Sexual Function and Wellbeing in Females With Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216189
• Other study ID #: 2008/247-31/3
• Status: Completed
• Start date: June 2008
• Est. completion date: December 2015

Study information

• Verified date: April 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Preoperative radiotherapy (RT) and pelvic surgery is recommended to many patients with rectal cancer. For women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where androgen levels and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

Description:

Women with rectal cancer stage I to III planned for abdominal surgery was included in the study. Women treated with preoperative RT were assigned to the exposed group and women treated with surgery alone were assigned to the unexposed group. 142 participants were enrolled at five outpatient rectal cancer centres in Sweden between 2008 and 2013. Patient data, fasting venous blood samples and questionnaires regarding sexual function and well-being were collected at a baseline visit before start of oncologic treatment, 1 year after surgery and 2 years after surgery (only questionnaires). Women treated with preoperative RT for rectal cancer had an additional venous blood sample taken the day before surgery. Changes in serum levels of testosterone and sexual function during follow-up was assessed and compared between exposed and unexposed participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females diagnosed with rectal cancer stadium I-III, planned surgery with or without preoperative radiotherapy.

Exclusion Criteria:

• Rectal cancer stadium IV
• Previous radiotherapy to the pelvic region
• Inability to provide informed consent.
• Life expectancy less than 2 years.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Preoperative radiotherapy
Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.

Locations

Country	Name	City	State
Sweden	Linköping University Hospital	Linköping
Sweden	Norrköping Hospital	Norrköping
Sweden	Örebro University Hospital	Örebro
Sweden	Ersta Hospital	Stockholm
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Segelman J, Buchli C, Svanström Röjvall A, Matthiessen P, Arver S, Bottai M, Ahlberg M, Jasuja R, Flöter-Rådestad A, Martling A. Effect of radiotherapy for rectal cancer on ovarian androgen production. Br J Surg. 2019 Feb;106(3):267-275. doi: 10.1002/bjs. — View Citation

Segelman J, Martling A, Machado M, Holm T, Bergmark K, Flöter Rådestad A. Preoperative sexual function in women with rectal cancer. Eur J Surg Oncol. 2013 Oct;39(10):1079-86. doi: 10.1016/j.ejso.2013.07.091. Epub 2013 Aug 15. — View Citation

Svanström Röjvall A, Buchli C, Bottai M, Ahlberg M, Flöter-Rådestad A, Martling A, Segelman J. Effect of radiotherapy for rectal cancer on female sexual function: a prospective cohort study. Br J Surg. 2020 Apr;107(5):525-536. doi: 10.1002/bjs.11373. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.	Fasting venous blood samples were collected at baseline visit (prior to oncological treatment) and 1 year follow-up. Participants treated with preoperative radiotherapy (RT) had an additional blood sample taken the day before surgery. Serum testosterone levels (T) were measured with liquid chromatography-mass spectrometry using the LC-MS/MS Quattro Premier Xevo TQ MS (Waters Corporation, Milford, MA, USA). The total coefficients of variation (CVtot) were 7% at 2.8 nmol/L and 6% at 15 nmol/L.	Baseline, the week before surgery and 1 year after surgery.
Primary	Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.	Sexual function was assessed using the Female Sexual Function Index (FSFI). The FSFI questionnaire is a 19-item multiple-choice, self-assessment tool validated for use in the general population as well as for patients with cancer. It covers six domains of sexual function in women; desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). Items scores between 0 or 1 to 5, with lower scores indicating worse function. A total FSFI score can be calculated when all items are completed. Minimal total score is 4 points and maximal score is 95 points, with lower scores indicating worse function. A total FSFI score of less than 26.55 points was used to define overall sexual dysfunction.	Baseline, 1 year after surgery and 2 years after surgery.