Cervical CancerNCT00278798
TRAIL-CC: Trachelectomy, Radical Hysterectomy, and Intimate Life After Cervical Cancer Study
An observational study of Cervical Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
The objective of this study is to compare radical hysterectomy with trachelectomy on outcomes related to intimacy, sexual health, and mood immediately before, 1 month after, and 6 months after surgery. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Cervical Cancer
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with cervical or endometrial cancer
Who may be able to join
- Women who have a diagnosis of cervical cancer
- Women who are scheduled for either a radical hysterectomy or radical trachelectomy at the British Columbia Cancer Agency - Vancouver Cancer Centre
- Proficient in English
Who cannot join
- No woman who meets the inclusion criteria will be excluded from participating.
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 1M9
About this study
The objective of this study is to compare radical hysterectomy with trachelectomy on outcomes related to intimacy, sexual health, and mood immediately before, 1 month after, and 6 months after surgery.
Read the detailed description
Improvements in our treatment of these cancers has resulted in an increased focus on quality of life issues. Sexual health is one such important aspect of quality of life that is often disrupted in cervical cancer survivors. However, currently there are no established treatments for such sexual problems, often leaving women and their partners with long-term difficulties that interfere in other aspects of their relationship and lives.
Treatment of cervical cancer involves hysterectomy (i.e. removal of the uterus), and commonly bilateral salpingo-oophorectomy (BSO; i.e. bilateral removal of the ovaries and fallopian tubes). Hysterectomy results in direct physical consequences to sexual function which have been attributed to probable autonomic nerve damage (Butler-Manuel et al., 2000; 2002; Weijmar Schultz et al., 1991). Depending on the extent of disease, hysterectomy may be either simple (i.e. surgical removal of the uterus without excision of adjoining tissue) or radical (i.e. surgical removal of the uterus, the parametria and uterosacral ligaments, the upper portion of the vagina, and the pelvic lymph nodes).
In the last two decades, a new procedure known as trachelectomy, has surfaced to treat early stages of cervical cancer. Unlike radical hysterectomy, the trachelectomy procedure aims to preserve the fertility in young women who wish to have children post cervical cancer and treatment (Plante et al., 2004; 2005). This preservation of fertility in trachelectomy is a result of leaving the patient's uterus intact while removing the cervix, parametrium and upper one third of the vagina. With the uterus intact, the patients are capable of conceiving multiple births post-procedure (Bernardini et al., 2003, Plante et al., 2004; 2005), an option that was not present in the past for women after radical hysterectomy.
The few dozen studies done looking at the outcomes of trachelectomy have mainly focused on medical outcomes such as fertility and cancer cure and recurrence. The findings show there is a 70-72% success rate in women who try to conceive post-trachelectomy (Boss et al., 2005, Plante et al., 2005). If a patient is eligible for a trachelectomy procedure, according to the criteria (Sonoda et al., 2004), recurrence-free survival is excellent at 95% (Plante et al., 2004).
With such improvements in the identification and cure of cervical cancer and the use of fertility-sparing techniques, there has been an increase in the number of young patients in remission, raising a number of quality of life issues. Sexual health is recognized as an integral aspect of quality of life during survivorship and is increasingly receiving research and clinical attention (Juraskova et al., 2003; Wenzel et al., 2002). In the studies done on trachelectomy we find that there are a handful of women who, prior to the operation, wish to conceive a child, but post-operation lose this desire and do not try to conceive (Boss et al., 2005, Plante et al., 2005), but no further studies have been done in this area as to the reasons why. Although the studies have been very beneficial for medical information none of the studies examining the efficacy of trachelectomy have studied the impact on sexual health or quality of life. On the other hand, research on the effects of radical hysterectomy in women with cervical cancer finds approximately half of women experience negative sexual side-effects such as significantly more lubrication difficulties, reduced vaginal length and elasticity, and marked distress (Bergmark et al., 1999). Also distressing to 36% of the women in this group is the absence of genital swelling in more than half of their sexual encounters, despite no changes in sexual frequency or orgasmic experience (Bergmark et al., 1999). When a vaginal photoplethysmograph was used to document changes in genital blood flow (an indirect measure of sexual arousal), women with radical hysterectomy had more impairment in blood flow responses than either a control group or a simple hysterectomy group, suggesting involvement of autonomic nerves (Maas et al., 2002).
