Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy (OralAcu)

Universität Duisburg-Essen

Status: Enrolling

Conditions: Chemotherapy; Acupuncture; Dysgeusia; Cancer; Taste Disorders

Treatments: Behavioral: Dietary recommendations; Other: Hypoglossal acupuncture; Other: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02304913

14-5953-BO

Details and patient eligibility

About

This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.

Full description

Taste disorders are frequent side effects in patients undergoing chemotherapy (CTX). Dysguesia has prevalence rates of 16% to 1000% during CTX with sometimes also persistent courses. Impact of dysguesia on appetite, body weight as well as health-related quality of life was shown. Until now, evidence for adequate treatment options is limited to specific diary recommendations. Acupuncture in the treatment of side effects of chemotherapy was investigated for nausea and xerostomia, but not for dysguesia. Therefore, this randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Initial treatment with platinum-containing or taxane-based CTX (regardless of the the length of the CTX cycle)
• Senological, gynecological or internistic tumors
• Phantogeusia (on average ≥4 NRS)
• Willingness to participate in the study and written informed consent

Exclusion criteria

• Severe stomatitis
• Dysgeusia before the CTX based on neurological diseases, diabetes, or the ingestion of drugs with taste disorders as side effects
• Leucopenia/neutropenia
• Intake of anticoagulants
• Smoking
• Severe physical or mental comorbidity (due to which the patient is unable to participate in the study)
• Participation in other CAM treatments within the integrative oncology care
• Participation in other studies on the effectiveness of interventions for oral complications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Hypoglossal acupuncture

Experimental group

Description:

Single treatment of hypoglossal needle acupuncture during the chemotherapy administration: Treated points will be Jinjin (Golden Liquid/EX-HN12) left beside the lingual frenulum and Yuye (Jade Fluid/EX-HN13) right beside the lingual frenulum. Both points are treated in quick succession with immediate removal of the needle.

Treatment:

Other: Hypoglossal acupuncture

Sham acupuncture

Sham Comparator group

Description:

Single treatment of hypoglossal sham acupuncture uring the chemotherapy administration: Treated points will be 1 to 1.5 cun (a cun is defined as the width of the patient's thumb at the knuckle) beside the verum acupuncture points Jinjin and Yuye using the dull side of the needle.

Treatment:

Other: Sham acupuncture

Dietary recommendations

Active Comparator group

Description:

This group adheres to specific dietary recommendations for dysgeusia of the German Cancer Society.

Treatment:

Behavioral: Dietary recommendations