Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy

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Brief Title

Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy

Official Title

A Pilot, Double-Blind, Randomized, Two-Arm Crossover Study of Doxepin Versus Placebo for Esophagitis-Induced Pain in Patients Receiving Radiotherapy to the Thorax With or Without Chemotherapy

Brief Summary

      This randomized pilot clinical trial studies the effects of taking doxepin hydrochloride as
      compared to placebo (inactive drug) in treating esophageal pain in patients with cancer
      located in the chest area receiving radiation therapy to the thorax with or without
      chemotherapy. Doxepin hydrochloride is a tricyclic antidepressant drug which was recently
      shown to be helpful for mouth pain in patients receiving radiation therapy. Doxepin
      hydrochloride affects the surface of the esophagus, which may be helpful in reducing the pain
      caused by radiation therapy.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To provide baseline data regarding the effectiveness of doxepin (doxepin hydrochloride) in
      reducing esophagitis-related pain in patients undergoing radiation therapy (RT) to the
      thorax, as measured by a patient-reported questionnaire at 5 minutes, 15 minutes, 30 minutes,
      1 hour and then at 2 and 4 hours on day 1.

      SECONDARY OBJECTIVES:

      I. To assess the adverse event profile of doxepin swish and swallow using a patient-reported
      questionnaire at 5 minutes, 15 minutes, 30 minutes, 1 hour and then at 2 and 4 hours using
      Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group
      (RTOG) acute toxicity criteria, and also for domains of unpleasant taste, burning/stinging
      discomfort, and drowsiness.

      II. To evaluate the effectiveness of doxepin in reducing esophagitis-related pain in patients
      undergoing RT to the thorax, as measured by a patient-reported questionnaire at 5 minutes, 15
      minutes, 30 minutes, 1 hours and then at 2 and 4 hours on days 1 and 3 (including the
      cross-over phase).

      III. To compare and provide baseline data regarding alternative analgesic use between the
      doxepin and placebo arms.

      IV. To provide baseline data regarding the patients? preference for continued therapy with
      doxepin or placebo after initial test dose or after the cross-over phase, as measured by
      items 9 and 10 in the patient-reported questionnaire at 4 hours after administration of the
      study medication and the actual participation rate.

      TERTIARY OBJECTIVES:

      I. To assess pain reduction and other adverse event profile in the optional continuation
      phase of doxepin oral rinse therapy. (Only applies to patients who have the optional
      continuation of doxepin oral rinse after the first two phases)

      OUTLINE: Patients are randomized to 1 of 2 treatment groups.

      GROUP I: Patients receive doxepin hydrochloride oral solution (swish, gargle for 30 seconds,
      and slowly swallow) on day 1. Patients then crossover to Arm II on day 3.

      GROUP II: Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly
      swallow) on day 1. Patients then crossover to Arm I on day 3.

      In both arms, patients may continue to receive doxepin hydrochloride oral solution every 4
      hours as needed during radiation therapy.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment

Secondary Outcome

 Incidence of Any Grade 3 or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE)

Condition

Esophageal Carcinoma

Intervention

Doxepin Hydrochloride

Study Arms / Comparison Groups

 Group I (doxepin hydrochloride)
Description:  Patients receive doxepin hydrochloride oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1. Patients then crossover to Arm II on day 3.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

5

Start Date

April 14, 2014

Completion Date

November 6, 2017

Primary Completion Date

May 29, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Histological confirmation of thoracic malignancies including non-small cell lung
             cancer (NSCLC), small lung cancer (SCLC), esophageal cancer, hypopharyngeal and
             laryngeal cancers (for which esophagitis symptoms can be relieved by doxepin swallow),
             lymphoma, thyroid, thymoma, thymic carcinoma, mesothelioma, sarcoma, and spinal,
             pulmonary or pleural-based metastases

          -  Planned RT (with or without chemotherapy) to a dose of >= 20 Gray (Gy) using 1.60 Gy
             per daily fraction; if radiation is given twice daily, a cumulative planned dose of >=
             15 Gy using at least 1.25 Gy per fraction is required; hypofractionated and
             stereotactic body radiation therapy regimen are allowed

          -  At least 5 cm of the esophagus must be planned to receive radiotherapy, with a minimum
             dose of at least 10 Gy

          -  >= 3 esophageal pain, either at rest or during swallowing, felt to be related to
             esophagitis for which the patient wants relief, as measured by asking the following
             question

               -  ?On a scale of 0 to 10 (0 = no pain; 10 = worst pain), what number best describes
                  your chest pain* (right now) due to your radiation treatment??

                    -  Radiation can cause inflammation in your esophagus which can feel like a
                       chest pain, either at rest or during swallowing

          -  Able to swallow the study medication

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

          -  Negative pregnancy test done =< 28 days prior to registration, for women of
             childbearing potential only

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Provide informed written consent

          -  Willingness to complete evaluation and questionnaires per protocol at the
             participating institution for follow-up (during the active monitoring phase of the
             study)

        Exclusion Criteria:

          -  Known allergy to doxepin, tricyclic antidepressants, or any known component of the
             drug formulation

          -  Histologic proof of and getting treatment for esophageal, stomach, spinal cord,
             thyroid, breast, and head and neck cancers and vertebral metastases

          -  Use of a tricyclic antidepressant or monoamine oxidase inhibitor within the 2 weeks
             prior to registration

          -  The presence or strong clinical suspicion of a tracheoesophageal fistula, or known
             esophageal invasion by cancer

          -  Current untreated or unresolved esophageal candidiasis or herpes simplex virus (HSV)
             infection

          -  Current untreated narrow angle glaucoma

          -  Current untreated urinary retention =< 6 weeks prior to registration

          -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
             of the investigator, 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

          -  Any of the following

               -  Pregnant women

               -  Nursing women

          -  Current use of doxepin or doxepin rinse as a swallow preparation
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Terence Sio, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02062632

Organization ID

MC13C1

Secondary IDs

NCI-2014-00253

Responsible Party

Sponsor

Study Sponsor

Mayo Clinic

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Terence Sio, Principal Investigator, Mayo Clinic


Verification Date

November 2018