RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer

Conditions

• Oral Mucositis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RRx-001 — DRUG
  RRx-001 for injection (4 mg or 8 mg)
• Intensity Modulated Radiation Therapy (IMRT) — RADIATION
  Intensity Modulated Radiation Therapy of up to 72 Gy
• Cisplatin for injection 100 mg/m2 — DRUG
  Cisplatin for injection 100 mg/m2

Study Details

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.

Key Dates

Start date

Apr 2, 2024

Status verified

Nov 2024

Primary completion

Jul 1, 2025

Completion

Oct 1, 2025

Study Design

Enrollment

216 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
  Pretreatment consists of 8 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period
• Experimental: RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
  Pretreatment consists of 4 mg RRx-001 given twice weekly during the 2 weeks prior to the start of CRT (4 doses total) followed by the CRT treatment period.
• Placebo Comparator: Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
  No doses of RRx-001 will be administered. Patients assigned to this arm will receive placebo twice weekly during the 2 weeks prior to the start of CRT followed by the CRT treatment period.

Primary Outcome Measure

Incidence of Severe Oral Mucositis (SOM) through Intensity-modulated radiation therapy (IMRT) [ Time Frame: Estimated up to 18 Months ]

Central Contacts

• Scott Caroen
  8589476635
  [email protected]
• Jeannie Williams
  8589476635
  [email protected]

Locations (14)

Find similar trials in Gilbert, AZ

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