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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

  1. First posted18 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionJul 2011
  4. Study completionDec 2011

Resources

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)
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 10228188
  • Bernardini 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 14634572
  • Boss 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 16140367
  • Butler-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 10951347
  • Butler-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 11839509
  • Juraskova 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 12673810
  • Plante 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 15350349
  • Plante 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 15936061
  • Sonoda 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 15581959
  • Wenzel 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 11921330
  • Weijmar 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.

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.

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