Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
Condition: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions
Intervention: pyridoxine hydrochloride; urea/lactic acid-based topical cream; placebo
Intervention description: Given orally; Applied topically; Given orally or applied topically
Intervention MeSH terms: Pyridoxine; Vitamin B 6
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: drug/agent toxicity by tissue/organ; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; unspecified adult solid tumor, protocol specific

Summary:

      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.
    

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