Given that women, together with their partners and oncologists, may find themselves in a position of selecting one procedure over another, it seems important to better understand the relative effects of these procedures on intimate life and sexual health. The objective of this study, therefore, is to compare radical hysterectomy with trachelectomy in the effects on intimacy, sexual health, and mood immediately before, 1 month after, and 6 months after surgery.
This study will help to identify patterns and outcomes on these aspects of quality of life in hopes of better informing women of the potential outcomes of their procedures. Cervical cancer and treatment are life-altering events; therefore it is desirable to identify and hopefully reduce any negative psychological and physical sequelae of treatment. We want to ensure that problems related to post-cervical cancer are diminished so that the survivor's quality of life can be maintained at an acceptable level, allowing the patients to continue living a fulfilling life, uninhibited by sexual and emotional distress.
- Conditions
- Cervical Cancer
- Keywords
- tracehelectomy, radical hysterectomy
- Medical subject headings
- Uterine Cervical Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori A Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278798
- Sponsor's protocol ID
- C05-0591
- Status last verified
- May 2017
- First submitted
- 16 Jan 2006
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bergmark K, Avall-Lundqvist E, Dickman PW, Henningsohn L, Steineck G. Vaginal changes and sexuality in women with a history of cervical cancer. N Engl J Med. 1999 May 6;340(18):1383-9. doi: 10.1056/NEJM199905063401802.
PubMed 10228188Bernardini M, Barrett J, Seaward G, Covens A. Pregnancy outcomes in patients after radical trachelectomy. Am J Obstet Gynecol. 2003 Nov;189(5):1378-82. doi: 10.1067/s0002-9378(03)00776-2.
PubMed 14634572Boss EA, van Golde RJ, Beerendonk CC, Massuger LF. Pregnancy after radical trachelectomy: a real option? Gynecol Oncol. 2005 Dec;99(3 Suppl 1):S152-6. doi: 10.1016/j.ygyno.2005.07.071. Epub 2005 Sep 2.
PubMed 16140367Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000 Aug 15;89(4):834-41. doi: 10.1002/1097-0142(20000815)89:43.0.co;2-7.
PubMed 10951347Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical and simple hysterectomy: a quantitative study of nerve types in the uterine supporting ligaments. J Soc Gynecol Investig. 2002 Jan-Feb;9(1):47-56. doi: 10.1016/s1071-5576(01)00145-9.
PubMed 11839509Juraskova I, Butow P, Robertson R, Sharpe L, McLeod C, Hacker N. Post-treatment sexual adjustment following cervical and endometrial cancer: a qualitative insight. Psychooncology. 2003 Apr-May;12(3):267-79. doi: 10.1002/pon.639.
PubMed 12673810Plante M, Renaud MC, Francois H, Roy M. Vaginal radical trachelectomy: an oncologically safe fertility-preserving surgery. An updated series of 72 cases and review of the literature. Gynecol Oncol. 2004 Sep;94(3):614-23. doi: 10.1016/j.ygyno.2004.05.032.
PubMed 15350349Plante M, Renaud MC, Hoskins IA, Roy M. Vaginal radical trachelectomy: a valuable fertility-preserving option in the management of early-stage cervical cancer. A series of 50 pregnancies and review of the literature. Gynecol Oncol. 2005 Jul;98(1):3-10. doi: 10.1016/j.ygyno.2005.04.014.
PubMed 15936061Sonoda Y, Abu-Rustum NR, Gemignani ML, Chi DS, Brown CL, Poynor EA, Barakat RR. A fertility-sparing alternative to radical hysterectomy: how many patients may be eligible? Gynecol Oncol. 2004 Dec;95(3):534-8. doi: 10.1016/j.ygyno.2004.07.060.
PubMed 15581959Wenzel LB, Donnelly JP, Fowler JM, Habbal R, Taylor TH, Aziz N, Cella D. Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study. Psychooncology. 2002 Mar-Apr;11(2):142-53. doi: 10.1002/pon.567.
