Recovery and Quality of Life in Cervical Cancer Patients Using Vaginal Dilators After Radiotherapy

NCT07698795 | Completed DMC

• 1 other identifier: 070/2562
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cervical Cancer Radiation Complications; QoL

Keywords

Cervical Cancer; Radiotherapy; Brachytherapy; Quality of Life (QoL); Vaginal Dilator

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life (QoL) Scores

  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.

  Data is collected at six specific intervals: Baseline (pre-treatment), and then at 1, 3, 6, 9, and 12 months post-treatment.

Study Arms (1)

Quality of Life (QoL)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participation in this study is restricted to individuals who self-identify as female. This eligibility criterion is defined by the study's focus on cervical cancer and the management of post-radiotherapy complications specific to this population, such as vaginal contraction and stenosis. The clinical and demographic data for the study cohort confirm that all 67 participants were women, with assessments covering sex-specific health indicators including pregnancy history, methods of childbirth, and menopausal status. Because the primary objective is to evaluate the impact of a vaginal dilator device on maintaining anatomical integrity and improving quality of life following definitive radiation for cervical cancer, only individuals with the relevant biological and clinical profile are eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 67 women. All participants were diagnosed with cervical cancer and had completed definitive radiation therapy, specifically a combination of External Beam Radiation Therapy (EBRT) and Intracavitary Radiation Therapy (ICRT/Brachytherapy). This cohort was followed longitudinally for 12 months post-treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulabhorn Cancer Center: lead

Study Sites (1)

Chulabhorn Hospital, Chulabhorn Royal Academy

Bangkok, 10210, Thailand

Location

Related Publications (12)

• Xu 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 BACKGROUND

• Torigoe 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 BACKGROUND

• Sheikh-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 BACKGROUND

• Morris 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 BACKGROUND

• Mizutani 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 BACKGROUND

• Liu 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 BACKGROUND

• Hussey C, Hanbridge M, Dowling M, Gupta A. Cancer survivorship: understanding the patients' journey and perspectives on post-treatment needs. BMC Sports Sci Med Rehabil. 2024 Apr 12;16(1):82. doi: 10.1186/s13102-024-00864-y.

  PMID: 38605386 BACKGROUND

• Hou P, Hsieh C, Wei M, Hsiao S, Shueng P. Differences in Treatment Outcomes and Prognosis between Elderly and Younger Patients Receiving Definitive Radiotherapy for Cervical Cancer. Int J Environ Res Public Health. 2020 Jun 23;17(12):4510. doi: 10.3390/ijerph17124510.

  PMID: 32585933 BACKGROUND

• Heyman Y, Rojlar H, Hawranek C, Numan Hellquist B, Rosen A. Quality of life, anxiety and cancer worry following hereditary cancer testing: a 6-month Swedish follow-up study. Qual Life Res. 2026 Feb 12;35(3):70. doi: 10.1007/s11136-026-04184-1.

  PMID: 41677932 BACKGROUND

• Gupta IJ, Ghosh A, Yadav J, Tuteja JS, Gupta R, Srivastava K, Verma M, Gupta S, Srivastava S, Bhatt MLB. External Beam Radiotherapy Interdigitated with High Dose Rate(HDR) Intracavitary Brachytherapy versus External Beam Radiotherapy followed by Sequential HDR Intracavitary Brachytherapy for Locally Advanced Carcinoma Cervix-Randomized Control Study. Asian Pac J Cancer Prev. 2023 Oct 1;24(10):3441-3445. doi: 10.31557/APJCP.2023.24.10.3441.

  PMID: 37898849 BACKGROUND

• Damast S, Jeffery DD, Son CH, Hasan Y, Carter J, Lindau ST, Jhingran A. Literature Review of Vaginal Stenosis and Dilator Use in Radiation Oncology. Pract Radiat Oncol. 2019 Nov;9(6):479-491. doi: 10.1016/j.prro.2019.07.001. Epub 2019 Jul 11.

  PMID: 31302301 BACKGROUND

• Amies Oelschlager AM, Debiec K. Vaginal Dilator Therapy: A Guide for Providers for Assessing Readiness and Supporting Patients Through the Process Successfully. J Pediatr Adolesc Gynecol. 2019 Aug;32(4):354-358. doi: 10.1016/j.jpag.2019.05.002. Epub 2019 May 12.

  PMID: 31091469 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Saengrawee Thanthong, PhD

  Chulabhorn Royal Academy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: April 3, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)