ClinicalTrials.Veeva

Menu

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

Alliance for Clinical Trials in Oncology logo

Alliance for Clinical Trials in Oncology

Status and phase

Completed
Phase 3

Conditions

Breast Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug/Agent Toxicity by Tissue/Organ

Treatments

Other: placebo
Drug: urea/lactic acid-based topical cream
Dietary Supplement: pyridoxine hydrochloride

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00296036
NCCTG-N05C5
ROCHE-NCCTG-N05C5
NCI-2009-00655 (Registry Identifier)
CDR0000464246 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome.

PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer.

Full description

OBJECTIVES:

  • Determine whether the prophylactic use of a topical urea/lactic acid cream can decrease the incidence/severity of capecitabine-caused palmar-plantar erythrodysesthesia in patients receiving capecitabine for breast and/or other cancer.
  • Evaluate the potential toxicity of this cream.
  • Determine whether the prophylactic use of vitamin B6 can decrease the incidence and/or severity of capecitabine-caused palmar-plantar erythrodysesthesia.
  • Evaluate the potential toxicity of vitamin B6.
  • Determine whether the prophylactic use of a topical urea/lactic acid cream in combination with vitamin B6 can decrease the incidence and/or severity of capecitabine caused palmar-plantar erythrodysesthesia.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (< 50 years old vs 50-60 years old vs > 60 years old), sex, capecitabine dose level (2000 mg/day vs 2500 mg/day), cancer type (breast vs other), and mode of therapy (adjuvant [including neo-adjuvant] therapy vs metastatic disease). Patients are randomized to 1 of 6 treatment arms (treatment arms I-IV closed to accrual as of 10/24/007).

  • Arm I (closed to accrual as of 10/24/2007): Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
  • Arm II (closed to accrual as of 10/24/2007): Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
  • Arm III (closed to accrual as of 10/24/2007): Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
  • Arm IV (closed to accrual as of 10/24/2007):Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
  • Arm V: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
  • Arm VI: Patients receive placebo cream applied to palms and soles twice daily on days 1-21.

In all arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Enrollment

137 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast and/or other cancer

  • Undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy OR for metastatic disease

    • Receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) OR 2,500 mg/day for 14 days with 4 courses of therapy at 3 week (+/- 3 days) intervals
  • Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

  • Male or female
  • Menopausal status not specified
  • No history of allergy to urea-containing cream
  • No pre-existing neuropathy ≥ grade 2
  • No other dermatologic condition, that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment

PRIOR CONCURRENT THERAPY:

  • No other concurrent agents that function to prevent palmar-plantar erythrodysesthesia caused by capecitabine or topical agents in the hands or feet for other indications (e.g., dryness)

  • No concurrent vitamin B6 > 50 mg/day

  • No concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following:

    • Aqua Care®
    • Medicated Calamine^® lotion (0.3%)
    • Coppertone^® Waterproof Ultra Protection Sunblock
    • Dr. Scholl's^® Smooth Touch deep moisturizing cream
    • Depicure^® So Smooth Cream
    • Dove^® Moisturizing Cream Wash
    • Cetaphil^ ®Moisturizing Cream
    • Vaseline Intensive Care ^ ® lotion

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

137 participants in 6 patient groups, including a placebo group

Arm I (closed to accrual as of 10/24/2007)
Experimental group
Description:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
Treatment:
Dietary Supplement: pyridoxine hydrochloride
Drug: urea/lactic acid-based topical cream
Arm II (closed to accrual as of 10/24/2007)
Experimental group
Description:
Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
Treatment:
Drug: urea/lactic acid-based topical cream
Other: placebo
Arm III (closed to accrual as of 10/24/2007)
Experimental group
Description:
Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
Treatment:
Dietary Supplement: pyridoxine hydrochloride
Other: placebo
Arm IV (closed to accrual as of 10/24/2007)
Placebo Comparator group
Description:
Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
Treatment:
Other: placebo
Arm V
Experimental group
Description:
Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
Treatment:
Drug: urea/lactic acid-based topical cream
Arm VI
Placebo Comparator group
Description:
Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
Treatment:
Other: placebo

Trial contacts and locations

231

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems