilotherapy. The median time to CIPN onset was 77 days for the entire population. Conclusion: Hilotherapy has good effectiveness and tolerability and seems to be able to prevent or reduce the symptoms of CIPN. We are still recruiting patients to obtain more data and to collect data at 3 months after the end of chemotherapy. Prospective studies seem to be warranted.

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“…In recent years, the efficacy of cryotherapy using a frozen glove (FG) [ [12] , [13] , [14] ] and compression therapy using surgical gloves (SGs) [ [15] , [16] , [17] ] to prevent taxane-induced peripheral neuropathy has been reported. SG compression therapy is an easy procedure, inexpensive compared to FG cryotherapy.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the efficacy of cryotherapy and compression therapy for preventing nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: A prospective self-controlled trial

et al. 2020

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Background Recently, the efficacy of cryotherapy and compression therapy to prevent taxane-induced peripheral neuropathy has been reported. We prospectively compared the efficacy of cryotherapy using a frozen glove (FG) and compression therapy using a surgical glove (SG) to prevent nanoparticle albumin-bound paclitaxel (nab-PTX)-induced peripheral neuropathy. Patients and methods Breast cancer patients who received 260 mg/m 2 of nab-PTX were eligible to participate in this trial. Patients wore a FG on one hand (60 min) without changing and two SGs of the same size (i.e., one size smaller than the size that best fit their hand) on the other hand (90 min) during chemotherapy. Peripheral neuropathy was evaluated at each treatment cycle using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, the Patient Neurotoxicity Questionnaire (PNQ), and the Functional Assessment of Cancer Therapy-Taxane subscale. Temperatures at each fingertip in both groups were measured thermographically. Results Between August 2017 and March 2019, 43 patients were enrolled and 38 were evaluated. No cases showed discordance of peripheral neuropathy between each gloved group in cases of CTCAE grade 2. In cases of PNQ grade D, using the Nam equivalence test, the upper test ( P = 0.0329) and lower test ( P = 0.0052) both showed negative results in comparisons between each gloved group. Fingertip temperature was significantly lower in the FG group than in the SG group after treatment ( P < 0.0001). Conclusions It seems to be no difference in incidence of nab-PTX-induced peripheral neuropathy using either cryotherapy or compression therapy.

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Effectiveness and safety of surgical glove compression therapy as a prophylactic method against nanoparticle albumin-bound-paclitaxel-induced peripheral neuropathy

Cited by 23 publications

References 12 publications

Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial

Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial

Innovative Approach for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Pilot Study With the Hilotherm Device, the Poliambulanza Hospital Experience

Comparison of the efficacy of cryotherapy and compression therapy for preventing nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: A prospective self-controlled trial

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Effectiveness and safety of surgical glove compression therapy as a prophylactic method against nanoparticle albumin-bound-paclitaxel-induced peripheral neuropathy

Cited by 23 publications

References 12 publications

Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial&nbsp;

Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial&nbsp;

Innovative Approach for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Pilot Study With the Hilotherm Device, the Poliambulanza Hospital Experience

Comparison of the efficacy of cryotherapy and compression therapy for preventing nanoparticle albumin-bound paclitaxel-induced peripheral neuropathy: A prospective self-controlled trial

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Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial

Compression Therapy Using Surgical Gloves Does Not Prevent Paclitaxel-induced Peripheral Neuropathy: Results From a Double-blind Phase 2 Trial