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

NCT01874860 | Completed Phase 2 DMC

• 1 other identifier: BCC-OHN-GI-13
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Rash

  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).

  Change from Baseline, week 3, week 8

Secondary Outcomes (3)

• Quality of Life (QOL)

  Change from Baseline, week 3, week 8

• Adherence to treatment regimen

  Change in adherence from baseline to week 8

• Progression Free Survival

  Surival Follow up (6 months, 12 months, 18 months, and 24 months)

Study Arms (2)

Extensive treatment group

EXPERIMENTAL

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; Drug: Hydrocortisone 1% cream; Other: Sunscreen; Other: Moisturizer; Drug: Clindamycin; Drug: Medrol-dose pack (Steroid)

Standard care group

EXPERIMENTAL

Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.

Other: Sunscreen; Other: Moisturizer

Interventions

Doxycycline DRUG

Doxycycline capsule, 100 mg, taken twice daily

Extensive treatment group

Hydrocortisone 1% cream DRUG

Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream)

Extensive treatment group

Sunscreen OTHER

Applied to exposed skin areas at least 30 minutes before going outdoors each morning.

Also known as: SPF 30 or higher sunscreen

Extensive treatment group; Standard care group

Moisturizer OTHER

Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen

Also known as: Any frangrance-free moisturizer will do

Extensive treatment group; Standard care group

Clindamycin DRUG

Recommended for daily use if rash returns (Topical cream)

Also known as: Clindamycin 1 % gel

Extensive treatment group

Medrol-dose pack (Steroid) DRUG

Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.

Also known as: Medrol-dose pack

Extensive treatment group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Prior cetuximab treatment within the 6 months of study initiation
• Current treatment with tyrosine kinase inhibitors
• Patients who are pregnant or incarcerated

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Head and Neck Neoplasms

Interventions

Doxycycline; Hydrocortisone; Sunscreening Agents; Clindamycin; Gels; Steroids

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Fused-Ring Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Rebecca A. Redman, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 11, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

US (1)