Clinical trial · Observational
Recovery and Quality of Life in Cervical Cancer Patients Using Vaginal Dilators After Radiotherapy
Impact of Vaginal Dilator Use on Vaginal Morbidity and Quality of Life Following Definitive Radiation Therapy for Cervical Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this longitudinal observational study is to understand the trajectory of Quality of Life (QoL) recovery in women with cervical cancer who have received definitive radiation therapy. The main questions it aims to answer are: Do functional domains, such as physical, role, and social functioning, show significant and sustained improvement over the 12 months following treatment? How does the burden of treatment-related symptoms, including fatigue, nausea, and cervical cancer-specific symptoms, resolve during the one-year recovery period? Researchers will analyze changes in QoL scores over time to identify which clinical factors-such as time elapsed since treatment and baseline disease stage-serve as the most significant predictors of a patient's overall well-being. Participants will: * Complete standardized Quality of Life assessments using the EORTC QLQ-C30 and the cervical cancer-specific QLQ-CX24 instruments. * Provide data at six specific intervals: baseline (pre-treatment) and at 1, 3, 6, 9, and 12 months post-radiotherapy. * Report on multiple functional scales, including physical, role, emotional, cognitive, and social status. * Monitor and report symptom levels for various issues such as fatigue, pain, nausea, and sexual/vaginal functioning.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Radiation Complications | — | UNRESOLVED | — |
| QoL | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Quality of Life (QoL)
- description
- This longitudinal cohort includes 67 women treated for cervical cancer. All participants received definitive External Beam Radiation Therapy (EBRT) and Brachytherapy (ICRT). The intervention focuses on the Quality of Life (QoL). Recovery was tracked at baseline and 1, 3, 6, 9, and 12 months post-treatment using EORTC QLQ-C30 and QLQ-CX24.
Primary outcomes (1)
- measure
- Change in Quality of Life (QoL) Scores
- timeFrame
- Data is collected at six specific intervals: Baseline (pre-treatment), and then at 1, 3, 6, 9, and 12 months post-treatment.
- description
- This outcome assesses the longitudinal trajectory of a patient's overall health status, functional abilities, and symptom burden following radiotherapy. Assessment Tools: QoL is measured using two standardized instruments: the EORTC QLQ-C30 (30-item core questionnaire for general cancer patients) and the EORTC QLQ-CX24 (24-item module specific to cervical cancer). Scoring: All scales and single-item measures are transformed to a 0 to 100 scale. For the Global Health Status and functional scales (Physical, Role, Social, Emotional, and Cognitive), higher scores represent a higher/better level of functioning. For symptom scales (such as Fatigue, Pain, and Nausea), higher scores represent a higher level of symptom burden or distress.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A confirmed diagnosis of cervical cancer, including various histological types such as Squamous cell carcinoma (85.07%), Adenocarcinoma (13.43%), or Small cell carcinoma. * Completion of definitive radiation therapy, specifically the combination of External Beam Radiation Therapy (EBRT) and Intracavitary Radiation Therapy (ICRT/Brachytherapy). * Participants identified as female. * Patients were included across clinical stages I through IV, with Stage IIIC1 being the most common (28.79%). * Willingness to participate in a 12-month longitudinal study involving assessments at six distinct time points: baseline (pre-treatment) and 1, 3, 6, 9, and 12 months post-radiotherapy. Exclusion Criteria: * Presence of lesions that make it impossible to use the vaginal dilator device. * Chronic or severe bleeding that prevents the safe or effective use of the vaginal dilator. * Emergency medical conditions or a clinical necessity for alternative treatments following the initial radiation therapy. * Inability to attend follow-up visits or comply with the monitoring guidelines established in the study protocol. Additionally, the sources define discontinuation criteria for participants who have already entered the study: * The participant requests to withdraw from the project for any reason. * The participant receives incomplete treatment due to the progression or specific nature of the disease.
References
Publications (12)
- BACKGROUNDXu Z, Traughber BJ, Fredman E, Albani D, Ellis RJ, Podder TK. Appropriate Methodology for EBRT and HDR Intracavitary/Interstitial Brachytherapy Dose Composite and Clinical Plan Evaluation for Patients With Cervical Cancer. Pract Radiat Oncol. 2019 Nov;9(6):e559-e571. doi: 10.1016/j.prro.2019.06.003. Epub 2019 Jun 22. PMID 31238167
- BACKGROUNDTorigoe R, Dennen C, Mayadev J, Makale MT. Current challenges in the assessment and management of radiotherapy-induced vaginal stenosis. Int J Gynecol Cancer. 2026 Jan;36(1):102801. doi: 10.1016/j.ijgc.2025.102801. Epub 2025 Nov 17. PMID 41317693
- BACKGROUNDSheikh-Wu SF, Anglade D, Downs CA. A cancer survivorship model for holistic cancer care and research. Can Oncol Nurs J. 2023 Jan 1;33(1):4-16. doi: 10.5737/236880763314. eCollection 2023 Winter. PMID 36789222
- BACKGROUNDMorris L, Do V, Chard J, Brand AH. Radiation-induced vaginal stenosis: current perspectives. Int J Womens Health. 2017 May 2;9:273-279. doi: 10.2147/IJWH.S106796. eCollection 2017. PMID 28496367
- BACKGROUNDMizutani T, Takei H, Kunitoh H, Wakabayashi M, Sekino Y, Tsuboi M, Ikeda N, Asamura H, Okada M, Takahama M, Ohde Y, Okami J, Shiono S, Aokage K, Watanabe SI; Lung Cancer Surgical Study Group of the Japan Clinical Oncology Group, Japan. Longitudinal assessment of functional independence of older adults after lung cancer surgery: Final results of the JCOG1710A prospective cohort study. J Geriatr Oncol. 2025 Jul;16(6):102268. doi: 10.1016/j.jgo.2025.102268. Epub 2025 May 30. PMID 40449074
- BACKGROUNDLiu M, Lv Z, Xing S, Yi H, Wang L, Wang S, Liu L, Li N. Decision conflict, psychological resilience, and financial toxicity in early-stage non-small cell lung cancer in China: A latent profile and mediation analysis. Asia Pac J Oncol Nurs. 2026 Feb 26;13:100929. doi: 10.1016/j.apjon.2026.100929. eCollection 2026 Dec. PMID 42039773