Zinc Sulfate in Preventing Loss of Sense of Taste in Patients Undergoing Radiation Therapy for Head and Neck Cancer

NCT00036881 | Completed Phase 3 DMC

• 4 other identifiers: NCCTG-N01C4NCI-2012-02465NCI-P02-0224CDR0000069337
• Study Type: interventional
• Target: 173
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: It is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer.

Conditions

Dysgeusia; Head and Neck Cancer; Oral Complications; Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

• Prolongation of the time to onset of altered taste by zinc sulfate

  Up to 1.5 years

Secondary Outcomes (1)

• Incidence of taste alteration

  Up to 1.5 years

Study Arms (2)

zinc sulfate

EXPERIMENTAL

Patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy. Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity. Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment. Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.

Dietary Supplement: zinc sulfate

placebo

PLACEBO COMPARATOR

Patients receive oral placebo 3 times daily beginning the first week of radiotherapy. Treatment continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity. Quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment. Patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.

Other: placebo

Interventions

zinc sulfate DIETARY_SUPPLEMENT

zinc sulfate

placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of head and neck cancer * No stage I laryngeal cancer * Planned treatment with at least 2,000 cGy of external beam radiotherapy to at least 30% of the oral cavity PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Gastrointestinal: * Able to tolerate oral medication * No known mechanical obstruction of the alimentary tract * No malabsorption * No intractable vomiting (more than 5 episodes per week) Other: * No known intolerance to zinc sulfate * No known, untreated oral thrush * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Surgery: * No prior surgery that included ablation or removal of the olfactory component of taste Other: * No concurrent zinc supplements * Concurrent standard multivitamins allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22. doi: 10.1016/j.ijrobp.2006.10.046.

  PMID: 17394940 RESULT

MeSH Terms

Conditions

Dysgeusia; Head and Neck Neoplasms; Radiation Injuries

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Aminah Jatoi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 14, 2016

Record last verified: 2016-07