Clinical trial NCT04554732: Keratinocyte Growth Factor- Hair Serum for the Prevention of Chemotherapy Induced Alopecia
Official title: A Study to Investigate Keratinocyte Growth Factor- Hair Serum for the Prevention of Chemotherapy Induced Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alopecia
Chemotherapy-Induced Change
Hair Loss
Alopecia Drugs
Keywords: Chemotherapy-induced hair loss
Keratinocyte Growth Factor
KGF
Hair loss
Alopecia
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 28
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary aim is to provide a preliminary assessment of the efficacy of the investigational topical formula, KGF-HS, as a prophylactic treatment for chemotherapy induced alopecia.

Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. The investigators will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale.

Detailed description: Primary specific aims

1. To provide a preliminary assessment of the efficacy of the investigational topical formula, KGF-HS, as a prophylactic treatment for chemotherapy induced alopecia.

   Hypothesis: KGF-HS will result in less than 50% hair loss by the end of 4 cycles of chemotherapy. The investigators will evaluate hair loss using the CTCAE (Common Terminology Criteria for Adverse Events) v4.0 alopecia grading scale.

   Secondary specific aims
2. To estimate hair preservation as assessed by participant and physician.
3. To estimate participant reported comfort.
4. To evaluate quality of life.
5. To evaluate the incidence of adverse events for topical application.
6. To evaluate if topical hair serum results in faster hair growth after completion of chemotherapy in those who had grade 2 or higher alopecia while on chemotherapy
7. To evaluate responses to chemotherapy at time of surgery (for patients undergoing neoadjuvant chemotherapy (NAC))

Study Design: This study is a 2-part trial. For part 1 of the study, subjects will be enrolled into a prospective single arm phase where all of them get the study treatment. Investigators plan to enroll up to 25 subjects to have 20 evaluable subjects to this phase. At the end of 4 cycles of chemotherapy, primary efficacy end point data will be collected. After 20 evaluable subjects if ≥ 4 responses were noted, part 2 of the study will be activated. The decision rule is based on the lower bound of a one-sided 95% confidence interval; at least 4 out of 20 patients with response results in a lower bound greater than 5% success. The proportion with success and the lower bound of a one-sided exact confidence interval will be computed.

Part 2 of the study is a randomized double blind-placebo controlled trial. Investigators plan to randomize 40 subjects 1:1 to this portion. This sample size was selected to provide 82% statistical power to detect an improvement from a 5% response rate in the control arm to a 35% response rate in the treated arm (assuming a one-sided alpha level of 0.05). Primary efficacy end point will be assessed by clinicians who will be independent and unaware of the study treatment. Participant withdrawals from the study will be deemed treatment failures. Secondary efficacy end points are success in hair preservation assessed by participant's clinician and by the participant, use of wigs and/or head wraps; participant-reported comfort; and quality of life (QOL). Comparison of the proportions between the treated and control arms will be performed using a chi-square test; the confidence interval for the difference between the proportions will be estimated. Comparison of differences in mean quality of life scores will be performed using two sample independent t tests. Adverse events will be reported by grade and tabulated. In phase 1 part of the study, the number of patients undergoing NAC and responses at time of surgery will be noted. No formal statistics will be done. In phase 2 part of the study, proportion of patients undergoing neoadjuvant chemotherapy and their responses at time of surgery will be recorded and comparisons will be done by chi-square test. Investigators do not anticipate the study serum to influence response to chemotherapy as there is no significant systemic absorption however since KGF is a cytoprotective agent, investigators will collect data on response to chemotherapy (for patients undergoing neoadjuvant treatment only).

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with early stage breast cancer (stage I-III)
2. Scheduled but not begun, at least 4 cycles of taxane and/or anthracycline-based chemotherapy
3. ≥ 21 years of age
4. Able to give informed consent

Exclusion Criteria:

1. Female pattern hair loss or hair loss disorder
2. Scalp folliculitis
3. Scalp psoriasis
4. Seborrheic dermatitis
5. Inflammatory scalp conditions such as lichen plano-pillaris
6. Subjects wearing wigs or subjects who shave their hair prior to chemotherapy
7. Unable to provide consent or make allotted clinical visits
8. Known allergy to KGF-HS being use in this study

Primary outcomes:
measure: Part 1: Preliminary assessment of the efficacy of the investigational topical formula, KGF-HS measuring hair loss after chemotherapy.
timeFrame: Four months
measure: Part 2: Randomized, placebo-controlled assessment of the efficacy of the investigational topical formula, KGF-HS measuring hair loss after chemotherapy.
timeFrame: Four months
Secondary outcomes:
measure: Hair preservation as assessed by participant.
timeFrame: Four months
measure: Hair preservation as assessed by physician.
timeFrame: Four months
measure: Estimate participant reported comfort.
timeFrame: Four months
measure: Evaluate quality of life using EORTC QLQ-C30
timeFrame: Four months
measure: Evaluate quality of life using HADS.
timeFrame: Four months
measure: Evaluate quality of life using BIS.
timeFrame: Four months
measure: Evaluate the incidence of adverse events for topical application.
timeFrame: Four months
measure: Evaluate hair regrowth.
timeFrame: Four months
measure: Evaluate responses to chemotherapy at time of surgery.
timeFrame: Four months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Pavani Chalasani, MD
role: PRINCIPAL_INVESTIGATOR
References: