Head and Neck Squamous Cell CarcinomaACP-HNNCT05143268
Acupuncture for Dysphagia in Head and Neck Squamous Cell Carcinoma
An observational study of Head and Neck Squamous Cell Carcinoma, run by Lorenzo Livi at 2 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- How many people
- 90 participants
- Where
- 2 sitesItaly
- Study dates
- 3 Jun 2021to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over 18 years old who have received a histologically-confirmed diagnosis of squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx and larynx or histologically-confirmed diagnosis of undifferentiated carcinoma of the nasopharynx
Who may be able to join
- 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
Who cannot join
- histologically-confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with HNSCC of unknown primary or non-squamous histologies
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
AOU Careggi Radiation Oncology Unit
Florence, 50134
Lorenzo Livi, Prof., +390557947264, segr-radiotp@dfc.unifi.it
Pierluigi Bonomo, +390557947264, bonomop@aou-careggi.toscana.it
- Recruiting
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Noela Gori, Study Coordinator, 0557947192, datamanager.ng.rt@sbsc.unifi.it
About this study
Official title: Impact of Acupuncture on Acute Dysphagia in Patients Treated With Radio-chemotherapy for Head and Neck Squamous Cell Carcinoma: a Randomized Phase 2 Study
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
Read the 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
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| B | In the standard arm (arm B), patients will be treated with standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)
Measured: two weeks after the end of treatment
Secondary outcomes (9)
Secondary objective n.1
Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)
Measured: 12 weeks after end of treatment
Secondary objective n.2
Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)
Measured: 24 weeks after end of treatment
Secondary objective n.3
Patients' quality of life assessed with the EORTC QLQ-C30 and QLC-HN 43
Measured: 12 and 24 weeks after end of treatment
Secondary objective n.4
Feasibility of acupuncture (percentage of completed acupuncture sessions out of planned per protocol)
Measured: maximum of 11 weekly sessions
Secondary objective n.5
Incidence of moderate-severe dysphagia (>G2) assessed with CTCAE v. 5.0
Measured: 2 weeks after end of treatment
Secondary objective n.6
Incidence of moderate-severe adverse events (G3-G4) assessed with CTCAE v.5
Measured: 2 weeks after end of treatment
Secondary objective n.7
Relative dose intensity of systemic therapy
Measured: 2 weeks after the end of treatment
Secondary objective n.8
Radiation interruptions
Measured: 2 weeks after end of treatment
Secondary objective n.9
Relative weight loss (percentage of weight loss compared with baseline value at start of therapy)
Measured: 2 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start3 Jun 2021
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lorenzo Livi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143268
- Sponsor's protocol ID
- ACP-HN
- Acronym
- ACP-HN
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acupuncture on Acute Dysphagia in Patients Treated With Radio-chemotherapy for Head and Neck Squamous Cell Carcinoma: a Randomized Phase 2 Study
- ClinicalTrials.gov ID
- NCT05143268
- Acronym / sponsor ID
- ACP-HN / ACP-HN
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Lorenzo LiviUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| B | – | –In the standard arm (arm B), patients will be treated with standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 18 years old who have received a histologically-confirmed diagnosis of squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx and larynx or histologically-confirmed diagnosis of undifferentiated carcinoma of the nasopharynx
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- histologically-confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with HNSCC of unknown primary or non-squamous histologies
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary objective
Time frame: two weeks after the end of treatment
Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)
9 secondary outcomes
Secondary objective n.1
Time frame: 12 weeks after end of treatment
Secondary objective n.2
Time frame: 24 weeks after end of treatment
Secondary objective n.3
Time frame: 12 and 24 weeks after end of treatment
Secondary objective n.4
Time frame: maximum of 11 weekly sessions
Secondary objective n.5
Time frame: 2 weeks after end of treatment
Secondary objective n.6
Time frame: 2 weeks after end of treatment
Secondary objective n.7
Time frame: 2 weeks after the end of treatment
Secondary objective n.8
Time frame: 2 weeks after end of treatment
Secondary objective n.9
Time frame: 2 weeks after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma, run by Lorenzo Livi at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Livi, Professor (0557947192, lorenzo.livi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: two weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.