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

NCT04066894 | Terminated Phase 2 Results FDA Device

• 2 other identifiers: 2016-0754NCI-2019-02649
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.

Conditions

Low Anterior Resection Syndrome; Malignant Anal Neoplasm; Malignant Bladder Neoplasm; Malignant Cervical Neoplasm; Malignant Ovarian Neoplasm; Malignant Pelvic Neoplasm; Malignant Prostate Neoplasm; Malignant Uterine Neoplasm; Malignant Vaginal Neoplasm; Malignant Vulvar Neoplasm; Rectal Carcinoma

Outcome Measures

Primary Outcomes (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)

  Up to visit 3

Secondary Outcomes (10)

• Fecal Incontinence Severity Index Questionnaire Summary

  Up to 3 years

• Fecal Incontinence Quality of Life Questionnaire Summary

  Up to 3 years

• Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)

  Up to 3 years

• International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms

  Up to 3 years

• Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)

  Up to 3 years

Study Arms (1)

Supportive Care (sacral nerve stimulator)

EXPERIMENTAL

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.

Procedure: Explantation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Device: Sacral Nerve Stimulator; Device: Sacral Nerve Stimulator Battery; Procedure: Therapeutic Conventional Surgery

Interventions

Explantation PROCEDURE

Undergo lead removal

Supportive Care (sacral nerve stimulator)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (sacral nerve stimulator)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (sacral nerve stimulator)

Sacral Nerve Stimulator DEVICE

Undergo sacral nerve stimulator implantation

Also known as: Sacral Neuromodulator

Supportive Care (sacral nerve stimulator)

Sacral Nerve Stimulator Battery DEVICE

Undergo sacral nerve stimulator battery implantation

Also known as: Sacral Neuromodulator Battery

Supportive Care (sacral nerve stimulator)

Therapeutic Conventional Surgery PROCEDURE

Undergo sacral nerve stimulator implantation

Supportive Care (sacral nerve stimulator)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Anus Neoplasms; Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Pelvic Neoplasms; Prostatic Neoplasms; Uterine Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Rectal Neoplasms

Interventions

Device Removal

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Anus Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Craig Messick
• Organization: M D Anderson Cancer Center

cmessick@mdanderson.org

(713) 745-1544

Study Officials

• Craig A Messick, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: August 26, 2019
• Study Start: April 12, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Locations

US (2)