AzTrials
AzTrials

Low Anterior Resection SyndromePhase 2NCT04066894

Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study

A Phase 2 study testing Explantation, Quality-of-Life Assessment and Questionnaire Administration in people with Low Anterior Resection Syndrome and Malignant Anal Neoplasm, run by M.D. Anderson 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
Search all trials

Trial summary

This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Explantation, Quality-of-Life Assessment and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
12 Apr 2019to 1 Sep 2022
Phase
Phase 2
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

  • Cohort 1: Patients with pathologically proven diagnosis of primary rectal cancer
  • Cohort 1: Patients who have previously undergone surgical resection and anastomosis (restorative) with curative intent treatment with or without chemoradiation
  • Cohort 1: Patients treated with restorative surgical resection without radiation
  • Cohort 1: Patients with any T-stage or N-stage rectal cancer that underwent treatment with radiation and restorative surgery
  • Cohort 1: Patients with self-reported FI or LARS
  • Cohort 1: Patients must be at least 18 years old and be able to speak and understand English
Show all 22Show fewer
  • Cohort 1: Patients must be willing to and able to sign an approved informed consent document
  • Cohort 1: Patients must be >= 24 months post-resection of rectal cancer
  • Cohort 1: Patients must have failed prior conservative measures such as Metamucil and motility medications and already been assessed and treated in a pelvic floor rehabilitation program (biofeedback) designed to treat FI and LARS, and continue to experience significant defecatory dysfunction, allowable per principal investigator (PI) discretion
  • Cohort 1: Patients must be willing and able to complete Patient Reported Outcomes Questionnaires for before device placement, during the testing phase following lead placement, and after implantation of the battery
  • Cohort 1: Patients must be willing and able to undergo elective ARM testing to objectively measure pelvic floor function
  • Cohort 1: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM
  • Cohort 2: Patients with pathologically proven malignancy of the pelvis, other than rectal cancer (e.g. prostate, bladder, anus, vagina, vulva, cervix, uterus, or ovary)
  • Cohort 2: Patients treated with standard of care radiation therapies without surgical resection
  • Cohort 2: Patients with self-reported FI or other defecatory dysfunction
  • Cohort 2: Patients must be at least 18 years old and be able to speak and understand English
  • Cohort 2: Patients must be willing to and able to sign an approved informed consent document
  • Cohort 2: Patients must be >= 18 months post-pelvic chemoradiation
  • Cohort 2: Patients must have already been assessed and treated in a pelvic floor rehabilitation program design to treat FI or other defecatory dysfunction and continue to experience significant defecatory dysfunction
  • Cohort 2: Patients must be willing and able to complete Patient Reported Outcomes (PROs) and bowel and bladder diaries (Medtronic) at multiple times during the study
  • Cohort 2: Patients must be willing and able to undergo elective ARM testing to measure pelvic floor function
  • Cohort 2: Patients who have an average resting tone < 40 mmHg (normal > 40 mmHg) and maximal tolerance < 200 milliliters (normal 200-300 milliliters) as measured by ARM

Who cannot join

  • Cohort 1: Patients with co-morbid illnesses or concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Cohort 1: Any diverting bowel ostomy at the time of consent to this study
  • Cohort 1: Patients with an absolute neutrophil count (ANC) < 1.7 within 30 days of consent
  • Cohort 1: Patients with an international normalized rate (INR) > 1.3 within 30 days of consent
  • Cohort 1: Patients with a platelet count < 50 K within 30 days of consent
  • Cohort 1: Patients currently being treated with chemotherapy or within preceding 30 days at the time consent
Show all 21Show fewer
  • Cohort 1: Patients previously treated with a SNS for urinary or FI
  • Cohort 1: Patients who were documented to have an anastomotic leak following their restorative surgical resection
  • Cohort 1: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status > 2 at the time of consent
  • Cohort 1: Patients with an active infection requiring systemic therapy at the time of consent
  • Cohort 1: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
  • Cohort 2: Co-morbid illnesses or other concurrent disease, which in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Cohort 2: Patients with an ANC < 1.7 within 30 days of consent
  • Cohort 2: Patients with an INR > 1.3 within 30 days of consent
  • Cohort 2: Patients with a platelet count < 50 K, within 30 days of consent
  • Cohort 2: Patients currently being treated with chemotherapy or within the preceding 30 days at the time of consent
  • Cohort 2: Patients previously treated with a sacral nerve stimulator for urinary or fecal incontinence
  • Cohort 2: Patients with an ECOG performance status > 2 at the time of consent
  • Cohort 2: Patients with an active infection requiring systemic therapy at the time of consent
  • Cohort 2: Patients with a significant history of uncontrolled cardiac disease including, but not limited to hypertension, unstable angina, myocardial infarction within the last 4 months, and uncontrolled congestive heart failure
  • Cohort 2: Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

