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Sexuo-physiological functioning after cervical cancer treatment


- candidate number22834
- NTR NumberNTR5453
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2015
- Secondary IDsNL54662.058.15 
- Public TitleSexuo-physiological functioning after cervical cancer treatment
- Scientific TitleAn observational controlled study on vaginal blood flow and sexual functioning after early stage cervical cancer treatment.
- ACRONYM
- hypothesisThe assumption is that frequency of sexual dysfunction and a disturbed vaginal blood flow response will be present, in ascending order, as follows: normal controls; women after nerve-sparing radical hysterectomy; women after nerve-sparing radical hysterectomy with post postoperative external beam radiation therapy and women after conventional RHL.
- Healt Condition(s) or Problem(s) studiedCervix cancer, Sexual function
- Inclusion criteriaAll eligible patients have been treated for FIGO stage IA2-IIA cervical cancer with (nerve-sparing) radical hysterectomy with or without post-operative radiation therapy; at least 1 year ago; have no signs of recurrent or metastatic cervical cancer ; are capable of understanding, reading and writing the Dutch language; are not pregnant; have performance status of WHO 1-2, Karnofsky >60; and are <75 years of age. Use of medication and hormonal substitutes is registered. The group of historical controls will be age-matched to the women treated for cervical cancer. They should also be capable of understanding, reading and writing the Dutch language; have performance status of WHO 1-2, Karnofsky >60; and are <75 years of age . Use of medication, hormonal substitutes and history of psychiatric illness is registered. Women are selected on pre-menopausal status because menopausal status may influence sexual functioning. Women that received RT are automatically post-menopausal.
- Exclusion criteriaWomen that receive intravaginal brachytherapy and/or concomitant chemotherapy; or are pregnant; are not included.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2005
- planned closingdate7-sep-2017
- Target number of participants120
- Interventions A prospective controlled observational study will be conducted. The effects of radical hysterectomy, nerve-sparing or conventional, with and without postoperative radiotherapy, on sexual functioning will be investigated by means of a questionnaires and vaginal photoplethysmografy. The results will be compared to historical controls (participants of the previous LUMC studies P05.095 and P10.066 are also included). The study will be conducted multicentre, in the departments of gynaecology of the Leiden University Medical Centre (LUMC) and Centre of Gynaecologic Oncology Amsterdam (CGOA), Location Academic Medical Centre. The photoplethysmography will be performed at the LUMC. Also, the study will be coordinated at the LUMC. The reason why this design has been chosen instead of a randomized trial is mainly based on the foreseen problem with quality control in surgery, when surgeons have been trained in the nerve sparing technique. From a former multicentre randomized trial we learned that using two different techniques by the same group of surgeons has lead to a contamination of two techniques in 48% of the cases. Furthermore, the reluctance of patients to be included in randomized trials might cause difficulties in the recruitment.
- Primary outcome Sexual response measurement To measure genital arousal, vaginal pulse amplitude (VPA) will be assessed by a vaginal photoplethysmograph. The photoplethysmograph is a menstrual tampon-sized device, containing an orange-red light source and a photocell. The light source illuminates the capillary bed of the vaginal wall and the phototransistor responds to the light backscattered by the vaginal wall and the blood circulating within it. When the signal is connected to an alternating current (AC) amplifier, vaginal pulse amplitude (VPA) is measured, which reflects the phasic changes in vaginal engorgement accompanying each heartbeat, with larger amplitudes reflecting higher levels of vaginal vasocongestion. VPA is a sensitive, specific, and reliable measure of vaginal vasocongestion and is used in earlier studies that observed