HiSCO-12 Trial

Cross-source consensus on HiSCO-12 Trial from 1 sources and 7 claims.

1 sources · 7 claims

Risks & contraindications

Other

Highlighted claims

The trial assumes a 36% CIPN incidence in the control group and a 15% incidence in the intervention group. — Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial
To detect the hypothesised reduction with 80% power at 5% significance and allowing 10% dropout, the trial requires 170 participants with 85 per group. — Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial
No interim analysis is planned for the HiSCO-12 trial. — Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial
The HiSCO-12 trial is a multicentre, randomised, open-label, phase II/III controlled trial comparing surgical glove compression therapy with standard care for prevention of OIPN. — Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial
The trial will be conducted at 16 institutions affiliated with the Hiroshima Surgical Study Group of Clinical Oncology in Japan. — Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial
The trial is open-label because wearing tight surgical gloves is obvious to participants, making true blinding impractical, which creates a risk of reporting bias. — Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial
The trial does not include neurophysiological tests, quantitative sensory testing, or physiological measurements, so it cannot directly explain the biological mechanism of any preventive effect. — Possible preventive effect of surgical glove compression therapy on oxaliplatin-induced peripheral neuropathy: study protocol of a multicentre, phase II/III, randomised controlled trial–the Hiroshima Surgical Study Group of Clinical Oncology (HiSCO)-12 trial