PubMed 11921330Weijmar Schultz, W. C. M., van de Wiel, H. B. M. & Bouma, J. (1991) Psychosexual functioning after treatment for cancer of the cervix: A comparative and longitudinal study. Int J Gynecol Cancer, 1, 37-46.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAIL-CC: Trachelectomy, Radical Hysterectomy, and Intimate Life After Cervical Cancer Study
- ClinicalTrials.gov ID
- NCT00278798
- Acronym / sponsor ID
- C05-0591
- Conditions
- Cervical Cancer
- Keywords
- tracehelectomy, radical hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare radical hysterectomy with trachelectomy on outcomes related to intimacy, sexual health, and mood immediately before, 1 month after, and 6 months after surgery.
Detailed description
Improvements in our treatment of these cancers has resulted in an increased focus on quality of life issues. Sexual health is one such important aspect of quality of life that is often disrupted in cervical cancer survivors. However, currently there are no established treatments for such sexual problems, often leaving women and their partners with long-term difficulties that interfere in other aspects of their relationship and lives.
Treatment of cervical cancer involves hysterectomy (i.e. removal of the uterus), and commonly bilateral salpingo-oophorectomy (BSO; i.e. bilateral removal of the ovaries and fallopian tubes). Hysterectomy results in direct physical consequences to sexual function which have been attributed to probable autonomic nerve damage (Butler-Manuel et al., 2000; 2002; Weijmar Schultz et al., 1991). Depending on the extent of disease, hysterectomy may be either simple (i.e. surgical removal of the uterus without excision of adjoining tissue) or radical (i.e. surgical removal of the uterus, the parametria and uterosacral ligaments, the upper portion of the vagina, and the pelvic lymph nodes).
In the last two decades, a new procedure known as trachelectomy, has surfaced to treat early stages of cervical cancer. Unlike radical hysterectomy, the trachelectomy procedure aims to preserve the fertility in young women who wish to have children post cervical cancer and treatment (Plante et al., 2004; 2005). This preservation of fertility in trachelectomy is a result of leaving the patient's uterus intact while removing the cervix, parametrium and upper one third of the vagina. With the uterus intact, the patients are capable of conceiving multiple births post-procedure (Bernardini et al., 2003, Plante et al., 2004; 2005), an option that was not present in the past for women after radical hysterectomy.
The few dozen studies done looking at the outcomes of trachelectomy have mainly focused on medical outcomes such as fertility and cancer cure and recurrence. The findings show there is a 70-72% success rate in women who try to conceive post-trachelectomy (Boss et al., 2005, Plante et al., 2005). If a patient is eligible for a trachelectomy procedure, according to the criteria (Sonoda et al., 2004), recurrence-free survival is excellent at 95% (Plante et al., 2004).
With such improvements in the identification and cure of cervical cancer and the use of fertility-sparing techniques, there has been an increase in the number of young patients in remission, raising a number of quality of life issues. Sexual health is recognized as an integral aspect of quality of life during survivorship and is increasingly receiving research and clinical attention (Juraskova et al., 2003; Wenzel et al., 2002). In the studies done on trachelectomy we find that there are a handful of women who, prior to the operation, wish to conceive a child, but post-operation lose this desire and do not try to conceive (Boss et al., 2005, Plante et al., 2005), but no further studies have been done in this area as to the reasons why. Although the studies have been very beneficial for medical information none of the studies examining the efficacy of trachelectomy have studied the impact on sexual health or quality of life. On the other hand, research on the effects of radical hysterectomy in women with cervical cancer finds approximately half of women experience negative sexual side-effects such as significantly more lubrication difficulties, reduced vaginal length and elasticity, and marked distress (Bergmark et al., 1999). Also distressing to 36% of the women in this group is the absence of genital swelling in more than half of their sexual encounters, despite no changes in sexual frequency or orgasmic experience (Bergmark et al., 1999). When a vaginal photoplethysmograph was used to document changes in genital blood flow (an indirect measure of sexual arousal), women with radical hysterectomy had more impairment in blood flow responses than either a control group or a simple hysterectomy group, suggesting involvement of autonomic nerves (Maas et al., 2002).
Given that women, together with their partners and oncologists, may find themselves in a position of selecting one procedure over another, it seems important to better understand the relative effects of these procedures on intimate life and sexual health. The objective of this study, therefore, is to compare radical hysterectomy with trachelectomy in the effects on intimacy, sexual health, and mood immediately before, 1 month after, and 6 months after surgery.
