Vaginal Effects after Radiation Therapy in Anal Cancer Study

Interventions: All participants will undergo standard chemoradiation over 6 weeks. They will receive education by verbal counselling and written information regarding the side effects of pelvic radiotherapy and vaginal dilator use. This will be a one-on-one session taking approximately 30 minutes, performed by qualified nursing staff. This will be conducted in the last week of chemoradiation (i.e. week 6) and repeated at the 3-month review.
Participants will be followed up at 4 weeks; and 3, 6, 9, 12, 18, 24 and 36 months after treatment. At each review session, compliance with vaginal dilator use, vaginal examinations for toxicity scoring, and quality of life questionnaires will be completed and documented.
Standard education will comprise of verbal and written information regarding the side effects of pelvic radiation. Permission for sexual intercourse is given to participants and frequency is documented.
Standard recommendation for vaginal dilator use: initiate vaginal dilator insertion within 6 weeks of completing chemoradiation, insert 3 times per week for 5 minutes duration, as tolerated.
Radiotherapy Schedule
Standard chemoradiation to 54 Gy in 30 fractions, 5 fractions per week using a three phase 3D-conformal technique.
From 2011, all participants except staged T1N0M0 are treated with a two-phase IMRT technique using simultaneous integrated boost.
Chemotherapy Schedule
Standard concurrent chemotherapy consists of infusional 5FU in week 1 and 5, with MMC on day 1. Some participants will receive PVI 5FU for 96 hours each week.
Vaginal Dilator
Vaginal dilators are smooth rigid cylinder-shaped pieces of plastic made of Delrin (Registered Trademark) acetal homopolymer.
Vaginal Dilator Therapy
Vaginal dilato
Primary outcome(s): Overall compliance: Adherence to the recommended dilator regimen (Yes or No) as defined by satisfying any three of the following four criteria:
Commence dilator use within 6 weeks of completing chemoradiation
A combined average frequency of dilator use and/or sexual intercourse of at least 3 times per week
An average insertion duration of at least 5 minutes
A duration of use of at least 12 months[Information regarding the following individual components of dilator use and sexual intercourse will be collected at baseline and at each of the follow-up reviews in order to determine the primary endpoint of overall compliance:
Time between completion of chemoradiation to initiation of dilator use (days/weeks) (<4 weeks, 4-6 weeks, 6-12 weeks, >12 weeks)
Average frequency of use (times per week) (<2, 2-3, >3 times per week)
Average duration of insertion (minutes) (<5, 5-10, >10 minutes)
Duration of dilator use (weeks/months/years) (6 weeks, 3, 6, 9, 12 months, 1-3 years, indefinitely)
Average frequency of sexual intercourse (times per week)]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy