Sykehuset Telemark HF
Skien, Telemark, 3710, Norway
NCT Number: NCT06724198
Rectal cancer constitutes 1/3 of more than 4500 annually diagnosed cases of colorectal (CRC) in Norway. With the advances in radiochemotherapy, and surgical techniques, the long-term survival rate is increasing after surgery regardless of the rising incidences, with a 73% 5-year survival rate in Norway (89% for stage I-III cancer). Low anterior resection (LAR) is the most commonly performed surgical procedure with curative intent with over 500 procedures per year in Norway alone. 80 % of patients subjected to LAR suffer from the LAR syndrome (LARS) which includes grades of bowel incontinence, urgency and tenesmus contributing to reduced quality of life (QoL). Suggested means of management have been advocated without preceding randomized trials. Psyllium husk has been suggested as a nutritional supplement for symptom reduction in patients suffering from LARS, but data is limited and no larger, randomized studies regarding its effect on patients with low anterior resection syndrome have been conducted. In this pilot study preceeding a placebo-controlled RCT, the investigators aim to improve documentation of a proposed management strategy. The investigators anticipate that a reduction in intestinal symptomburden will increase QoL for this large patientgroup.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Skien, Telemark, 3710, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3.66 gram Psyllium husk twice daily for 8 weeks
Other names: Vi-Siblin, Metamucil, Fybogel
Time frame: At baseline, at 4 and 8 weeks of intervention
Low anterior resection syndrome score (0-42 points) 0-20: No LARS 21-29: Minor LARS 30-42: Major LARS
Time frame: At baseline, at 4 and 8 weeks of intervention
PROMs for self-evaluation of QoL:
EQ-5D-5L VAS score (0-100 were 0 is the worst possible health and lowest quality of life and 100 is the best possible health and highest quality of life)
Sykehuset Telemark
Other Gov
Quality of Life (QoL) and Symptom Burden After Low Rectal Resection. An Open, Effect Pilot Study With Psyllium Husk Treatment in Rectal Cancer Patients.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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