diminished vaginal blood flow in women with neurological damage and in women after radical hysterectomy. VPA will be recorded continuously during the experimental session. The stimulus material will be identical to the previous studies. All women will be exposed to two erotic 5.5 min film excerpts (consisting of videos depicting cunnilingus and intercourse). The erotic films will be preceded by 5 min neutral film (during which a non-erotic documentary film excerpt will be shown). The erotic film excerpts are taken from so-called women-made, female-centred erotic videotapes. VPA is sampled at 20 Hz across baseline and subsequent trails. A two-pass algorithm for automatic artefact removal (© Molenkamp Technical Support Group University of Amsterdam) is used to analyze the VPA data. After artefact deletion peak-to-trough amplitude is calculated for each remaining pulse. For each 5-minute baseline recording, a mean baseline score per subject is calculated. Mean and maximum VPA for each subject within the entire session is identified (i.e. either within erotic stimulus one or two). Subjective sexual arousal will be assessed through 3 self-report ratings that will be collected after each neutral film and after each erotic stimulus. Participants will be asked to indicate on a seven-point Likert scale their feelings of sexual arousal. Extremes of the Likert scale will be 1 “not at all”, to 7 “very strong”.
- Secondary outcomeQuestionnaires Sexual functioning and physical complaints are assessed with the gynecologic Leiden Questionnaire (LQ). The questionnaire consists of 17-items and asked for senseless of the labia, lymphedema, sexual (dys)function, miction and bowel problem. Furthermore, sexual functioning is measured with the Female Sexual Function Index (FSFI). The questionnaire consists of 19-items, related to sexual desire, arousal, lubrication, orgasm, satisfaction and genital pain, that have to be answered on a five-point Likert scale. Furthermore, the Gynaecological symptom module questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC) EORTC QLQ-CX24 will be used. These questionnaires are especially designed and validated for the assessment of the quality of life and complaints of women after treatment for gynecological malignancies. Sexually related personal distress will be measured with the Dutch version of the 12 item Female Sexual Distress Scale (FSDS). A score of 15 or higher indicates sexual distress. The FSDS has been validated for the Dutch language and it has good psychometric properties. General health related quality of life is assessed by the Quality of Life core questionnaire of the EORTC (EORTC QLQ-C30). Furthermore, womens’ satisfaction with their sexual relationship was evaluated using the 28-item Golombok Rust Inventory of Sexual Satisfaction (GRISS). The questionnaire was also validated for the Dutch language and among gynaecological patients, and it has good psychometric properties. The presence of anxiety and depressive states will be assessed using the Hospital Anxiety and Depression Scale (HADS). Data obtained will be stored in a ProMISe database that has been especially developed for cervical cancer. Since this is a non-randomized trial a multivariate analysis will be used to correct for possible confounding factors (factors taken into account: FIGO-stage, time after treatment, age and parity) when the study groups are compared. Copyright holding authorities have approved the use of the questionnaires. Menopausal status Subjects are considered post-menopausal when they were older than 52 or did not menstruate in the past 12 months. In case subjects treated with RHL only menstruated regularly before the RHL, their ovary were not removed, LH and FSH-values are measured by taking a blood sample. A blood sample is also taken from healthy subjects between 40 and 52 years of age of which it is not clear whether they are pre-menopausal.
- TimepointsAt least one year after treatment for cervical cancer.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. C.D. de Kroon
- CONTACT for SCIENTIFIC QUERIESDr. M.M ter Kuile,
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
SOHA IKW, KWF Kankerbestrijding, Stichting Alpe d'HuZes
- Publications
- Brief summary
- Main changes (audit trail)6-dec-2015:

