Dietary Fibre Supplementation to Delay Disease Progression in Early Prostate Cancer

NCT07790003 | Completed DMC

• 1 other identifier: 1234567890
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This qualitative research study, based on semi-structured interviews and a focus group, aims to explore the attitudes of prostate cancer patients on active surveillance (AS) towards dietary fibre supplementation, given the potential benefits demonstrated in previous research. Prostate cancer patients on AS, often overlooked in the literature, experience cyclical anxiety, particularly regarding disease progression. Lifestyle modifications, including dietary changes, are pursued by a number of these patients as a preventative measure. Dietary fibre such as inulin and psyllium have promising results in studies of pelvic cancers. However, it is important to note that these findings do not directly apply to patients who are currently undergoing AS for prostate cancer. Despite potential side effects, these dietary fibres may contribute to anti-inflammatory and antitumorigenic effects. Building on this evidence, we aim to explore patient perspectives on the feasibility and acceptability of dietary fibre supplementation during AS. The insights gained will guide the development of a feasibility and/or pilot studies and, subsequently, a multicentre randomised controlled trial. If successful, this intervention could potentially reshape clinical practice for patients with prostate cancer on AS.

Conditions

Prostate Cancer; Prostatic Neoplasm; Dietary Fibre Modification; Active Surveillance

Keywords

Active Surveillance; Dietary Fibre Modification; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Attitudes and preferences of men on active surveillance for prostate cancer regarding dietary supplementation.

  Semi-structured interviews will explore men's views on incorporating dietary fibre supplementation (inulin with or without psyllium), into active surveillance for prostate cancer. Responses will be analysed thematically using the Theoretical Framework of Acceptability.

  At a single interview following enrolment (approximately 30-45 minutes)

Secondary Outcomes (1)

• Barriers/facilitators to dietary fibre adherence during active surveillance

  At a single interview following enrolment (approximately 30-45 minutes)

Study Arms (1)

Patients with prostate cancer on active surveillance.

Qualitative semi-structured interviews and a focus group with patients who have prostate cancer and are currently on active surveillance. Intervention: Other: Qualitative interviews and focus group.

Other: Qualitative semi-structured interviews; Other: Focus group

Interventions

Qualitative semi-structured interviews OTHER

The research fellow will conduct a total of 12 semi-structured individual interviews, either via video (MS Teams) or telephone format, based on participant preference. We will employ a semi-structured interview methodology as it collects richer data and allows for in-depth exploration of the participant's insights. Interviews will be conducted at a time convenient to the participant. The topic guide will structure the interview format. Each participant will be interviewed only once.

Patients with prostate cancer on active surveillance.

Focus group OTHER

Subsequently, we will hold one focus group online via video (MS Teams) with six participants, which will be run by the research fellow and one of the academic supervisors. The topic guide will structure the interview format.

Patients with prostate cancer on active surveillance.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men on active surveillance for prostate cancer from North-East Scotland.

You may qualify if:

• Participants over 18 years of age.
• Participants with residence in North-East Scotland.
• Participants must be fluent in the English language.
• Participants on active surveillance.

You may not qualify if:

• Participants who do not speak fluent English will be excluded from this study.
• Participants who were treated with surgery, radiotherapy, chemotherapy or anti-androgen therapy for their prostate cancer.
• Vulnerable participants, classified as adults who do not have the capacity to consent for themselves, will not be included in the study. If the research team are made aware that someone has lost capacity then they will be withdrawn from the study.

Sponsors & Collaborators

• University of Aberdeen: lead
• Friends of ANCHOR: collaborator

Study Sites (1)

NHS Grampian - Aberdeen Royal Infirmary

Aberdeen, Aberdeen City, AB25 2ZD, United Kingdom

Location

Related Publications (11)

• Van Hemelrijck M, Ji X, Helleman J, Roobol MJ, van der Linden W, Nieboer D, Bangma CH, Frydenberg M, Rannikko A, Lee LS, Gnanapragasam VJ, Kattan MW; Members of the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 consortium; Members of the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 consortium. Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium. Eur Urol. 2019 Mar;75(3):523-531. doi: 10.1016/j.eururo.2018.10.025. Epub 2018 Oct 29.

