Rectal CancerPhase 2/3NCT02163187

Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

A Phase 2/3 study testing Implantation of the InterStimTM, MSK BFI questionnaires and The Low Anterior Resection Score (LARS) questionnaires in people with Rectal Cancer and for Bowel Dysfunction Following Surgery for Rectal Cancers, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rectal Cancer, for Bowel Dysfunction Following Surgery for Rectal Cancers
What is being tested?: Implantation of the InterStimTM, MSK BFI questionnaires and The Low Anterior Resection Score (LARS) questionnaires
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 2 sitesUnited States
Study dates: 10 Jun 2014to 19 Dec 2016
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of rectal cancer or neoplastic polyp (i.e. intramucosal carcinoma, carcinoma in situ)
BFI score must meet at least one of the below criteria:
Total BFI < 50
Dietary subscale < 11
Frequency subscale < 19
Urgency subscale < 12

Show all 9Show fewer

English speaking
Patients ≥18 years old. age
Sphincter-preserving surgery and ≥ 12 months after restoration of bowel continuity

Who cannot join

Locally recurrent or metastatic disease
Immune suppressive medication
Seizure disorder
Prior sacral/lower spinal surgery
Congenital Spinal defect/Paraplegia
Rectal prolapse

Show all 13Show fewer

IBD/Crohn's
Pregnancy
Active anal/rectal abscess
Pacemaker or other electronic implanted device
Immediate need for MRI
At the time of the wire stimulation procedure, patients will be excluded if the surgeon is unable to place the temporary stimulating lead
Inability to commit to local follow up for device management.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Medical College of Cornell University
New York, New York, 10065

Other trials in United States

About this study

Official title: Randomized Crossover Study of the Efficacy of Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device. Neuromodulation is a way of changing the activity of the nervous system by using electrical stimulation. InterStimTM is FDA approved to help people who have a hard time controlling their bowl movements. This is called fecal incontinence.The device is placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is initially tested to make sure it will work using a temporary wire and then, if successful, the device is permanently implanted.

Read the detailed description

This is a single-blind randomized crossover study. After providing written informed consent, eligible patients will undergo an initial stimulation procedure with a temporary lead (Step 1 Wire Stimulation). The simulation is performed to determine efficacy of the device before a permanent implant is placed. This stimulation takes place over a period of 7-14 days (+/-3 days). Because this procedure is done in the OR, this window of time allows for optimization of the device and coordination of operating room schedules. This is the time period that has been used in prior trials. Typically bowel improvement has been seen relatively quickly, so the range should not affect our assessment of BFI.

After the Wire Implantation has occurred, patients will be evaluated over the next 7-14 days (+/- 3 days) and will complete the BFI questionnaire. If BFI improvement is < than or = to 4 points the wire will be removed in the operating room, the patient will be offered standard of care, and the patient will no longer be part of the study. Based on our prior data, we would like to give as many patients as possible the opportunity for enrollment and as a result we have chosen a 4 point BFI change as minimum criteria for response. Our group has seen that a change in the BFI around 5-6 is clinically significant, but we will lower this threshold slightly. If a patient's BFI improves by ≥ 4 points, the patient will proceed to the randomized phase (Step 2-Implantation) of the study.

Patients who proceed to Step 2- Implantation, they will return to the operating room for the implantation of the permanent device. While in the operating room they will be randomly assigned to either having the device stimulation on (Group A) or device stimulation off (Group B) for first 4 weeks (+/-3 days). Patients will return to clinic 2 weeks later to cross over to the other arm (Step 3-Crossover) and the device stimulation will be set to on or off. Patients will come back to clinic within 7 days (+/- 7 days) after Crossover for device check and optimization.

Conditions: Rectal Cancer, for Bowel Dysfunction Following Surgery for Rectal Cancers
Being tested: Implantation of the InterStimTM, MSK BFI questionnaires, The Low Anterior Resection Score (LARS) questionnaires, The EuroQOL5D questionnaires, The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires
Keywords: Neuromodulation (SNM), sphincter preservation, rectal polyp, InterStimTM, 14-100
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantation of the InterStimTMDevice
MSK BFI questionnairesBehavioural
The Low Anterior Resection Score (LARS) questionnairesBehavioural
The EuroQOL5D questionnairesBehavioural
The Fecal incontinence Quality of Life Scale (FIQOL) questionnairesBehavioural

Study groups in NCT02163187
Study group	Role	What they receive
InterStimTM the device on	Experimental	The device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks. Receives: Device: Implantation of the InterStimTM; Behavioral: MSK BFI questionnaires; Behavioral: The Low Anterior Resection Score (LARS) questionnaires; Behavioral: The EuroQOL5D questionnaires; Behavioral: The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires
InterStimTM the device off	Experimental	The device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks. Receives: Device: Implantation of the InterStimTM; Behavioral: MSK BFI questionnaires; Behavioral: The Low Anterior Resection Score (LARS) questionnaires; Behavioral: The EuroQOL5D questionnaires; Behavioral: The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Bowel Function
Bowel function will be assessed by using the MSK BFI. We have chosen the BFI because it is widely endorsed to assess the clinical problem that these patients have. The BFI is a 19 item instrument to which a patient responds using a 5-point Likert scale, ranging from Always to Never.
Measured: 3 years

