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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01393821
• Collaborator: (none)
• Enrollment: 27
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 132
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dermatologic Complications; Malignant Neoplasm; Pain	Drug: menadione topical lotion; Other: placebo; Other: questionnaire administration; Procedure: management of therapy complications	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. Explore the effectiveness of a menadione topical lotion to the face to prevent cutaneous and psychological discomfort from epidermal growth factor receptor (EGFR) inhibitors.

SECONDARY OBJECTIVES:

1. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors.

2. Explore whether rash or adverse events worsen over a 4 week period after this 4-week intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients apply menadione topical lotion twice daily (BID) for 28 days.

ARM II: Patients apply topical placebo lotion BID for 28 days.

After completion of study treatment, patients are followed up for 4 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: May 11, 2013
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I (lotion) Patients apply menadione topical lotion BID for 28 days.	Drug: menadione topical lotion; Given topically; Other: questionnaire administration; Ancillary studies; Procedure: management of therapy complications; Given menadione topical lotion; Other Names: complications of therapy, management of
Placebo Comparator: Arm II (placebo) Patients apply topical placebo lotion BID for 28 days.	Other: placebo; Given topically; Other Names: PLCB ; Other: questionnaire administration; Ancillary studies

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort [From Baseline to Week 4]

   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.

Secondary Outcome Measures

1. The Number of Patients Experiencing Worst Toxicity [Up to 8 weeks]

   The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm.

2. Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand) [Baseline, 4 weeks]

   Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. 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.

3. Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand) [Baseline, Week 4]

   Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Campus in Arizona	Phoenix	Arizona	United States	85054
2	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Study Chair: Aminah Jatoi, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01393821
• Other Study ID Numbers: MC10C9; NCI-2011-01047
• First Posted: Jul 13, 2011
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Neoplasms

Study Results

Participant Flow

Arm/Group Title	Arm A (Menadione)	Arm B (Placebo)
Arm/Group Description	Patients apply menadione topical lotion BID for 28 days.	Patients apply topical placebo lotion BID for 28 days.
Period Title: Overall Study
STARTED	14	13
COMPLETED	9	10
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Arm A (Menadione)	Arm B (Placebo)	Total
Arm/Group Description	Patients apply menadione topical lotion BID for 28 days.	Patients apply topical placebo lotion BID for 28 days.	Total of all reporting groups
Overall Participants	13	12	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (9.3)	64.3 (12.6)	63.4 (10.8)
Sex: Female, Male (Count of Participants)
Female	6 46.2%	6 50%	12 48%
Male	7 53.8%	6 50%	13 52%
Region of Enrollment (Count of Participants)
United States	13 100%	12 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort
Description	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.
Time Frame	From Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Patients who completed the face pain question at baseline and week 4 are included in this analysis.

Arm/Group Title	Arm A (Menadione)	Arm B (Placebo)
Arm/Group Description	Patients apply menadione topical lotion BID for 28 days.	Patients apply topical placebo lotion BID for 28 days.
Measure Participants	8	10
Median (Inter-Quartile Range) [score on a scale]	2.0	3.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A (Menadione), Arm B (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6311
	Comments
	Method	Kruskal-Wallis
	Comments

2. Secondary Outcome

Title	The Number of Patients Experiencing Worst Toxicity
Description	The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm.
Time Frame	Up to 8 weeks

Outcome Measure Data

Analysis Population Description

Excludes cancel patients who never received treatment.

Arm/Group Title	Arm A (Menadione)	Arm B (Placebo)
Arm/Group Description	Patients apply menadione topical lotion BID for 28 days.	Patients apply topical placebo lotion BID for 28 days.
Measure Participants	13	12
Grade 1	3 23.1%	3 25%
Grade 2	7 53.8%	6 50%
Grade 3	3 23.1%	3 25%

3. Secondary Outcome

Title	Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)
Description	Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. 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.
Time Frame	Baseline, 4 weeks

Outcome Measure Data

Analysis Population Description

Excludes cancel patients who never received treatment.

Arm/Group Title	Arm A (Menadione)	Arm B (Placebo)
Arm/Group Description	Patients apply menadione topical lotion BID for 28 days.	Patients apply topical placebo lotion BID for 28 days.
Measure Participants	13	12
Least Squares Mean (Standard Error) [score on a scale]	2.1820 (0.5003)	1.8244 (0.4376)

4. Secondary Outcome

Title	Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)
Description	Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question ("How often have you been bothered by embarrassment about your face?") with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

Excludes cancel patients who never received treatment.

Arm/Group Title	Arm A (Menadione)	Arm B (Placebo)
Arm/Group Description	Patients apply menadione topical lotion BID for 28 days.	Patients apply topical placebo lotion BID for 28 days.
Measure Participants	13	12
Least Squares Mean (Standard Error) [score on a scale]	0.7196 (0.3436)	1.1891 (0.3043)

Adverse Events

Time Frame	Up to 8 weeks
Adverse Event Reporting Description	Excludes cancel patients who never received treatment.
Arm/Group Title	Arm A (Menadione)		Arm B (Placebo)
Arm/Group Description	Patients apply menadione topical lotion BID for 28 days.		Patients apply topical placebo lotion BID for 28 days.
All Cause Mortality
	Arm A (Menadione)		Arm B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)		0/13 (0%)
Serious Adverse Events
	Arm A (Menadione)		Arm B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)		1/13 (7.7%)
Gastrointestinal disorders
Diarrhea	1/12 (8.3%)	1	0/13 (0%)	0
Nausea	1/12 (8.3%)	1	0/13 (0%)	0
Vomiting	1/12 (8.3%)	1	0/13 (0%)	0
Nervous system disorders
Stroke	1/12 (8.3%)	1	0/13 (0%)	0
Skin and subcutaneous tissue disorders
Pain of skin	0/12 (0%)	0	1/13 (7.7%)	1
Pruritus	0/12 (0%)	0	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	Arm A (Menadione)		Arm B (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/12 (91.7%)		13/13 (100%)
Ear and labyrinth disorders
Ear pain	0/12 (0%)	0	1/13 (7.7%)	1
Gastrointestinal disorders
Mucositis oral	1/12 (8.3%)	2	1/13 (7.7%)	1
General disorders
Facial pain	1/12 (8.3%)	1	0/13 (0%)	0
Fatigue	0/12 (0%)	0	1/13 (7.7%)	1
Pain	0/12 (0%)	0	1/13 (7.7%)	1
Metabolism and nutrition disorders
Dehydration	1/12 (8.3%)	1	1/13 (7.7%)	1
Skin and subcutaneous tissue disorders
Dry skin	0/12 (0%)	0	1/13 (7.7%)	1
Erythema multiforme	1/12 (8.3%)	1	1/13 (7.7%)	1
Pain of skin	0/12 (0%)	0	3/13 (23.1%)	3
Pruritus	5/12 (41.7%)	6	9/13 (69.2%)	11
Rash maculo-papular	10/12 (83.3%)	16	12/13 (92.3%)	16
Skin and subcutaneous tissue disorders - Other, specify	1/12 (8.3%)	1	0/13 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.