Functional Outcomes Following Anal Cancer Treatment

NCT ID: NCT01853059

Last Updated: 2013-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

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Conditions

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Anal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IMRT

Prospective longitudinal assessment of patients receiving intensity-modulated radiation therapy for anal cancer

No interventions assigned to this group

Conventional

Cross-sectional analysis of patients receiving conventional radiotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Christie NHS Foundation Trust

OTHER

Sponsor Role collaborator

Bowel Disease Research Foundation

UNKNOWN

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Adam Stearns

Specialist Registrar in Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

Christie Hospital

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Adam Stearns, MA DPhil BMBCh MRCS

Role: CONTACT

01603286286

References

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Provencher S, Oehler C, Lavertu S, Jolicoeur M, Fortin B, Donath D. Quality of life and tumor control after short split-course chemoradiation for anal canal carcinoma. Radiat Oncol. 2010 May 23;5:41. doi: 10.1186/1748-717X-5-41.

Reference Type BACKGROUND
PMID: 20492729 (View on PubMed)

Brown MW, Brooks JP, Albert PS, Poggi MM. An analysis of erectile function after intensity modulated radiation therapy for localized prostate carcinoma. Prostate Cancer Prostatic Dis. 2007;10(2):189-93. doi: 10.1038/sj.pcan.4500938. Epub 2006 Dec 26.

Reference Type BACKGROUND
PMID: 17189954 (View on PubMed)

Barraclough LH, Routledge JA, Farnell DJ, Burns MP, Swindell R, Livsey JE, Davidson SE. Prospective analysis of patient-reported late toxicity following pelvic radiotherapy for gynaecological cancer. Radiother Oncol. 2012 Jun;103(3):327-32. doi: 10.1016/j.radonc.2012.04.018. Epub 2012 May 23.

Reference Type BACKGROUND
PMID: 22633812 (View on PubMed)

Other Identifiers

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A092896

Identifier Type: -

Identifier Source: org_study_id

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