Anal CancerNCT01170299
Low-Fiber Diet or High-Fiber Diet in Preventing Bowel Side Effects in Patients Undergoing Radiation Therapy for Gynecological Cancer, Bladder Cancer, Colorectal Cancer, or Anal Cancer
A study testing dietary intervention, laboratory biomarker analysis and gastrointestinal complications management/prevention in people with Anal Cancer and Bladder Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel side effects caused by radiation therapy. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Anal Cancer, Bladder Cancer, Cervical Cancer
- What is being tested?
- dietary intervention, laboratory biomarker analysis and gastrointestinal complications management/prevention
- Type of treatment
- Surgery or procedure
- How many people
- 177 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of gynecological, urological (bladder), colorectal, or anal malignant cancer
- Scheduled to undergo a course of radical or adjuvant pelvic radiotherapy (≥ 45 Gy)
- Radiotherapy regimen will be delivered in daily fractions comprising approximately ≥ 25 fractions over 5-7 weeks
PATIENT CHARACTERISTICS:
- No prior prescribed low-residue diet for a clear medical reason
- No established wheat intolerance or celiac disease
- No concurrent condition precluding oral nutritional intake
PRIOR CONCURRENT THERAPY:
- No gastrointestinal stent
- No jejunostomy, ileostomy, or colostomy
- No concurrent participation in a study with toxicity as an endpoint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Investigate the Role of Low or High 'Fibre' Diets in Patients Undergoing Pelvic Radiotherapy - The Fibre Study
RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel side effects caused by radiation therapy.
PURPOSE: This randomized clinical trial is studying a high-fiber diet to see how well it works compared with a low-fiber diet in preventing bowel side effects in patients undergoing radiation therapy for gynecological cancer, bladder cancer, colorectal cancer, or anal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To compare the efficacy of a high- vs low-fiber intervention in preventing bowel toxicity in patients receiving radical pelvic radiotherapy treatment for gynecological, urological (bladder), colorectal, or anal malignancy.
- To compare whether a high- or low-fiber intervention has any beneficial effect over no intervention (i.e., ad-libitum fiber consumption).
- To examine the effect of a low- or high-fiber diet on gastrointestinal symptoms, measured using the IBDQ-B and Bristol Stool Chart, in patients receiving radical radiotherapy for pelvic malignancies.
- To minimize any potential risk associated with change in fiber intake by using a controlled and gradual dietary-based intervention combined with dietetic advice.
Secondary
- To examine the relationship between volume of irradiated bowel and onset of gastrointestinal symptoms as measured by the Bristol Stool Chart.
- To measure percentage compliance with fiber prescription through validated dietetic techniques including the 7-day Food Diary using household measures and the 24-hour recall.
OUTLINE: Patients are stratified according to disease (gynecological vs gastrointestinal) and concomitant therapy (received vs not received). Patients are randomized to 1 of 3 treatment arms.
- Arm I (low-fiber diet): Patients are assessed by a qualified dietitian, receive written guidance, and are counseled as to how best to meet their study fiber prescription of a low-fiber diet, comprising 'not more than' 10 g of fiber per day for up to 7 weeks.
- Arm II (high-fiber diet): Patients are assessed by a qualified dietitian, receive written guidance, and are counseled as to how best to meet their study fiber prescription of a high-fiber diet, comprising a target of between 18 and 22 g of fiber per day for up to 7 weeks.
- Arm III (no intervention): Patients receive advice designed to ensure they maintain their normal habitual diet for up to 7 weeks.
All patients undergo radiotherapy once daily comprising approximately 25 (or more) fractions in total to be delivered for 5-7 weeks in the absence of unacceptable toxicity.
All patients are asked to complete two 7-day Food Diaries at baseline and end of radiotherapy treatment. All patients keep a daily record of stool characteristics and frequency using the Bristol Stool Chart. Patients also complete a short 1-page weekly-cost questionnaire to assess the economic impact of symptom management. Patients in arms I and II complete several additional questions regarding the costs (if any) of adhering to their fiber prescription and the palatability of the diet.
Blood and stool samples may be collected at baseline and during study therapy for biomarker analysis.
After completion of study treatment, patients are followed up for up to 1 year.
