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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000525886
Enrollment
40
Registered
2021-05-05
Start date
2021-05-11
Completion date
2022-04-05
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial aims to determine the feasibility, safety, and efficacy of dietary counselling to increase soluble fibre for reducing pelvic radiotherapy-related gastrointestinal symptoms in patients with gynaecological cancer. Who is it for? You may be eligible for this study if you are 18 or above, have been diagnosed with a gynaecological cancer, and are attending the Royal Brisbane and Women’s Hospital (RBWH) for pelvic radiotherapy with curative intent. Study details All participants will be provided with weekly, 45-minute telehealth appointments with a dietitian to discuss strategies for increasing dietary fibre and general nutritional advice, for the duration of radiation treatment. During this period, participants will be asked to maintain a weekly three-day food and symptom diary. Participants will also be provided with a number of questionnaires to complete upon commencement of radiation treatment and at the end of treatment. It is hoped that this study may demonstrate that dietary counselling to increase soluble fibre is feasible, safe, and efficacious in managing radiotherapy-related gastrointestinal symptoms in women with gynaecological cancers.

Interventions

There are some potential benefits recently demonstrated with a high fibre intervention in improving gastrointestinal symptoms in patients with gynaecological cancers secondary to pelvic radiation treatment. Before further investigation into fibre as a therapeutic agent is undertaken, it must first be determined if increasing fibre intake will adversely affect radiation treatment delivery, as it is anticipated there will be an increase in gas production, which may affect bowel positioning. Hence,

There are some potential benefits recently demonstrated with a high fibre intervention in improving gastrointestinal symptoms in patients with gynaecological cancers secondary to pelvic radiation treatment. Before further investigation into fibre as a therapeutic agent is undertaken, it must first be determined if increasing fibre intake will adversely affect radiation treatment delivery, as it is anticipated there will be an increase in gas production, which may affect bowel positioning. Hence, this study will look at whether an increased dietary fibre intervention is feasible in this population group without significantly affecting treatment fields and administration. Nutrition counselling and education by the research dietitian will be provided weekly via 30-45 minute one-on-one telehealth appointments throughout their radiation treatment to ensure the target fibre intake is achieved/maintained during this period. The initial session will involve: - An assessment of their nutritional status (weight and PG-SGA) - 24-diet recall to assess their total current dietary fibre intake and soluble fibre intake at baseline. - Education of dietary fibre – overview of types of fibre (soluble and insoluble) and their function; common food sources; use of educational resources of which includes a ready reckoner, sourced from the Fibre Categories Database (Fuller et al., 2018), listing common foods and their fibre composition that participants can refer to when recording their soluble fibre intake in the food diaries provided. - Develop (in liaison with the dietitian) a personalized meal plan/suggestions and strategies to gradually increase or modify dietary fibre intake, depending on baseline intake of dietary fibre (to avoid intolerance issues) - Demonstration of how to accurately record intake using a 3-day food diary (template designed specifically for this study and provided to participants) - Provision of contact details of the treating dietitian should they require additional support. Participants will be made aware that they are permitted to access dietetic services as much as required. Total time with dietitian will be recorded and documented for each participant. Weekly review sessions will include: - Assessment of their adherence via completion of the 3-day diet diaries - Weekly weights - Nutrition counselling and education to ensure the target fibre intake is reached and maintained each week throughout treatment - Nutritional counselling to ensure maintenance of nutritional status and to manage any other nutrition-impact symptoms from treatment. The intervention will be individualised to account for variation in baseline dietary soluble fibre intake between individuals and to mitigate excess gas being produced as a result of significantly increasing fibre consumption in a short period of time. Once the baseline fibre intake is assessed for each individual upon commencement of the intervention, the study dietitian will assist in developing a meal plan in collaboration with the participant to increase their soluble fibre intake by 2-3g each week during radiation treatment. Preliminary data will also be collected to look at the effect of an increased dietary (soluble) fibre diet on radiation-induced diarrhoea, nutritional status and quality of life. This will be a single arm single centre intervention feasibility trial, recruiting 40 participants from the RBWH radiation oncology outpatient department. Results from this study will determine whether increasing dietary fibre is realistic and safe to achieve in this setting, precluding any adverse effect on radiation treatment delivery.

Sponsors

University of Queensland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026