Peripheral Neuropathy, Chemotherapy-induced, Disease Management
Conditions
Keywords
Vitamin B, Paclitaxel-induced peripheral neuropathy, Ovarian cancer, Diabetic, Gabapentin
Brief summary
The goal of this clinical trial is to learn if vitamin B prophylaxis is effective in attenuating chemotherapy-induced peripheral neuropathy in adult ovarian cancer patients. The main questions (primary outcomes) it aims to answer are: * The severity of chemotherapy-induced peripheral neuropathy in ovarian cancer patients undergoing a weekly paclitaxel-based regimen in the vitamin B prophylactic group versus non-prophylactic group. * Severity of chemotherapy-induced peripheral neuropathy in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups. Participants will: Take drug oral vitamin B complex every day as prophylaxis for 6 months. Visit the clinic once every week for their weekly Paclitaxel regimen, checkups and tests. Keep a diary of their symptoms.
Detailed description
Patients received oral vitamin B complex as prophylaxis prior to starting their paclitaxel-based regimen and patients in the non-prophylaxis group received oral vitamin B complex upon developing chemotherapy-induced peripheral neuropathy during their treatment with paclitaxel-base regimen. Gabapentin was given to the patients in either groups upon aggravation of CIPN symptoms whether in severity or neuropathic pain according to peripheral neuropathy grading. Secondary outcomes: * The number of patients in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in CIPN with vitamin B complex only. * Impact of vitamin B complex prophylaxis on dose modification of paclitaxel-based regimen. * Association between dose modification and CA 125 status. * Progression-free survival (PFS) was evaluated at the end of the study.
Interventions
DIETARY_SUPPLEMENTVitamin B Complex
Vitamin B complex given as prophylaxis in prophylactic arm and as treatment in non-prophylactic arm.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients with confirmed pathology of ovarian adenocarcinoma. * Aged 18 years or older. * Scheduled to receive a weekly paclitaxel-based chemotherapy regimen (80 mg/m²).
Exclusion criteria
* Individuals under 18 years of age. * Any patients with pre-existing peripheral neuropathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade) | At baseline and up to 18 weeks. | The primary outcome of this study was the severity of chemotherapy-induced peripheral neuropathy in ovarian cancer patients undergoing a weekly paclitaxel-based regimen in the vitamin B prophylactic group versus non-prophylactic group. Severity was assessed by assessed by CTCAE v4.0 through monitoring the occurrence of peripheral neuropathy symptoms (peripheral neuropathy grade) at baseline and on weekly basis, up to 18 weeks (last follow up for chemotherapy induced peripheral neuropathy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of chemotherapy-induced peripheral neuropathy (peripheral neuropathy grade) as assessed by CTCAE v4.0 in diabetic patients versus non-diabetic patients in both prophylactic and non-prophylactic groups. | At baseline and up to 18 weeks. | — |
| Number of participants with paclitaxel induced peripheral neuropathy as assessed by CTCAE v4.0 in both prophylactic and non-prophylactic groups who required Gabapentin upon uncontrolled or aggravation in neuropathy grade with vitamin B complex only. | After the first week and up to 18 weeks. | — |
| Percentage of patients that underwent dose modification in their paclitaxel regimen in both prophylactic and non-prophylactic groups due to chemotherapy-induced peripheral neuropathy as assessed by CTCAE v4.0. | After the first week and up to 18 weeks. | — |
| Association between dose modification in paclitaxel regimen and CA125 status as measured by improved or worsened CA125 status. | up to 20 weeks. | The CA125 status after dose modification in paclitaxel regimen due to chemotherapy-induced peripheral neuropathy or other hematological toxicities. |
| Progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks. | — |
Countries
Egypt
Outcome results
None listed