Effect of Sonifilan on Quality of Life in Cervical Cancer Patients During Treatment
The Impact of Sonifilan on the Quality of Life in Patients With Cervical Cancer
This study is testing if Sonifilan can improve the quality of life for women with cervical cancer who are receiving radiation or chemotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT01926821 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of Sonifilan on the quality of life of patients with cervical cancer undergoing radiation or chemoradiation therapy. It is a prospective randomized controlled trial that includes patients with FIGO stage IA2-IVA cervical cancer, specifically those with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Participants will receive Sonifilan injections weekly for eight weeks alongside standard chemotherapy and radiation treatment. The study will assess quality of life and complications related to Sonifilan at various points throughout the treatment and follow-up period.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-75 with FIGO stage IA2-IVA cervical cancer and specific histologic types.
Not a fit: Patients with a history of radiation therapy, other concurrent cancers, or uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life for cervical cancer patients undergoing radiation therapy.
How similar studies have performed: Other studies have explored similar interventions, but the specific use of Sonifilan in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cervical cancer FIGO stage IA2 - IVA * Histologic type : SCC, Adenocarcinoma, Adenosquamous carcinoma * GOG performance status 0-2 Exclusion Criteria: * past radiation therapy history * Neuroendocrine carcinoma * concurrent other cancer * uncontrolled medical disease * ulcerative disease history * current pregnancy and lactation
Where this trial is running
Seoul
- JongHyeokKim — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: WooSuk Han, Master
- Email: bronx46@hotmail.com
- Phone: 82-10-4818-9296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.