Hyaluronic Acid-based Gel Spacer to Reduce Injury to Health Tissue during Brachytherapy for Cervical Cancer

Inclusion Criteria

• Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
• Subject is willing and able to comply with study procedures based on the judgement of the investigator
• Age ≥ 18 years at the time of consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky Performance Scale score of 50-100
• Histological or cytological evidence of cervical cancer. Only patients with cervical cancer who are planned for chemoRT with brachytherapy except for individuals with known rectal invasion (per SOC physical exam-based assessments or SOC radiographic evaluation) are eligible. There is no minimum number of required chemotherapy cycles, patients who are planned for chemotherapy but not able to tolerate or be administered per provider discretion will remain eligible for inclusion. Immunotherapy given in the neoadjuvant, concurrent and/or adjuvant setting is permitted
• Subjects with well-controlled human immunodeficiency virus (HIV) infection are eligible, provided no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
• Hemoglobin (Hgb) ≥ 6 g/dL (within 21 days prior to initiating study treatment)
• White blood cell (WBC) ≥ 1.0 x 10^9/L (within 21 days prior to initiating study treatment)
• Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L (within 21 days prior to initiating study treatment)
• Platelets ≥ 50 x 10^9/L (within 21 days prior to initiating study treatment)
• Creatinine ≤ 2.0 x upper limit of normal (ULN) (within 21 days prior to initiating study treatment)
• Note: Hematology and other lab parameters that are ≥ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
• Females of childbearing potential must have a documented negative serum or urine pregnancy test prior to initiation of EBRT per standard of care. If a patient has undergone EBRT at an external facility, a pregnancy test at UNC is not required * NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided

Exclusion Criteria

• Active infection requiring systemic therapy
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
• Known allergy to hyaluronic acid-based products
• Known inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• History of prior low anterior or abdominal perineal resections or anorectal surgery
• History of rectal/anal fistula
• Prior pelvic radiation excluding partial course radiation therapy (RT) delivered for management of the present disease (example short course palliative RT bridging to chemoRT and brachytherapy)
• Active connective tissue disorder
• History of uncontrolled diabetes (e.g., symptomatic hyperglycemia that is not controlled with medical management, fasting blood glucose level above 300 mg/dL)
• Active bleeding disorder or clinically significant coagulopathy defined as partial thromboplastin time (PTT) > 35 seconds or international normalized ratio (INR) > 1.4 (unless treating provider deems acceptable to hold anticoagulation therapy for a sufficient period at the time of injection)
• Subjects with contraindication for MRI
• Subjects with pre-existing anorectal conditions such as fissures, stenosis, or other malformations should be excluded or receive consultation from a colorectal surgeon prior to enrollment