Comparing Two Chemotherapy Treatments for Ovarian Cancer: Albumin-Bound vs. Solvent-Based Paclitaxel-Carboplati
Phase 4
- Conditions
- Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2024/05/067283
- Lead Sponsor
- Pharmacology Department Paraclinical Block Dr RPGMC Kangra at Tanda HP India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Willing adult patient giving written informed consent. Karnofsky Performance Scale (KPS) =70
No medical co-morbidities like DM, HTN Normal routine blood investigations.
The study will include all the newly diagnosed consenting patient of stage Ic- IV ovarian cancer patient.
Exclusion Criteria
Known case of DM or HTN or any neuropathic disorder. Patient not willing to give written informed consent.
Pregnant and Lactating females.
Patient already on treatment with study drug.
Patients with known contraindication or refractoriness to study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare safety and efficacy of albumin bound paclitaxel and solvent based paclitaxel and disease-free survival in ovarian cancer patients. <br/ ><br>Comparison of safety & efficacy based on adverse drug reactions & treatment outcome/disease prognosis respectively in individual groups based on statistical analysis after data collection is complete.Timepoint: Follow-ups will be done at 3, 6, 9 months and at 1 year. <br/ ><br>After finishing data collection, results will be declared using statistical analysis to bring-out the evidence on safety & efficacy between the two groups.
- Secondary Outcome Measures
Name Time Method To compare quality of life & overall survival, lowering hospital-based depression & neurotoxicity of chemotherapy patients of individual groups based on the data collected in required questionnaires. This will be elicited after the statistical analysis of the questionnaire data. <br/ ><br>Timepoint: Follow-ups will be done for questionnaires of quality of life & overall survival, lowering hospital-based depression & neurotoxicity at baseline, 6 months & after 1-year of enrolment. After data entry into the excel sheets, the results will be statistically derived.