Cervix Cancer
Conditions
Keywords
Chemo-Radiotherapy, Alendronate, Cancer of the Cervix
Brief summary
Primary Objective \- Proof of concept: To evaluate the efficacy of alendronate in preventing pelvic insufficiency fractures (PIFs) in cervical cancer patients treated with chemo-radiotherapy over the short and long term. This objective will assess both the immediate and sustained effects of the drug on bone integrity through periodic bone mineral density measurements and clinical assessment of fracture incidence. Secondary Objectives * To assess the safety and tolerability of alendronate: This will involve monitoring and documenting any acute and chronic side effects associated with alendronate use in this patient population, including but not limited to gastrointestinal issues, renal function impairment, and osteonecrosis of the jaw. * To document and analyze changes in quality of life: Using validated quality of life instruments, this objective will track changes in patient-reported outcomes, focusing on aspects such as pain levels, physical function, and overall well-being. This will help determine if the intervention not only prevents fractures but also contributes positively to the patients' quality of life during and after treatment. * To explore correlations between patient-specific factors and treatment efficacy: This objective aims to understand how variables such as age, cancer stage, previous treatment history, and baseline bone health might influence the effectiveness of alendronate in preventing PIFs and enhancing bone mineral density.
Detailed description
Primary Objective \- Proof of concept: To evaluate the efficacy of alendronate in preventing pelvic insufficiency fractures (PIFs) in cervical cancer patients treated with chemo-radiotherapy over the short and long term. This objective will assess both the immediate and sustained effects of the drug on bone integrity through periodic bone mineral density measurements and clinical assessment of fracture incidence. Secondary Objectives * To assess the safety and tolerability of alendronate: This will involve monitoring and documenting any acute and chronic side effects associated with alendronate use in this patient population, including but not limited to gastrointestinal issues, renal function impairment, and osteonecrosis of the jaw. * To document and analyze changes in quality of life: Using validated quality of life instruments, this objective will track changes in patient-reported outcomes, focusing on aspects such as pain levels, physical function, and overall well-being. This will help determine if the intervention not only prevents fractures but also contributes positively to the patients' quality of life during and after treatment. * To explore correlations between patient-specific factors and treatment efficacy: This objective aims to understand how variables such as age, cancer stage, previous treatment history, and baseline bone health might influence the effectiveness of alendronate in preventing PIFs and enhancing bone mineral density.
Interventions
the Use of Alendronate to Reduce the Risk of Developing Pelvic Insufficiency Fractures in Patients with Cancer of the Cervix Treated with Chemo-Radiotherapy
Sponsors
Dr. Itay GoorAryeh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age: Patients must be 18 years of age or older. * Diagnosis:Patients diagnosed with non-metastatic cervical cancer stages IB2 to IVA, as per the FIGO staging system. * Treatment Plan: Patients scheduled to undergo definitive chemo-radiotherapy or adjuvant chemo-radiotherapy post-surgery. * Bone Health: No history of osteoporosis or previous treatment with bisphosphonates or other bone-modifying agents. * Pain Assessment: Patients experiencing bone pain or at risk of developing pelvic insufficiency fractures, despite current standard of care. * Recent Imaging: Patients must have undergone recent imaging (CT, PET, or MRI) within the last 3 months to confirm the absence of bone metastases. * Compliance: Patients must be able to comply with the study protocol and follow-up schedule. Psychological, familial, sociological, or geographical conditions that could hamper compliance need to be evaluated and discussed before trial registration. * Consent: Patients must provide written informed consent before participating in the study
Exclusion criteria
Age: Patients under 18 years of age. * Performance Status: Patients with an ECOG Performance Status of 2, 3 or 4. * Bone Metastases: Presence of bone metastases. * Contraindications to Alendronate: Known contraindications to alendronate, such as esophageal disorders, inability to sit or stand upright for at least 30 minutes, severe renal impairment (creatinine clearance \<35 mL/min), or hypersensitivity to any component of the product. * Concurrent Treatments: Patients receiving other concurrent treatment with bisphosphonates, denosumab, or other bone-modifying agents. * Special Populations: Pregnant or breastfeeding women, prisoners, and patients with major psychiatric illnesses that could interfere with adherence to study requirements. * Previous Treatment: Patients who have previously received radiotherapy to the pelvic region.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Pre -treatment, 5,12 and 24 months post-initiation of therapy | Use of the numeral rating scale for pain |
| Quality of life | Pre -treatment and 5,12 and 24 months post-initiation of therapy | Use of QLQ-C30 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density | Pre-treatment, 1 year and 2 years post-treatment | DXA Scan |
| Blood tests for markers of bone turnover | Pre-treatment | Calcium and vitamin D levels, CTX(serum C terminal telopeptide),P1NP, Albumin-adjusted Calcium levels, Phosphorus, Estradiol and FSH |
Contacts
Primary ContactAkram Saad, Dr
Outcome results
None listed