Other trials in United States

About this study

Official title: A Phase II Study of Sacral Nerve Stimulation for Low Anterior Resection Syndrome or Fecal Incontinence in Patients Following a Low Anterior Resection or Proctectomy With Coloanal Anastomosis or in Patients After Pelvic Chemoradiation (RESTORE)

This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To investigate the efficacy of sacral nerve stimulator placement in patients with fecal incontinence (FI) or low anterior resection syndrome (LARS) who have previously undergone chemoradiation treatment (XRT) and/or a restorative partial or complete proctectomy with colorectal or coloanal anastomosis for cancer treatment as per standard of care (restorative surgery cohort).

II. To evaluate the feasibility of sacral nerve stimulator placement in patients with fecal incontinence (FI) or other defecatory dysfunction who have received pelvic radiation treatment without undergoing rectal or other pelvic surgery as per standard of cancer care (radiation only cohort).

SECONDARY OBJECTIVES:

  1. To evaluate the effectiveness of sacral nerve stimulation (SNS) as measured by validated questionnaires in patients with FI or LARS within both patient cohorts.

II. To evaluate pelvic floor and sphincter physiology using anorectal manometry (ARM) before and after SNS in patients with FI or LARS within both patient cohorts.

III. To assess potential impact of SNS on urinary incontinence measuring a post-void urinary bladder residual and validated urinary symptom questionnaires in both patient cohorts.

IV. To assess efficacy of SNS on long-term bowel dysfunction at 1 and 3 years post battery implantation as measured by validated questionnaires for both patient cohorts.

OUTLINE:

Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.

After completion of study, patients are followed up at 1 month, 1 year, and 3 years.

Being tested
Explantation, Quality-of-Life Assessment, Questionnaire Administration, Sacral Nerve Stimulator, Sacral Nerve Stimulator Battery
Medical subject headings
Low Anterior Resection Syndrome, Anus Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Pelvic Neoplasms, Prostatic Neoplasms, Uterine Neoplasms

What participants receive

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

  • ExplantationProcedure or surgery

    Undergo lead removal

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Sacral Nerve StimulatorDevice

    Also called Sacral Neuromodulator

    Undergo sacral nerve stimulator implantation

  • Sacral Nerve Stimulator BatteryDevice

    Also called Sacral Neuromodulator Battery

    Undergo sacral nerve stimulator battery implantation

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo sacral nerve stimulator implantation

Study groups in NCT04066894
Study groupRoleWhat they receive
Supportive Care (sacral nerve stimulator)ExperimentalPatients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
Receives: Procedure: Explantation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: Sacral Nerve Stimulator; Device: Sacral Nerve Stimulator Battery; Procedure: Therapeutic Conventional Surgery

What is being measured

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

  1. Sacral Nerve Stimulation (SNS) Success

    SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)

    Measured: Up to visit 3

Secondary outcomes (10)

  1. Fecal Incontinence Severity Index Questionnaire Summary

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

  2. Fecal Incontinence Quality of Life Questionnaire Summary

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

  3. Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

  4. International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

  5. Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

  6. Low Anterior Resection Syndrome Score BFQ

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

  7. Cleveland Clinic Incontinence Score

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

  8. Impact of SNS on Bowel Dysfunction

    Will be measured using bowel diaries.

    Measured: Up to 30 days (visit 2)

  9. Impact of SNS on Urinary Incontinence

    Will be measured using bladder diaries and a post-void urinary bladder residual and validated urinary symptom questionnaire.

    Measured: Up to 30 days (visit 2)

  10. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29

    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

    Measured: Up to 3 years

Timeline

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

  1. First posted26 Aug 2019
  2. Study start12 Apr 2019
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Why it stopped: Due to Issues Enrolling Patients

Resources

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
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066894
Sponsor's protocol ID
2016-0754
Other IDs
NCI-2019-02649, 2016-0754
Status last verified
Jul 2023
First submitted
11 Jun 2019
Last updated
14 Aug 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Explantation, Quality-of-Life Assessment and Questionnaire Administration in people with Low Anterior Resection Syndrome and Malignant Anal Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.

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 22 inclusion and 21 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 14 Aug 2023. 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 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.

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 14 Aug 2023). 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?

Sacral Nerve Stimulation (SNS) Success (time frame: Up to visit 3). 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 NCT04066894.

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 14 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in