Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer

NCT01653327 | Completed Phase 2 Results DMC

• 1 other identifier: D1022
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

• The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis.
• The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.

Conditions

Mucositis; Head and Neck Cancer

Keywords

mucositis; head and neck; cancer; radiation therapy; chemoradiation; oral; pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score

  The primary analysis is testing and estimating the effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will determine average pain scores. Pain will be measured using a 0-10 scale with 0 representing no pain; 1-3 representing mild pain; 4-6 representing moderate pain; and 7-10 representing severe pain. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval. Proportional changes in pain scores (post-treatment pain score ÷ pre-treatment pain score) will be calculated and similarly analyzed. The proportion of subjects experiencing a reduction in pain scores of \>33% will be calculated.

  After 9-10 doses, expected average 1 month

Secondary Outcomes (1)

• Duration of Analgesic Effect

  After 9-10 doses, expected average 1 month

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.

Drug: Placebo

Interventions

Ketamine DRUG

Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.

Ketamine

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects diagnosed with head and neck tumors (any histology) receiving ongoing chemoradiation or radiation therapy
• Subjects with mucositis pain refractory to topical management, defined as any self-reported pain score of \> 2 in the 24 hours prior to enrollment despite use of topical agents as prescribed
• Age ≥ 18 years
• Ability to understand and willingness to consent and to sign consent form

You may not qualify if:

• Active substance abuse at time of registration (alcohol, drugs, non-prescription use of controlled substances)
• Subjects with history of allergic reactions to ketamine
• Persistent oral bleeding: \> 15 mL (estimated) per day
• Pregnancy or breast feeding

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Mucositis; Head and Neck Neoplasms; Neoplasms; Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Thomas Davis
• Organization: Dartmouth-Hitchcock Medical Center

Thomas.H.Davis@hitchcock.org

1-603-650-8626

Study Officials

• Thomas H David, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 31, 2012
• Study Start: June 1, 2010
• Primary Completion: August 16, 2016
• Study Completion: August 16, 2016
• Last Updated: September 28, 2018
• Results First Posted: September 28, 2018

Record last verified: 2018-09

Locations

US (1)