Secondary outcomes (1)

Quality of Life
QOL and urinary continence will be assessed at the start of the study (Baseline), after initial stimulation (Step 1-Wire Stimulation), and at each point in the crossover trial (Step 2-Implantation and Step 3-Crossover). Graphical displays will be used to explore data distributions of all secondary outcome measures over time. We assume no period effect and will evaluate the treatment effect using the paired t-test (and a repeated measures ANOVA to include other covariates in the model) for each of our main outcome measures, EuroQOL5, FIQOL, LARS and Bladder function. We will test for period effect to confirm this.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 201419 Dec 2016

First posted13 Jun 2014 (estimated)
Study start10 Jun 2014
Primary completion19 Dec 2016
Study completion19 Dec 2016

Why it stopped: Study permanently closed due to low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rectal CancerStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer CenterThe 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02163187
Sponsor's protocol ID: 14-100
Status last verified: Jan 2017
First submitted: 11 Jun 2014
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Crossover Study of the Efficacy of Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
ClinicalTrials.gov ID: NCT02163187
Acronym / sponsor ID: 14-100
Conditions: Rectal Cancer, for Bowel Dysfunction Following Surgery for Rectal Cancers
Keywords: Neuromodulation (SNM), sphincter preservation, rectal polyp, InterStimTM, 14-100
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study permanently closed due to low accrual
Enrolment: 4 participants (actual)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Collaborators: Weill Medical College of Cornell University
Study start: 10 Jun 2014
Primary completion: 19 Dec 2016 (actual)
Study completion: 19 Dec 2016 (actual)
First posted: 13 Jun 2014 (estimated)
Results: Posted 13 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
InterStimTM the device on	Experimental	Device: Implantation of the InterStimTM, Behavioral: MSK BFI questionnaires, Behavioral: The Low Anterior Resection Score (LARS) questionnaires, Behavioral: The EuroQOL5D questionnaires, Behavioral: The Fecal incontinence Quality of Life Scale (FIQOL) questionnairesThe device will be set to stimulate for 4 weeks, then off for two weeks, and then the device will be on but will not stimulate for 4 weeks.
InterStimTM the device off	Experimental	Device: Implantation of the InterStimTM, Behavioral: MSK BFI questionnaires, Behavioral: The Low Anterior Resection Score (LARS) questionnaires, Behavioral: The EuroQOL5D questionnaires, Behavioral: The Fecal incontinence Quality of Life Scale (FIQOL) questionnairesThe device will be on but will not stimulate for 4 weeks, then off for two weeks, and then the device will be set to stimulate for 4 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

History of rectal cancer or neoplastic polyp (i.e. intramucosal carcinoma, carcinoma in situ)
BFI score must meet at least one of the below criteria:
English speaking
Patients ≥18 years old. age
Sphincter-preserving surgery and ≥ 12 months after restoration of bowel continuity

Key exclusion criteria (13 listed)

Locally recurrent or metastatic disease
Immune suppressive medication
Seizure disorder
Prior sacral/lower spinal surgery
Congenital Spinal defect/Paraplegia

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
Implantation of the InterStimTM	Device	InterStimTM the device off, InterStimTM the device on
MSK BFI questionnaires	Behavioural	InterStimTM the device off, InterStimTM the device on
The Low Anterior Resection Score (LARS) questionnaires	Behavioural	InterStimTM the device off, InterStimTM the device on
The EuroQOL5D questionnaires	Behavioural	InterStimTM the device off, InterStimTM the device on
The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires	Behavioural	InterStimTM the device off, InterStimTM the device on

Primary outcome

Change in Bowel Function
Time frame: 3 years
Bowel function will be assessed by using the MSK BFI. We have chosen the BFI because it is widely endorsed to assess the clinical problem that these patients have. The BFI is a 19 item instrument to which a patient responds using a 5-point Likert scale, ranging from Always to Never.

1 secondary outcome

Quality of Life
Time frame: 3 years

Results and safety

Results posted to the registry on 13 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
InterStimTM the Device on, Then InterStimTM Device Off	4	2
InterStimTM the Device Off, Then InterStimTM Device on	0	0

Primary outcome: Change in Bowel Function

Time frame: 3 years

Population analysed: Study terminated early due to low accrual. Data were not collected.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
InterStimTM the Device on	0 of 0	0 of 0	Not reported
InterStimTM the Device Off	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.

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Not yet recruitingPhase 2
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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.

Larissa Temple, MD principal investigator

Memorial Sloan Kettering Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. 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: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Bowel Function (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02163187.

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 5 Feb 2018.