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

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.

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.

Eligibility 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