  PMID: 30385049 BACKGROUND

• Daubenmier JJ, Weidner G, Marlin R, Crutchfield L, Dunn-Emke S, Chi C, Gao B, Carroll P, Ornish D. Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance. Urology. 2006 Jan;67(1):125-30. doi: 10.1016/j.urology.2005.07.056.

  PMID: 16413347 BACKGROUND

• Dovey Z, Horowitz A, Waingankar N. The influence of lifestyle changes (diet, exercise and stress reduction) on prostate cancer tumour biology and patient outcomes: A systematic review. BJUI Compass. 2023 Apr 6;4(4):385-416. doi: 10.1002/bco2.237. eCollection 2023 Jul.

  PMID: 37334023 BACKGROUND

• Bishehsari F, Engen PA, Preite NZ, Tuncil YE, Naqib A, Shaikh M, Rossi M, Wilber S, Green SJ, Hamaker BR, Khazaie K, Voigt RM, Forsyth CB, Keshavarzian A. Dietary Fiber Treatment Corrects the Composition of Gut Microbiota, Promotes SCFA Production, and Suppresses Colon Carcinogenesis. Genes (Basel). 2018 Feb 16;9(2):102. doi: 10.3390/genes9020102.

  PMID: 29462896 BACKGROUND

• Carretta MD, Quiroga J, Lopez R, Hidalgo MA, Burgos RA. Participation of Short-Chain Fatty Acids and Their Receptors in Gut Inflammation and Colon Cancer. Front Physiol. 2021 Apr 8;12:662739. doi: 10.3389/fphys.2021.662739. eCollection 2021.

  PMID: 33897470 BACKGROUND

• Tan J, McKenzie C, Potamitis M, Thorburn AN, Mackay CR, Macia L. The role of short-chain fatty acids in health and disease. Adv Immunol. 2014;121:91-119. doi: 10.1016/B978-0-12-800100-4.00003-9.

  PMID: 24388214 BACKGROUND

• Kruse HP, Kleessen B, Blaut M. Effects of inulin on faecal bifidobacteria in human subjects. Br J Nutr. 1999 Nov;82(5):375-82. doi: 10.1017/s0007114599001622.

  PMID: 10673910 BACKGROUND

• Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.

  PMID: 34353864 BACKGROUND

• Li Y, Elmen L, Segota I, Xian Y, Tinoco R, Feng Y, Fujita Y, Segura Munoz RR, Schmaltz R, Bradley LM, Ramer-Tait A, Zarecki R, Long T, Peterson SN, Ronai ZA. Prebiotic-Induced Anti-tumor Immunity Attenuates Tumor Growth. Cell Rep. 2020 Feb 11;30(6):1753-1766.e6. doi: 10.1016/j.celrep.2020.01.035.

  PMID: 32049008 BACKGROUND

• Then CK, Paillas S, Wang X, Hampson A, Kiltie AE. Association of Bacteroides acidifaciens relative abundance with high-fibre diet-associated radiosensitisation. BMC Biol. 2020 Aug 19;18(1):102. doi: 10.1186/s12915-020-00836-x.

  PMID: 32811478 BACKGROUND

• Murphy J, Stacey D, Crook J, Thompson B, Panetta D. Testing control of radiation-induced diarrhea with a psyllium bulking agent: a pilot study. Can Oncol Nurs J. 2000 Summer;10(3):96-100. doi: 10.5737/1181912x10396100.

  PMID: 11894282 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: August 27, 2026
• Study Start: July 3, 2024
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: August 27, 2026

Record last verified: 2026-05

Locations

GB (1)