Oral Vitamin B12 Versus Placebo for the Prevention of Chemotherapy-induced Peripheral Neuropathy in Gynecological Cancer Patients: A Randomized, Double-blind, Placebo Controlled Trial

Phase 3

Completed

• Conditions: 1. Chemotherapy-induced peripheral neuropathy (CIPN)2. Adverse event from vitamin B 12 or placebo3. Quality of life improvement; Oral vitamin B 12; Chemotherapy induced peripheral neuropathy; Gynecological cancer; Neurotoxic chemotherapy

• Registration Number: TCTR20210104003
• Lead Sponsor: Rajavithi hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Study Completion: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1.Women aged 18 to 70 years who diagnosed with a histological or cytological confirmed gynecologic malignancy such as ovarian cancer, endometrial cancer, cervical cancer, and vulvar cancer
2.Receive first cycle of chemotherapy with platinum derivatives (cisplatin and carboplatin), taxanes (paclitaxel and docetaxel), or vinca alkaloids (vincristine and vinblastine)
3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4.Adequate bone marrow, kidney and liver functions (hemoglobin more than or equal 10 g/dL, leukocyte count more than or equal 3000/mL, absolute neutrophil count more than or equal 1500/mL, platelet count more than or equal 100 000/mL,serum creatinine less than or equal 1.5 mg/dL, bilirubin less than or equal 1.5 upper limit of normal, alkaline phosphatase and serum glutamic oxaloacetate transaminase less than or equal 3 upper limit of normal)
5.Able to speak, read, and understand Thai language

Exclusion Criteria

1. The patients who had History of peripheral neuropathy from any causes
2. Previous received neurotoxic chemotherapy
3. Currently consumed vitamins or nutritional supplements
4. The patients who was vegetarian
5. Mean corpuscular volume from laboratory investigation more than 100 fL o
6. Cognitive impairment or severe mental illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of chemotherapy-induced peripheral neuropathy (CIPN) 4 time points. First before start chemotherapy and repeat at cycle 3 ,6 and 4 weeks after completion of chemotherapy Patient neurotoxicity questionnaire (PNQ) score

Secondary Outcome Measures

Name	Time	Method
The occurrence and severity of adverse events from vitamin B 12 and placebo e 1 week after medication use Quesionaire,Evaluate the quality of life improvement 4 time points. First before start chemotherapy and repeat at cycle 3 ,6 and 4 weeks after completion of chemotherapy Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx) questionnaire