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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01874860
First received: June 6, 2013
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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 Intervention 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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Incidence of Rash [ Time Frame: Change from Baseline, week 3, week 8 ] [ Designated as safety issue: Yes ]
    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:
  • Quality of Life (QOL) [ Time Frame: Change from Baseline, week 3, week 8 ] [ Designated as safety issue: No ]
    Estimate and compare the quality of life (QOL) between the extensive treatment group and standard treatment group.

  • Adherence to treatment regimen [ Time Frame: Change in adherence from baseline to week 8 ] [ Designated as safety issue: Yes ]
    Estimate and compare adherence rate in Extensive Treatment Group and Standard Treatment Group

  • Progression Free Survival [ Time Frame: Surival Follow up (6 months, 12 months, 18 months, and 24 months) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874860

Contacts
Contact: Rebecca A. Redman, MD 502-562-4370 raredm01@louisville.edu
Contact: Karen R. Ellis, BSN 502-562-4370 krelli03@louisville.edu

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Clinical Trials Office    502-562-3429    bcccto@louisville.edu   
Sub-Investigator: Lauren S. Sledjeski, Pharm.D.         
Sub-Investigator: Mika R. Kessans, Pharm.D.         
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Rebecca A. Redman, MD James Graham Brown Cancer Center
  More Information

No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01874860     History of Changes
Other Study ID Numbers: BCC-OHN-GI-13
Study First Received: June 6, 2013
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Head and Neck Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone-17-butyrate
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Cortisol succinate
Cortisone
Doxycycline
Hydrocortisone
Hydrocortisone acetate
Sunscreening Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 23, 2014