Clinical Trial: Cervical or Endomterial Cancer and Sexual Health Study, Phase 1 & 2

This study is not yet open for patient recruitment.
Verified by University of British Columbia August 2005

Sponsors and Collaborators: University of British Columbia
Canadian Institutes of Health Research
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00134316

Purpose

Phase 1:

Aim #1. To investigate the efficacy of Viagra (50mg and 100mg) on sexual arousal in a randomized, double-blind, placebo-controlled, 3-way cross-over design.

Hypothesis 1 (H1): Acute administration of 50mg and 100mg Viagra during visual sexual stimulation will result in (compared to placebo) significant improvement in:

  1. subjective sexual arousal;
  2. self-reported genital sensitivity;
  3. psychophysiological sexual arousal, as assessed by a vaginal probe.

Aim #2. To determine which dose of Viagra (50mg or 100mg) exhibits the greatest improvement on subjective and psychophysiological measures of sexual arousal, and the least number of side effects. This dose will then be used in Phase 2.

Phase 2:

Aim #1. To investigate the efficacy of the psychoeducational intervention (PED), both alone and in combination with Viagra, on sexual arousal.

H1: Compared to a control group (+ placebo) and to baseline, PED (+ placebo) will result in significant improvement in:

  1. self-reported subjective sexual arousal;
  2. self-reported genital sensitivity;
  3. psychophysiological sexual arousal.

H2: Compared to the PED + placebo condition, the PED + Viagra condition will result in significant improvement in:

  1. self-reported subjective sexual arousal;
  2. self-reported genital sensitivity;
  3. psychophysiological sexual arousal.

Aim #2. To investigate the efficacy of the PED, both alone and in combination with Viagra, on self-reported orgasm, sexual desire, distress, and relationship satisfaction.

H3: Compared to a control group (+ placebo) and to baseline, PED (+ placebo) will result in significant improvement in self-reported orgasmic experience, sexual desire, sexual distress, and relationship satisfaction.

H4: Compared to the PED + placebo condition, the PED + Viagra condition will result in significant improvement in self-reported orgasmic experience, sexual desire, sexual distress, and relationship satisfaction.

Aim #3. To investigate the efficacy of the PED, both alone and in combination with Viagra, on depressive symptoms and quality of life.

H5: Compared to a control group (+ placebo) and to baseline, PED (+ placebo) will result in significant improvement in self-reported depressive symptoms and quality of life.

H6: Compared to the PED + placebo condition, the PED + Viagra condition will result in significant improvement in self-reported depressive symptoms and quality of life.

Condition Intervention
Sexual Dysfunctions, Psychological
 Drug: sildenafil (Viagra) or placebo
 Behavior: psychoeducational intervention

MedlinePlus related topics:  Female Sexual Dysfunction

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Phase 1: upon completion of data analysis the lowest effective dose of sildenafil (Viagra)will be determined for use in Phase 2.; Phase 2: Upon completion of data analysis establishment of the efficacy of a psychoeducational intervention (PED)in a sample of cervical or endometrial cancer survivors with sexual Arousal Disorder will be determined.; Data analysis will also show if there is added benefit of combining PED with sildenafil.
Expected Total Enrollment:  66

Study start: August 2005;  Expected completion: February 2009
Last follow-up: August 2008;  Data entry closure: December 2008

Whereas relatively more research and therapy options exist for physical treatments of sexual dysfunction in women with a history of cervical cancer (e.g. hormone replacement, surgery; Denton & Maher, 2003), there is some evidence that psychological interventions have positive effects on sexuality. For example, a brief psychoeducational program for women with early-stage cervical cancer resulted in significant improvements in the frequency of coital activity (Capone et al., 1980), and enhanced compliance with sexual rehabilitation, reduced fear about intercourse and improved sexual knowledge compared to a control condition (Robinson et al., 1999). Unfortunately, neither study targeted nor assessed sexual arousal or genital sensations – symptoms documented to be most problematic and distressing in this group of women. There is also evidence that providing a venue for women to receive education and discuss sexual concerns following cervical cancer is therapeutic as it might encourage women to be more aware of their sexual rehabilitation and capacity for change, thus evoking a more active coping style (Leenhouts et al., 2002). Taken together, these studies suggest that psychoeducational interventions are feasible and significantly improve general domains of sexual function, such as sexual frequency and knowledge, in cervical cancer survivors.

