Acupuncture for Dysphagia in Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05143268

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2023-10-30

Brief Summary

This is a randomized phase 2 study on the impact of acupuncture on acute dysphagia in patients treated with radio-chemotherapy for head and neck squamous cell carcinoma

Detailed Description

In order to attempt to reduce the impact of adverse effects produced by oncological treatments, cancer patients frequently turn to complementary integrative therapies.

Among them, acupuncture has been characterized by a growing role in cancer-related symptoms management in last 10 years.

After FDA approval for use as a medical device in 1996, the application of this technique in oncology has been on the rise in the Western countries.

By modulating brain regions involved in cognition and emotion, some degree of successful symptom management with acupuncture has been demonstrated in oncology In the context of head and neck cancer, the first application of acupuncture was related to chronic shoulder pain and dysfunction following neck dissection.

The primary objective of the study is to compare the effect of acupuncture and standard treatment on swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory) 2 weeks after the end of RT (end of treatment, EoT).

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

A

In the experimental arm (arm A), a total of 11 sessions of acupuncture will be performed on a weekly basis, spanning from 2 weeks before Radiotherapy start throughout 7 weeks of treatment, to 2 weeks after its completion. Patients randomized to the experimental arm will receive acupuncture in addition to standard of care treatment, chosen by the treating multidisciplinary team in accordance with international guidelines.

No interventions assigned to this group

B

In the standard arm (arm B), patients will be treated with standard of care treatment.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• histologically-confirmed diagnosis of squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx and larynx or histologically-confirmed diagnosis of undifferentiated carcinoma of the nasopharynx
• by judgement of the local investigator, indication for a DNST with curative intent, consisting of one of the 3 following options:

• radiotherapy alone
• cisplatin-based concomitant chemo-radiotherapy
• cetuximab-based concomitant bio-radiotherapy
• clinical stage of disease: II, III, IVA, IVB (according to TNM/AJCC 8th edition) for primary tumors of the larynx, hypopharynx and oropharynx (p16/HPV negative), provided that for stage II disease (cT2N0) the local investigator will prescribe an elective irradiation of regional lymph nodes
• clinical stage of disease: I, II, III (according to TNM/AJCC 8th edition) for primary tumors of the oropharynx (p16/HPV positive), provided that for stage I disease (cT1N0) the local investigator will prescribe an elective irradiation of regional lymph nodes

• metastatic disease
• gross total excision of both primary and nodal disease before index treatment
• surgical manipulation including therapeutic tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
• prior radiotherapy to the head and neck region
• induction chemotherapy prior to radiotherapy
• prior use of acupuncture for SCCHN or for different indications
• prior allergic reaction or history of hypersensitivity to inox austenitic steel (Cr18Ni9)
• active or prior documented neurologic or rheumatologic disorder with a potential impact on the swallowing function (i.e: multiple sclerosis, amyotrophic lateral sclerosis, scleroderma)
• active process of severe skin infection in the neck contraindicating the execution of acupuncture in the opinion of the investigator
• severe baseline dysphagia documented by a MDADI scale (MD Anderson Dysphagia Inventory) composite score below 60
• any condition that, in the opinion of the investigator, would not require to encompass at least ipsilateral neck lymph nodes in the irradiation field
• any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lorenzo Livi

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo Livi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

AOU Careggi Radiation Oncology Unit

Florence, , Italy

Site Status: RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lorenzo Livi, Professor

Role: CONTACT

lorenzo.livi@unifi.it

0557947192

Facility Contacts

Lorenzo Livi, Prof.

Role: primary

segr-radiotp@dfc.unifi.it

+390557947264

Pierluigi Bonomo

Role: backup

bonomop@aou-careggi.toscana.it

+390557947264

Noela Gori, Study Coordinator

Role: primary

datamanager.ng.rt@sbsc.unifi.it

0557947192

Other Identifiers

ACP-HN

Identifier Type: -

Identifier Source: org_study_id