Sexual Function and Wellbeing in Females With Rectal Cancer

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 18 years and older
• Women only
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country.

About this study

Official title: Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer

Conditions

Rectal Cancer

Being tested

Preoperative radiotherapy

Keywords

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

Medical subject headings

Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Preoperative radiotherapyRadiation

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Baseline, the week before surgery and 1 year after surgery.

2. 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.

   Measured: Baseline, 1 year after surgery and 2 years after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted7 Oct 2010 (estimated)
2. Study startJun 2008
3. Primary completionDec 2013
4. Study completionDec 2015

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Rectal CancerStudies of the same condition, open and under way.
• More trials run by Karolinska InstitutetThe 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.