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

• ClinicalTrials.gov Identifier: NCT01874860
• Recruitment Status: Completed
• First Posted: June 11, 2013
• Last Update Posted: December 1, 2022
• Sponsor: University of Louisville
• Collaborator: James Graham Brown Cancer Center
• Information provided by (Responsible Party): Rebecca Redman, University of Louisville

Tracking Information

• First Submitted Date: June 6, 2013
• First Posted Date: June 11, 2013
• Last Update Posted Date: December 1, 2022
• Actual Study Start Date: August 2013
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2013)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 10, 2013)

• 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.
• 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
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients
• 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
• 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.

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Colorectal Cancer
• Head and Neck Cancer

Intervention

• 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

Study Arms

• 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.

  Interventions:

  • Drug: Doxycycline
  • Drug: Hydrocortisone 1% cream
  • Other: Sunscreen
  • Other: Moisturizer
  • Drug: Clindamycin
  • Drug: Medrol-dose pack (Steroid)
• Experimental: Standard care group
  Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.
  Interventions:

  • Other: Sunscreen
  • Other: Moisturizer

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 29, 2022): 24
• Original Estimated Enrollment (submitted: June 10, 2013): 100
• Actual Study Completion Date: July 2018
• Actual Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01874860
• Other Study ID Numbers: BCC-OHN-GI-13
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rebecca Redman, University of Louisville
• Original Responsible Party: James Graham Brown Cancer Center
• Current Study Sponsor: University of Louisville
• Original Study Sponsor: James Graham Brown Cancer Center
• Collaborators: James Graham Brown Cancer Center

Investigators

• Principal Investigator: Rebecca A. Redman, MD; James Graham Brown Cancer Center

• PRS Account: University of Louisville
• Verification Date: November 2022