- Conditions
- Anal Cancer, Bladder Cancer, Cervical Cancer, Colorectal Cancer, Fallopian Tube Cancer, Gastrointestinal Complications
- Being tested
- dietary intervention, laboratory biomarker analysis, gastrointestinal complications management/prevention, management of therapy complications, selective external radiation therapy
- Keywords
- radiation toxicity, gastrointestinal complications, cervical cancer, fallopian tube cancer, ovarian epithelial cancer, ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, uterine sarcoma, bladder cancer, colon cancer, rectal cancer, anal cancer
- Medical subject headings
- Anus Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Radiation Injuries, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary interventionDietary supplement
laboratory biomarker analysisOther
gastrointestinal complications management/preventionProcedure or surgery
management of therapy complicationsProcedure or surgery
selective external radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBDQ-B (Inflammatory Bowel Disease Questionnaire - Bowel Subset) score between baseline (i.e., Day 1 of radiotherapy treatment) and the nadir score during treatment
Secondary outcomes (2)
Incidence of toxicity, defined using the Bristol Stool Chart
Costs for symptom management
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Peter R. Blake, MD, Study chair, Royal Marsden NHS Foundation TrustJervoise Andreyev, MD, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170299
- Sponsor's protocol ID
- RM-FIBRE-STUDY
- Other IDs
- CDR0000681693, RM-CCR-3142, EU-21053
- Status last verified
- Jul 2010
- First submitted
- 24 Jul 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Investigate the Role of Low or High 'Fibre' Diets in Patients Undergoing Pelvic Radiotherapy - The Fibre Study
- ClinicalTrials.gov ID
- NCT01170299
- Acronym / sponsor ID
- RM-FIBRE-STUDY
- Conditions
- Anal Cancer, Bladder Cancer, Cervical Cancer, Colorectal Cancer, Fallopian Tube Cancer, Gastrointestinal Complications
- Keywords
- radiation toxicity, gastrointestinal complications, cervical cancer, fallopian tube cancer, ovarian epithelial cancer, ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel side effects caused by radiation therapy.
PURPOSE: This randomized clinical trial is studying a high-fiber diet to see how well it works compared with a low-fiber diet in preventing bowel side effects in patients undergoing radiation therapy for gynecological cancer, bladder cancer, colorectal cancer, or anal cancer.
Detailed description
OBJECTIVES:
Primary
- To compare the efficacy of a high- vs low-fiber intervention in preventing bowel toxicity in patients receiving radical pelvic radiotherapy treatment for gynecological, urological (bladder), colorectal, or anal malignancy.
- To compare whether a high- or low-fiber intervention has any beneficial effect over no intervention (i.e., ad-libitum fiber consumption).
- To examine the effect of a low- or high-fiber diet on gastrointestinal symptoms, measured using the IBDQ-B and Bristol Stool Chart, in patients receiving radical radiotherapy for pelvic malignancies.
- To minimize any potential risk associated with change in fiber intake by using a controlled and gradual dietary-based intervention combined with dietetic advice.
Secondary
- To examine the relationship between volume of irradiated bowel and onset of gastrointestinal symptoms as measured by the Bristol Stool Chart.
- To measure percentage compliance with fiber prescription through validated dietetic techniques including the 7-day Food Diary using household measures and the 24-hour recall.
OUTLINE: Patients are stratified according to disease (gynecological vs gastrointestinal) and concomitant therapy (received vs not received). Patients are randomized to 1 of 3 treatment arms.
- Arm I (low-fiber diet): Patients are assessed by a qualified dietitian, receive written guidance, and are counseled as to how best to meet their study fiber prescription of a low-fiber diet, comprising 'not more than' 10 g of fiber per day for up to 7 weeks.
- Arm II (high-fiber diet): Patients are assessed by a qualified dietitian, receive written guidance, and are counseled as to how best to meet their study fiber prescription of a high-fiber diet, comprising a target of between 18 and 22 g of fiber per day for up to 7 weeks.
- Arm III (no intervention): Patients receive advice designed to ensure they maintain their normal habitual diet for up to 7 weeks.
All patients undergo radiotherapy once daily comprising approximately 25 (or more) fractions in total to be delivered for 5-7 weeks in the absence of unacceptable toxicity.
All patients are asked to complete two 7-day Food Diaries at baseline and end of radiotherapy treatment. All patients keep a daily record of stool characteristics and frequency using the Bristol Stool Chart. Patients also complete a short 1-page weekly-cost questionnaire to assess the economic impact of symptom management. Patients in arms I and II complete several additional questions regarding the costs (if any) of adhering to their fiber prescription and the palatability of the diet.
Blood and stool samples may be collected at baseline and during study therapy for biomarker analysis.
After completion of study treatment, patients are followed up for up to 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary intervention | Dietary supplement | – |
| laboratory biomarker analysis | Other | – |
| gastrointestinal complications management/prevention | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| selective external radiation therapy | Radiation | – |
Primary outcome
Change in IBDQ-B (Inflammatory Bowel Disease Questionnaire - Bowel Subset) score between baseline (i.e., Day 1 of radiotherapy treatment) and the nadir score during treatment
2 secondary outcomes
Incidence of toxicity, defined using the Bristol Stool Chart
Costs for symptom management
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter R. Blake, MD study chair
Royal Marsden NHS Foundation Trust
Jervoise Andreyev, MD
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention, laboratory biomarker analysis and gastrointestinal complications management/prevention in people with Anal Cancer and Bladder Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IBDQ-B (Inflammatory Bowel Disease Questionnaire - Bowel Subset) score between baseline (i.e., Day 1 of radiotherapy treatment) and the nadir score during treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.