Dermatologic Complications, Malignant Neoplasm, Pain
Conditions
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
Detailed description
PRIMARY OBJECTIVES: I. 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: I. Explore the adverse event profile of a menadione topical lotion to the face to prevent rash from EGFR inhibitors. II. 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.
Interventions
Given topically
OTHERplacebo
Given topically
OTHERquestionnaire administration
Ancillary studies
PROCEDUREmanagement of therapy complications
Given menadione topical lotion
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A (Menadione) Patients apply menadione topical lotion BID for 28 days. | 13 |
| Arm B (Placebo) Patients apply topical placebo lotion BID for 28 days. | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancel | 1 | 1 |
| Overall Study | not evaluable for primary endpoint | 4 | 2 |
Baseline characteristics
| Characteristic | Arm A (Menadione) | Arm B (Placebo) | Total |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 9.3 | 64.3 years STANDARD_DEVIATION 12.6 | 63.4 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 12 | 0 / 13 |
| other Total, other adverse events | 11 / 12 | 13 / 13 |
| serious Total, serious adverse events | 2 / 12 | 1 / 13 |
Outcome results
Primary
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.
Time frame: From Baseline to Week 4
Population: Patients who completed the face pain question at baseline and week 4 are included in this analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A (Menadione) | Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort | 2.0 score on a scale |
| Arm B (Placebo) | Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort | 3.0 score on a scale |
p-value: 0.6311Kruskal-Wallis
Secondary
Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)
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
Population: Excludes cancel patients who never received treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Menadione) | Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand) | 2.1820 score on a scale | Standard Error 0.5003 |
| Arm B (Placebo) | Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand) | 1.8244 score on a scale | Standard Error 0.4376 |
Secondary
Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)
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
Population: Excludes cancel patients who never received treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm A (Menadione) | Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand) | 0.7196 score on a scale | Standard Error 0.3436 |
| Arm B (Placebo) | Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand) | 1.1891 score on a scale | Standard Error 0.3043 |
Secondary
The Number of Patients Experiencing Worst Toxicity
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
Population: Excludes cancel patients who never received treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A (Menadione) | The Number of Patients Experiencing Worst Toxicity | Grade 1 | 3 Participants |
| Arm A (Menadione) | The Number of Patients Experiencing Worst Toxicity | Grade 2 | 7 Participants |
| Arm A (Menadione) | The Number of Patients Experiencing Worst Toxicity | Grade 3 | 3 Participants |
| Arm B (Placebo) | The Number of Patients Experiencing Worst Toxicity | Grade 1 | 3 Participants |
| Arm B (Placebo) | The Number of Patients Experiencing Worst Toxicity | Grade 2 | 6 Participants |
| Arm B (Placebo) | The Number of Patients Experiencing Worst Toxicity | Grade 3 | 3 Participants |