Although directly targeting psychological constructs such as thoughts, affect, and behaviour, psychological treatments can also evoke physiological change. In cervical cancer-related sexual dysfunction where the psychological and physical contributors of impairment are difficult to tease apart, a psychoeducational intervention that addresses both etiological domains is essential. We have recently developed a 3-session psychoeducational intervention designed to address both the physical and psychological consequences of cervical cancer on sexual arousal (treatment manual provided in Appendix 1b). The sexual arousal concerns reported by this group of women fit the criteria for Female Sexual Arousal Disorder (FSAD), defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revised (DSM-IV-TR) as “persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement” where “the disturbance causes marked distress or interpersonal difficulty” (American Psychiatric Association, 2000). A proportion of these women also experience new onset difficulties becoming subjectively sexually aroused, likely as a direct result of the genital arousal difficulties, but also due to the impact of cancer and hysterectomy on psychological function. Despite the wide prevalence of such subjective arousal concerns, this is not a diagnostic category in the DSM-IV-TR. However, the International Consultation on Sexual Dysfunctions, in collaboration with the World Health Organization, has suggested that “Subjective Sexual Arousal Disorder” be recognized as a valid concern (Basson et al., 2003). Evidence-based treatments for FSAD related to genital or subjective arousal difficulties do not exist, and persisting distress due to untreated sexual dysfunction can compromise mental and physical health. The contents of our psychoeducational intervention were based on: (1) empirically supported techniques in other areas of female sexual dysfunction (e.g., sensate focus, challenging of maladaptive cognitions and sexual myths), (2) discussions with gynecological oncologists at the University of Washington who are usually the first-line recipients of such sexual complaints, and (3) pilot interviews conducted with 18 cervical and endometrial cancer survivors to date. The intervention focuses primarily on sexual arousal, both genital and subjective, and secondarily on the interaction between cervical cancer and radical hysterectomy with relationship satisfaction, body image, and beliefs about health.

Eligibility

Ages Eligible for Study:  19 Years   -   65 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  1. diagnosis of cervical or endometrial cancer, in remission for at least 1 year;
  2. treatment by radical hysterectomy 1-5 years earlier;
  3. diagnosis of female sexual arousal disorder (FSAD) according to DSM-IV-TR criteria with new onset after the hysterectomy;
  4. currently involved in a relationship.

Exclusion Criteria:

  1. treatment by simple hysterectomy;
  2. treatment by either radiation or chemotherapy alone;
  3. current diagnosis of primary hypoactive sexual desire disorder – or in other words, if complaints of sexual desire are present, they must be less distressing than the sexual arousal complaints;
  4. unstable psychopathology and Beck Depression Inventory Scores greater than 19;
  5. lack of sexual experience;
  6. current use of antidepressants or other medication with known sexual side-effects;
  7. those with a physical condition that would impede participation in the psychophysiological assessment;
  8. cardiac problems;
  9. use of nitrates or any medication with cytochrome P-450 3A4 inhibitory activity.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00134316

Lori A Brotto, PhD      604 875 4111  Ext. 68988    lori.brotto@vch.ca

Canada, British Columbia
      Vancouver Hospital, Vancouver,  British Columbia,  V5Z 1M9,  Canada
Lori A Brotto, PhD  604 875 4111  Ext. 68898    lori.brotto@vch.ca 

Study chairs or principal investigators

Rosemary Basson, FCRP (UK),  Principal Investigator,  University of British Columbia   

More Information

Publications

Butler L, Banfield V, Sveinson T, Allen K. Conceptualizing sexual health in cancer care. West J Nurs Res. 1998 Dec;20(6):683-99; discussion 700-5.

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.

Grumann M, Robertson R, Hacker NF, Sommer G. Sexual functioning in patients following radical hysterectomy for stage IB cancer of the cervix. Int J Gynecol Cancer. 2001 Sep-Oct;11(5):372-80.

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.

Kylstra WA, Leenhouts GH, Everaerd W, Panneman MJ, Hahn DE, Weijmar Schultz WC, Van De Wiel HB, Heintz AP. Sexual outcomes following treatment for early stage gynecological cancer: a prospective multicenter study. Int J Gynecol Cancer. 1999 Sep;9(5):387-395.

Robinson JW, Faris PD, Scott CB. Psychoeducational group increases vaginal dilation for younger women and reduces sexual fears for women of all ages with gynecological carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):497-506.

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.

Andersen BL, Woods XA, Copeland LJ. Sexual self-schema and sexual morbidity among gynecologic cancer survivors. J Consult Clin Psychol. 1997 Apr;65(2):221-9.

Anderson BJ, Wolf FM. Chronic physical illness and sexual behavior: psychological issues. J Consult Clin Psychol. 1986 Apr;54(2):168-75. No abstract available.

Butler L, Banfield V, Sveinson T, Allen K. Conceptualizing sexual health in cancer care. West J Nurs Res. 1998 Dec;20(6):683-99; discussion 700-5.

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. Erratum in: Cancer 2000 Nov 15;89(10):2144.

Capone MA, Good RS, Westie KS, Jacobson AF. Psychosocial rehabilitation of gynecologic oncology patients. Arch Phys Med Rehabil. 1980 Mar;61(3):128-32.

Leenhouts GH, Kylstra WA, Everaerd W, Hahn DE, Schultz WC, van de Wiel HB, Heintz AP. Sexual outcomes following treatment for early-stage gynecological cancer: a prospective and cross-sectional multi-center study. J Psychosom Obstet Gynaecol. 2002 Jun;23(2):123-32.

Basson R, Brotto LA. Sexual psychophysiology and effects of sildenafil citrate in oestrogenised women with acquired genital arousal disorder and impaired orgasm: a randomised controlled trial. BJOG. 2003 Nov;110(11):1014-24.

Study ID Numbers:  UBC-SH-CECSH.P1&2-20R91396; CIHR-PG#20R91396
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00134316
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30



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