This study will help to identify patterns and outcomes on these aspects of quality of life in hopes of better informing women of the potential outcomes of their procedures. Cervical cancer and treatment are life-altering events; therefore it is desirable to identify and hopefully reduce any negative psychological and physical sequelae of treatment. We want to ensure that problems related to post-cervical cancer are diminished so that the survivor's quality of life can be maintained at an acceptable level, allowing the patients to continue living a fulfilling life, uninhibited by sexual and emotional distress.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with cervical or endometrial cancer
Key inclusion criteria (3 listed)
- Women who have a diagnosis of cervical cancer
- Women who are scheduled for either a radical hysterectomy or radical trachelectomy at the British Columbia Cancer Agency - Vancouver Cancer Centre
- Proficient in English
Key exclusion criteria (1 listed)
- No woman who meets the inclusion criteria will be excluded from participating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Background: PubMed 10228188Bergmark K, Avall-Lundqvist E, Dickman PW, Henningsohn L, Steineck G. Vaginal changes and sexuality in women with a history of cervical cancer. N Engl J Med. 1999 May 6;340(18):1383-9. doi: 10.1056/NEJM199905063401802.
- Background: PubMed 14634572Bernardini M, Barrett J, Seaward G, Covens A. Pregnancy outcomes in patients after radical trachelectomy. Am J Obstet Gynecol. 2003 Nov;189(5):1378-82. doi: 10.1067/s0002-9378(03)00776-2.
- Background: PubMed 16140367Boss EA, van Golde RJ, Beerendonk CC, Massuger LF. Pregnancy after radical trachelectomy: a real option? Gynecol Oncol. 2005 Dec;99(3 Suppl 1):S152-6. doi: 10.1016/j.ygyno.2005.07.071. Epub 2005 Sep 2.
- Background: PubMed 10951347Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000 Aug 15;89(4):834-41. doi: 10.1002/1097-0142(20000815)89:43.0.co;2-7.
- Background: PubMed 11839509Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical and simple hysterectomy: a quantitative study of nerve types in the uterine supporting ligaments. J Soc Gynecol Investig. 2002 Jan-Feb;9(1):47-56. doi: 10.1016/s1071-5576(01)00145-9.
- Background: PubMed 12673810Juraskova I, Butow P, Robertson R, Sharpe L, McLeod C, Hacker N. Post-treatment sexual adjustment following cervical and endometrial cancer: a qualitative insight. Psychooncology. 2003 Apr-May;12(3):267-79. doi: 10.1002/pon.639.
- Background: PubMed 15350349Plante M, Renaud MC, Francois H, Roy M. Vaginal radical trachelectomy: an oncologically safe fertility-preserving surgery. An updated series of 72 cases and review of the literature. Gynecol Oncol. 2004 Sep;94(3):614-23. doi: 10.1016/j.ygyno.2004.05.032.
- Background: PubMed 15936061Plante M, Renaud MC, Hoskins IA, Roy M. Vaginal radical trachelectomy: a valuable fertility-preserving option in the management of early-stage cervical cancer. A series of 50 pregnancies and review of the literature. Gynecol Oncol. 2005 Jul;98(1):3-10. doi: 10.1016/j.ygyno.2005.04.014.
- Background: PubMed 15581959Sonoda Y, Abu-Rustum NR, Gemignani ML, Chi DS, Brown CL, Poynor EA, Barakat RR. A fertility-sparing alternative to radical hysterectomy: how many patients may be eligible? Gynecol Oncol. 2004 Dec;95(3):534-8. doi: 10.1016/j.ygyno.2004.07.060.
- Background: PubMed 11921330Wenzel LB, Donnelly JP, Fowler JM, Habbal R, Taylor TH, Aziz N, Cella D. Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study. Psychooncology. 2002 Mar-Apr;11(2):142-53. doi: 10.1002/pon.567.
- BackgroundWeijmar Schultz, W. C. M., van de Wiel, H. B. M. & Bouma, J. (1991) Psychosexual functioning after treatment for cancer of the cervix: A comparative and longitudinal study. Int J Gynecol Cancer, 1, 37-46.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Brotto, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00278798, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.