Functional Outcomes Following Anal Cancer Treatment

• Conditions: Anal Cancer

• Registration Number: NCT01853059
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Anal cancer is treated with chemoradiotherapy- combined chemotherapy and radiotherapy. This is very successful (75% long term survival). During the course of the radiotherapy, other organs in the pelvis may be damaged. This can lead to long-term problems with possible changes to the skin, bowels with diarrhoea and incontinence problems, bladder shrinkage and incontinence of urine, sexual problems including impotence and ejaculatory problems, or pain during sexual intercourse with vaginal dryness and shrinkage. Patients should be offered help with these side effects. At present, there is very little information on the effect treatment has on a patient's quality of life, making it difficult to judge if new treatment methods are better.

This project will measure quality of life from the patient's perspective after treatment for anal cancer. It will also gather preliminary data on quality of life after the introduction of a new technique for more precise 3D-targeting of radiotherapy beams at the cancer, called IMRT.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-10
• Last Update Submitted: 2013-05-13
• Study First Posted: 2013-05-14
• Last Update Posted: 2013-05-15
• Study Start: 2013-10
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Squamous cell or basaloid carcinoma of the anal canal

Exclusion Criteria

• adenocarcinoma, melanoma, lymphoma, sarcoma or other malignancy of anal canal
• Any synchronous or metanchronous pelvic malignancy of non-anal origin (eg. prostatic, genital tract)
• unable to complete questionnaire

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional quality of life after chemoradiotherapy for anal cancer	3 years	Quality of life measured using: General; * EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30; Disease specific; * EORTC QLQ-CR29; * Vaizey incontinence score; * MOS (Medical Outcomes Survey) sexual questionnaire

Secondary Outcome Measures

Name	Time	Method
Patient-reported treatment-related toxicity after chemoradiotherapy for anal cancer	3 years	Patient-reported treatment related toxicity measured with: * Common Terminology Criteria for Adverse Events (CTCAE version 3); * Pelvis questionnaire male \& female (LENT/SOMA); (LENT/SOMA: see Barraclough LH et al. Radiother Oncol; 103:327-32)

Trial Locations

Locations (2)

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

Christie Hospital; 🇬🇧 Manchester, United Kingdom