The aim of the vaginal morbidity sub-study is to better understand the different physical, dosimetric, biological, clinical and psychological factors and to analyse the importance of these factors for patient reported outcome on sexual functioning…
ID
Source
Brief title
Condition
- Cervix disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vaginal changes, reported by patient and radiotherapist, and the complex
interaction of the physical, dosimetric, biological, clinical and psychological
factors to vaginal morbidity and the importance of these factors to sexual
functioning and health related quality of life.
Secondary outcome
1. To comprehensively asses vaginal change related to radiotherapy (vaginal
morbidity) over time as seen or measured at gynaecological examination.
2. To establish a vaginal dosimetry wich enables a radiotherapy dose effect
relationship for physician assessed objective vaginal changes.
3. To investigate if physician recorded 'objective' vaginal changes are
correlated with patient reported vaginal symptoms.
4. To examine if physician recorded 'objective' vaginal changes and/or patient
reported vaginal symptoms are relevant for overall sexual functioning.
5. To evaluate the extent to which general psychological aspects (emotional
sistress, relationship issues, body image, infirtility, fatigue and overall
quality of life) influence sexual functioning.
6. To investigate the influence of clinically established interventions on both
patient reported overall sexual functioning and physician reported vaginal
changes.
Background summary
External beam radiotherapy combined with image guided brachytherapy and
chemotherapy is the normal treatment for advanced stages of cervical cancer.
The ongoing EMBRACE study is an international multicenter prospective phase II
study that investigates the effect of implementation of 3-dimensional image
guided brachytherapy.
Image guided brachytherapy provides better treatment of the tumor, while at the
same time allows better sparing of organs at risk of treatment related side
effects.
Posttreatment sexual diffunction and symptoms are important factors causing
long term distress for an increasing number of cervical cancer survivors.
Study objective
The aim of the vaginal morbidity sub-study is to better understand the
different physical, dosimetric, biological, clinical and psychological factors
and to analyse the importance of these factors for patient reported outcome on
sexual functioning and health related quality of life.
Part of these questions will be answerd in the ongoing EMBRACE study but we
need more detailed information.
These outcome will be relevant to introduce treatment optimisation and help
guide evidence based attempts to improve sexual functioning and reduce
symptoms.
Study design
The vaginal morbidity study is proposed as a sub-study of the ongoing EMBRACE
study. This is an international multicenter prospective phas II study with
routine follow-up time points and planned gynaecological examinations. Also
patients that will not be enrolled in the EMBRACE and EMBRACE Vaginal
Morbidity studie undergo the same treatment (external beam radiotherapy
combined with image guided brachytherapy and chemotherapy) and have the same
follow-up time points at the radiotherapy department.
For thr EMBRACE Vaginal Morbidity Study more detailed reporting of vaginal
changes during clinical examination, more in depth patient reported sexuality
issues and more detailed brachytherapy dose reporting are required.
In a prospective lonitudinal setting, more detailed information on physician
assesed vaginal toxicity and dosimetry will be combined with patient reported
information on vaginal changes, sexual function and psychological factors.
This delailed information will be documented at baseline, before start of
radiotherapy, at follow-up time points of 4-6 weeks and 3,6,12 and 24 months
after the end of treatment.
Assessment of:
1. Vaginal changes during planned gynaecological follow-up exam. To measure
vaginal length and with standard perspex cilinders are used. Measurements at
baseline, 4-6 weeks and 3,6,12 and 24 months after completion of radiotherapy.
2. 16 extra questions, to measure the effect on sexual function, will be added
to the quality of life questionaire.
3. All patients are advised to use vaginal dilators after radiotherapy to
reduce side effects. Patients in this studie are asked about the frequency,
size and compliance of dilation.
4. To correlate vaginal morbidity to the vaginal dose, extra dosepoints will be
added in the radiotherapy treatmentplans (external beam and brachytherapy).
Study burden and risks
Burden and risk of the study is verry low.
Existing EMBRACE quality of life questionnaires have additional items to asses
issues related to sexuality. These questionnaires have the same timepoints as
the existing routine follow-up points and take not more than 15- 20 minutes.
During routine clinical examination(at baseline, before start of radiotherapy,
at follow-up time points of 4-6 weeks and 3,6,12 and 24 months after the end of
treatment) radiation induced vaginal changes (length, with and mucosal aspects)
are measured . These measurements will consume just a minimal extra time during
the regular follow-up.
Spitalgasse 23
Wien 1090
AT
Spitalgasse 23
Wien 1090
AT
Listed location countries
Age
Inclusion criteria
- Cancer of the uterine cervix suitable for curative treatment with definitive radio-(chemo)therapy including 3D image guided Brachytherapy.
- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
- Staging according to FIGO and TNM guidelines
- FIGO stage IB1-IIIB, without vaginal extension (stage IIA and IIIA not allowed)
- Para-aortic metastatic nodes below L1-L2 are allowed
- Patient informed concent
- Ability to read, understand and fill in questionaires on quality of life and sexuality
Exclusion criteria
- Other primairy malignancies exept carcinoma in situ of the cervix and basal cell carcinoma of the skin.
- Metastatic disease beyond para-aortic region (L1-L2)
- Vaginal extension of primary tumor.
- Pre-existent major vaginal morbidity.
- Previous pelvic or abdominal radiotherapy
- Combination of preoperative radiotherapy with surgery
- Patients receiving BrachyTherapy only.
- Patients receiing ExternalBeamRadioTherapy only.
- Patients receiving neoadjuvant chemotherapy
- Cotraindications to BrachyTherapy
- Active infection or severe medical condition endagering treatment delivery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41941.041.12 |