Inclusion NEW:
Eligible women are: treated for early stage cervical cancer (FIGO IA2 – IIA) at least 12 months before; treated with conventional radical hysterectomy with pelvic lymphadenectomy using the Okabayashi method (RHL-WO) at the AMC; younger than 52 years old; pre-menopausal; and have a performance status of WHO 1-2 and Karnofsky >60. Women are selected on menopausal status, because this can have influence on the vaginal perfusion response. In case eligible women of 40-52 years old that menstruated regularly before the RHL-WO, and report menopausal complaints, LH and FSH-values are measured by taking a blood sample so that their menopausal status could be established.

Exclusion criteria NEW:
Exclusion criteria are: signs of recurrent or metastatic cervical cancer after 1 year; treatment with external beam radiation therapy, intravaginal brachytherapy and/or concomitant chemotherapy; removed ovaries during surgery; not being able to understand, read and write the Dutch language; and being pregnant. Use of medication and hormonal substitutes is registered.

Interventions NEW:
An observational study will be conducted among women treated with a conventional (non-nerve sparing) radical hysterectomy for CC (P15.321). Among this group of women, the vaginal pulse amplitude (VPA) and subjective sexual arousal in response to sexual stimuli will be measured using vaginal photoplethysmography. The results obtained in the current study will be compared with the data of a group of women treated with a nerve-sparing RHL without external beam radiation (P05.095) or nerve-sparing RHL without external beam radiation (P10.066) and age-matched historical controls (from P05.095) by using a between (4 subject groups) X within (VPA) study design. The study will be conducted multicenter: The photoplethysmography will be performed at the LUMC. Also, the study is coordinated at the LUMC. Participants are recruited at the AMC.

Primary outcome NEW:
Vaginal pulse amplitude (VPA) in response to sexual stimuli. VPA will be measured by a vaginal photoplethysmograph. The photoplethysmograph is a menstrual tampon-sized device, containing an orange-red light source and a photocell. The light source illuminates the capillary bed of the vaginal wall and the phototransistor responds to the light backscattered by the vaginal wall and the blood circulating within it. When the signal is connected to an alternating current (AC) amplifier, vaginal pulse amplitude (VPA) is measured, which reflects the phasic changes in vaginal engorgement accompanying each heartbeat, with larger amplitudes reflecting higher levels of vaginal vasocongestion. VPA is a sensitive, specific, and reliable measure of vaginal vasocongestion and is used in earlier studies that observed diminished vaginal blood flow in women with neurological damage and in women after radical hysterectomy (see publication of Pieterse et al, 2008, protocol P05.095). VPA will be recorded continuously during the experimental session. The stimulus material will be identical to the previous studies. All women will be exposed to two erotic 5.5 min film excerpts (consisting of videos depicting cunnilingus and intercourse). The erotic films will be preceded by 5 min neutral film (during which a non-erotic documentary film excerpt will be shown). The erotic film excerpts are taken from so-called women-made, female-centred erotic videotapes. VPA is sampled at 20 Hz across baseline and subsequent trails. A two-pass algorithm for automatic artefact removal (© Molenkamp Technical Support Group University of Amsterdam) is used to analyse the VPA data. After artefact deletion peak-to-trough amplitude is calculated for each remaining pulse. For each 5-minute baseline recording, a mean baseline score per subject is calculated. Mean and maximum VPA for each subject within the entire session is identified (i.e. either within erotic stimulus one or two).

Secondary outcome NEW:
Subjective sexual arousal in response to sexual stimuli. Subjective sexual arousal will be assessed through 3 self-report ratings that will be collected after each neutral film and after each erotic stimulus. Participants will be asked to indicate on a seven-point Likert scale their feelings of sexual arousal. Extremes of the Likert scale will be 1 “not at all”, to 7 “very strong”. Furthermore, sexual complaints will be assessed using the Leiden Questionnaire (LQ), Gynaecological symptom module questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC) EORTC QLQ-CX24, and the Female Sexual Function Index (FSFI). General health related quality of life is assessed by the Quality of Life core questionnaire of the EORTC (EORTC QLQ-C30). The Female Sexual Distress Scale (FSDS) will measure sexually related personal distress. The womens’ satisfaction with their sexual relationship was evaluated using the Golombok Rust Inventory of Sexual Satisfaction (GRISS). The presence of anxiety and depressive states will be assessed using the Hospital Anxiety and Depression Scale (HADS). Data obtained will be registered and analyzed using SPSS.
- RECORD4-sep-2015 - 22-jun-2016


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