Menadione Topical Lotion in Treating Skin Discomfort and Psychological Distress in Patients With Cancer Receiving Panitumumab, Erlotinib Hydrochloride, or Cetuximab

NCT01393821 | Completed Results DMC

• 4 other identifiers: MC10C9NCI-2011-0104711-001566R21CA134432
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial studies menadione topical lotion in treating skin discomfort and psychological distress in patients with cancer receiving panitumumab, erlotinib hydrochloride, or cetuximab. Menadione topical lotion may prevent rash or other skin discomfort and help alleviate psychological distress and pain in patients receiving treatment with panitumumab, erlotinib hydrochloride, or cetuximab

Conditions

Dermatologic Complications; Malignant Neoplasm; Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort

  Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question ("How would you describe how your face feels?") with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning.

  From Baseline to Week 4

Secondary Outcomes (3)

• The Number of Patients Experiencing Worst Toxicity

  Up to 8 weeks

• Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)

  Baseline, 4 weeks

• Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)

  Baseline, Week 4

Study Arms (2)

Arm I (lotion)

EXPERIMENTAL

Patients apply menadione topical lotion BID for 28 days.

Drug: menadione topical lotion; Other: questionnaire administration; Procedure: management of therapy complications

Arm II (placebo)

PLACEBO COMPARATOR

Patients apply topical placebo lotion BID for 28 days.

Other: placebo; Other: questionnaire administration

Interventions

menadione topical lotion DRUG

Given topically

Arm I (lotion)

placebo OTHER

Given topically

Also known as: PLCB

Arm II (placebo)

questionnaire administration OTHER

Ancillary studies

Arm I (lotion); Arm II (placebo)

management of therapy complications PROCEDURE

Given menadione topical lotion

Also known as: complications of therapy, management of

Arm I (lotion)

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient has already started the epidermal growth factor receptor inhibitor but has not been on it for longer than 3 days and has no signs or symptoms potentially suggestive of EGFR inhibitor toxicity.
• Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for women of childbearing potential only.
• Willing to have photographs taken to assess rash.

You may not qualify if:

• Any active facial and/or chest rash, including adult acne, at the time of randomization.
• Cutaneous metastases, skin cancer, or a history of precancerous skin lesions involving the face and/or chest.
• Use of topical corticosteroids on the face and/or chest at the time of study entry or their anticipated use in the next 8 weeks.
• Any type of ongoing therapy for rash.
• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
• Use of any antibiotic at the time of study or their anticipated use in the 8 weeks immediately following study enrollment.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic Campus in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Aminah Jatoi, M.D.
• Organization: Mayo Clinic

Jatoi.Aminah@mayo.edu

(507) 284-7202

Study Officials

• Aminah Jatoi, M.D.

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 13, 2011
• Study Start: January 23, 2012
• Primary Completion: May 11, 2013
• Study Completion: July 14, 2018
• Last Updated: May 16, 2025
• Results First Posted: October 16, 2019

Record last verified: 2025-05

Locations

US (2)