Trial of surgical gloves for prevention of oxaliplatin-induced peripheral neuropathy

JRCT ID: jRCTs062240066

Registered date:08/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chemotherapy-induced peripheral neuropathy
• Date of first enrollment: 08/10/2024
• Target sample size: 170
• Study type: Interventional
• Intervention(s): From 30 minutes before the start of chemotherapy treatment until 30 minutes after the end of treatment, a surgical glove one size smaller than the just fit size is worn in a double layer. Emblem surgical gloves latex-free manufactured by Sanko Chemical Industry Co. will be used for this study.

Outcome(s)

• Primary Outcome: Rate of peripheral neuropathy incidence of Grade 2 or higher (CTCAE Ver. 5.0)
• Secondary Outcome: FACT/GOG-Ntx-12, EORTC QLQ-CIPN20, DEB-NTC, completion rate of adjuvant chemotherapy, relative dose intensity of adjuvant chemotherapy, number of courses with oxaliplatin, relative dose intensity of oxaliplatin, chemotherapy adverse events other than peripheral neuropathy, surgical globe safety, Peripheral Sensory Neuropathy (peripheral neuropathy)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with Stage III colorectal cancer diagnosed histologically according to the "9th Edition of the Japanese Colorectal Cancer Code"
(2) Patients who have undergone colorectal resection including systematic lymph node dissection
(3) Patients who have undergone radical A surgery (no residual tumor either grossly or microscopically)
(4) Patients scheduled to receive 8 courses of postoperative adjuvant chemotherapy with oxaliplatin (CAPOX) at the time of enrollment
(5) Patients who can be enrolled within 8 weeks after resection of the primary tumor and who can start CAPOX therapy within 2 weeks after enrollment
(6) Patients who are at least 18 years old and whose written consent can be obtained
(7) Patients with ECOG PS 0 or 1
(8) Patients who have signed and dated written consent to participate in the study before enrollment in the study

Exclude criteria

(1) Patients with peripheral neuropathy presenting with severe sensory or perceptual dysfunction with functional impairment or concomitant central neuropathy
(2) Patients receiving drugs that may affect peripheral neuropathy (acetyl-L-carnitine, vitamin E, glutamine, gabapentin, tricyclic antidepressants, opioid drugs)
(3) Patients with a history of hypersensitivity to oxaliplatin or other platinum-containing drugs
(4) Patients with concomitant psychiatric disorders to a degree that would affect the efficacy or safety evaluation of this study
(5) Patients previously treated with systemic chemotherapy (including investigational agents) or radiation therapy for antitumor effects
(6) Patients with active multiple cancers*1
(7) Patients who have not recovered from surgery and complications such as postoperative infection
(8) Patients with serious intestinal obstruction, diarrhea, or fever
(9) Patients with hepatitis B who test positive for HBs antigen (However, if the patient is negative for HBs antigen but positive for either HBc or HBs antibody, an HBV-DNA test will be performed and if it is above the standard value, the patient will not be eligible for inclusion. (In addition, test data within 6 months prior to the date of registration may be used.)
(10) Patients who are positive for either HIV antigen or HIV antibody
(11) Pregnant or possibly pregnant patients, male or female patients who do not intend to use contraception during the study period, and lactating patients
(12) Patients who meet any of the following criteria for major organ function (laboratory values should be the most recent values within 14 days prior to enrollment)
1. White blood cell count less than 2000/mm3 or neutrophil count less than 1000/mm3
2. Platelet count less than 100,000/mm3
3. Hemoglobin level less than 9.0 g/dL
4. AST or ALT is more than 100 IU/L (5) Serum creatinine is more than 100 IU/L
5. Serum creatinine is 1.5 times or more than the facility standard value
(13) Patients with hand sizes that feel that a size 5 surgical glove fits just right or is too large
(14) Other patients deemed inappropriate for this study by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Ohdan Hideki
• Secondary Sponsor: Hiroshima University, Hiroshima Surgical study group of Clinical Oncology (HiSCO)