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Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01874860
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : December 1, 2022
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Rebecca Redman, University of Louisville

Study Description
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Brief Summary:
The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Head and Neck Cancer Drug: Doxycycline Drug: Hydrocortisone 1% cream Other: Sunscreen Other: Moisturizer Drug: Clindamycin Drug: Medrol-dose pack (Steroid) Phase 2

Detailed Description:

Of the 100 subjects who will participate in this study, 50 will be in the extensive treatment group and 50 will be in the standard care group. Subjects in the extensive treatment group will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or higher, moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and chest each evening.

Subjects will start taking the capsule and applying the creams three days prior to beginning cetuximab therapy. They will continue this regimen of taking the capsule and applying the creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the study doctor may decide to reduce the amount of the dose of cetuximab that they receive or prescribe other medicines according to standard treatment recommendations, just as he/she would if the subject was not participating in this study. Subjects will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.

The standard care group will not receive preventive treatment, but they will be allowed to use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side effects and quality of life.

If a subject is assigned to this group and they develop a severe skin rash, the study doctor will treat their rash according to standard treatment recommendations, which may include Hydrocortisone 1% cream, Doxycycline capsules or other medications.

There will be a follow-Up period for both extensive treatment and standard care groups. At 6 months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study treatment period, they will be contacted by telephone or discussed during their routine clinic visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients
Actual Study Start Date : August 2013
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Extensive treatment group

Doxycycline capsule, 100 mg, taken twice daily; sunscreen SPF 30 or higher applied to exposed skin areas at least 30 minutes before going outdoors each morning; moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen; Hydrocortisone 1% topical cream applied to the face, hands, feet, neck, back, and chest each evening.

For patients with grade 1 rash, hydrocortisone 1% cream and clindamycin 1% gel (tetracycline antibiotic) are recommended for daily use.

For patients with grade 2 rash, hydrocortisone cream and doxycycline 100mg twice daily or minocycline (tetracycline antibiotic) 100mg once daily is recommended.

For patients with grade 3 rash, systemic steroid therapy (a Medrol dose-pack) will be added to the grade 2 treatment.

 Drug: Doxycycline
Doxycycline capsule, 100 mg, taken twice daily

Drug: Hydrocortisone 1% cream
Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream)

Other: Sunscreen
Applied to exposed skin areas at least 30 minutes before going outdoors each morning.
Other Name: SPF 30 or higher sunscreen

Other: Moisturizer
Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen
Other Name: Any frangrance-free moisturizer will do

Drug: Clindamycin
Recommended for daily use if rash returns (Topical cream)
Other Name: Clindamycin 1 % gel

Drug: Medrol-dose pack (Steroid)
Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.
Other Name: Medrol-dose pack
Experimental: Standard care group
Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.
 Other: Sunscreen
Applied to exposed skin areas at least 30 minutes before going outdoors each morning.
Other Name: SPF 30 or higher sunscreen

Other: Moisturizer
Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen
Other Name: Any frangrance-free moisturizer will do


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Rash [ Time Frame: Change from Baseline, week 3, week 8 ]
    Evaluate the incidence of cetuximab-induced rash, Compare the severity of cetuximab-induced rash between the extensive treatment group (ETG) and the standard care group (SCG).


Secondary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: Change from Baseline, week 3, week 8 ]
    Estimate and compare the quality of life (QOL) between the extensive treatment group and standard treatment group.

  2. Adherence to treatment regimen [ Time Frame: Change in adherence from baseline to week 8 ]
    Estimate and compare adherence rate in Extensive Treatment Group and Standard Treatment Group

  3. Progression Free Survival [ Time Frame: Surival Follow up (6 months, 12 months, 18 months, and 24 months) ]
    Estimate and compare Progression-Free Survival (PFS) in extensive treatment group and standard treatment group. Survival follow-ups will be at 6 months, 12 months, 18 months, and 24 months post treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 18 years
  2. Diagnosis of colorectal or head and neck cancer
  3. Receipt of at least one dose of cetuximab during the study time period

Exclusion Criteria:

  1. Prior cetuximab treatment within the 6 months of study initiation
  2. Current treatment with tyrosine kinase inhibitors
  3. Patients who are pregnant or incarcerated
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874860


Locations
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United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
James Graham Brown Cancer Center
Investigators
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Principal Investigator: Rebecca A. Redman, MD James Graham Brown Cancer Center
More Information
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Responsible Party: Rebecca Redman, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01874860    
Other Study ID Numbers: BCC-OHN-GI-13
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Exanthema
Neoplasms by Site
Neoplasms
Skin Diseases
Doxycycline
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Hydrocortisone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
 Sunscreening Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids