1. Chemotherapy-induced peripheral neuropathy (CIPN) 2. Adverse event from vitamin B 12 or placebo 3. Quality of life improvement Oral vitamin B 12 Chemotherapy induced peripheral neuropathy Gynecological cancer Neurotoxic chemotherapy
Conditions
Interventions
the patients received 2000 micrograms of cyanocobalamin per day divided in 2 tabs of 500 micrograms bid after meals,the patients received 2 tabs of placebo bid after meals
Experimental Drug,Placebo Comparator No treatment
vitamin B 12,Placebo
Sponsors
Rajavithi hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactTrinya Chaiwongsa
Rajavithi hospital
Outcome results
None listed