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
Condition: 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
MeSH terms: Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Uterine Neoplasms; Vulvar Neoplasms; Pelvic Neoplasms; Vaginal Neoplasms; Anus Neoplasms; Fecal Incontinence; Low Anterior Resection Syndrome; Syndrome
Intervention: Explantation; Quality-of-Life Assessment; Questionnaire Administration; Sacral Nerve Stimulator; Sacral Nerve Stimulator Battery; Therapeutic Conventional Surgery
Intervention description: Undergo lead removal; Ancillary studies; Ancillary studies; Undergo sacral nerve stimulator implantation; Undergo sacral nerve stimulator battery implantation; Undergo sacral nerve stimulator implantation
Intervention MeSH terms: Neurotransmitter Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  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

        Exclusion Criteria:

          -  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

          -  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