Dietary counselling to increase soluble fibre in patients with gynaecological cancers undergoing pelvic radiotherapy: a feasibility study

Not Applicable

• Conditions: Gynaecology Cancer; Diarrhoea secondary to pelvic radiotherapy; Cancer - Ovarian and primary peritoneal; Cancer - Womb (Uterine or endometrial cancer); Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cancer - Cervical (cervix)

• Registration Number: ACTRN12621000525886
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1.Female diagnosed with gynaecological cancer attending the Royal Brisbane and Women’s Hospital (RBWH) for definitive or adjuvant pelvic radiotherapy- with curative intent (may or may not be undergoing sequential or concurrent chemotherapy).
2.Aged 18 years or older
3.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
4.Able to provide signed, written informed consent

Exclusion Criteria

1.Patients undergoing palliative-intent treatment
2.Patients undergoing extended field radiation treatment or has completed previous pelvic radiotherapy
3.Involvement in any other clinical trials and/or on immunotherapy
4.Other GI disease - i.e. Crohn’s disease, ulcerative colitis, bowel inflammation, irritable bowel syndrome (IBS), diverticulitis, high risk of small bowel obstruction
5.Cognitive function impairment
6.Inability to speak/ understand English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence (70%) as per screen fail rates determined by audit of study database.<br>[Upon commencement of intervention and during (i.e. weekly throughout radiation treatment), with the primary endpoint being at the end of the last week of radiation treatment,];Adherence (70%) as per proportion of participants adhering (defined as achieving 80% of goal) to dietary intervention assessed using 3-day food diary (designed specifically for this study). <br>[Upon commencement of intervention and during (i.e. weekly throughout radiation treatment), with the primary endpoint being at the end of the last week of radiation treatment,]