Sexual Function and Wellbeing in Females With Rectal Cancer

NCT01216189 | Completed Results DMC

• 1 other identifier: 2008/247-31/3
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Preoperative radiotherapy; Pelvic surgery; Sexual function; Wellbeing; Hormone levels

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Preoperative radiotherapy

Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.

Radiation: Preoperative radiotherapy

No preoperative radiotherapy

Women with rectal cancer treated with surgery alone (no RT).

Interventions

Preoperative radiotherapy RADIATION

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.

Preoperative radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Cancer Society: collaborator

Study Sites (5)

Linköping University Hospital

Linköping, Sweden

Location

Norrköping Hospital

Norrköping, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Ersta Hospital

Stockholm, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (3)

• Segelman J, Martling A, Machado M, Holm T, Bergmark K, Floter Radestad 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.

  PMID: 23953232 BACKGROUND

• Segelman J, Buchli C, Svanstrom Rojvall A, Matthiessen P, Arver S, Bottai M, Ahlberg M, Jasuja R, Floter-Radestad 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.10980. Epub 2018 Sep 12.

  PMID: 30277569 RESULT

• Svanstrom Rojvall A, Buchli C, Bottai M, Ahlberg M, Floter-Radestad 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 2019 Dec 3.

  PMID: 31792944 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples.

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Professor Anna Martling
• Organization: Karolinska Institutet

anna.martling@ki.se

+46851770000

Study Officials

• Anna Martling

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant Surgeon

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 7, 2010
• Study Start: June 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: April 9, 2021
• Results First Posted: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)