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A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients with Head and Neck Cancer

Status
Active
Cancer Type
Head and Neck Cancer
Oral Cancer
Trial Phase
Phase III
Eligibility
Not specified, Male and Female
Study Type
Supportive care
NCD ID
NCT01141231
Protocol IDs
97115 (primary)
NCI-2011-02073
CDR0000674208
WF 97115
WFU-97115
MDA-04-01
Study Sponsor
Wake Forest NCORP Research Base

Summary

TRIAL STATUS: Active

This randomized phase III trial studies acupuncture to see how well it works compared to sham acupuncture or standard therapy in treating dry mouth caused by radiation therapy (xerostomia) in patients with head and neck cancer. Acupuncture may help relieve dry mouth caused by radiation therapy.

Objectives

PRIMARY OBJECTIVES:

I. To determine whether or not acupuncture can symptomatically improve moderate or severe xerostomia (grade 2 or 3) due to head/neck radiotherapy.

SECONDARY OBJECTIVES:

I. To explore the duration of response (up to a maximum of 6 months) in the subgroup of patients who report a response to the acupuncture intervention.

II. Examine group differences in saliva flow using unstimulated and stimulated whole salivary flow rates.

III. Examine whether true acupuncture results in better overall quality of life (QOL) than sham acupuncture or standard of care.

IV. Determine the effects of acupuncture on saliva-based factors including pH, buffering capacity, and viscosity as well as levels of total protein, calcitonin-gene related peptide, and vasoactive intestinal polypeptide.

V. Examine the role of expectancy for the benefits of acupuncture in predicting outcomes. The role of expectancy as a moderator of the effects of treatment will be thoroughly examined.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive standard oral hygiene care for 8 weeks, including instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice.

ARM II: Patients receive acupuncture at 3 sites on each ear, on the chin, on each forearm, on each hand, on each leg, and a placebo needle above the right knee for 20 minutes twice a week for 4 weeks. Patients with minor response may continue treatment for an additional 4 weeks. Patients also receive standard oral hygiene as in Arm I.

ARM III: Patients receive sham acupuncture twice a week for 4 weeks and standard oral hygiene as in Arm I. Patients with minor response may continue treatment for an additional 4 weeks.

After completion of study treatment, patients are followed up at 6 or 7.5 months.

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