Low Anterior Resection SyndromePhase 1AcuLARSNCT03916549
Acupuncture in Low Anterior Resection Syndrome Treatment
A Phase 1 study testing Acupuncture in people with Low Anterior Resection Syndrome, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
Trial summary
Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Nov 2018to 31 Dec 2019
- Phase
- Phase 1
- 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
Who may be able to join
- patients over 18 year
- signed written consent
- patients experiencing major low anterior resection syndrome
- patients at least one year following the surgery
Who cannot join
- allergy to stainless steal
- implanted pacemaker
- current skin infection
- needle phobia
- metastatic disease to the central nervous system (brain, spinal cord)
- at the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment - Pilot Study
Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome.
Read the detailed description
Colorectal cancer is common in Western countries. For thirty years rectal cancer treatment is standardized: patients are undergoing low anterior resection with mesorectal excision +/- (chemo)radiotherapy. Unfortunately around 80% of patients undergoing low anterior resection will experience complex bowel dysfunction including fecal incontinence, soiling, urgency, incomplete evacuation, fragmented defecation and impaired rectal sensation known as low anterior resection syndrome (LARS) causing a "toilet dependence" which severely affects quality of life.
Still there is no standardized treatment for LARS.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Acupuncture
- Medical subject headings
- Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
The acupuncture procedure is performed by one well trained person, 1 time per week in total of 10 weeks on the same day time. Sterile, disposable, stainless steel acupuncture needles (40x0.25 mm diameter) were inserted to corporal acupoints, with initial gentle stimulation by quick rotation of 1080°, after then leaving needle in located place for twenty minutes. Needling deep - 0.5-1 cm. If the intent was to invigorate - the needle was inserted to the flow of energy; if harmonization needed - the needle was placed perpendicular to the point flow of energy; if sedation was needed, needles were placed against to the flow of energy on channel. The selection of acupoints was based according by traditional Chinese medicine, literature findings.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The patients with bowel dysfunction following low anterior resection performed at least 1 year ago will undergo acupuncture. The acupuncture procedure is performed by one well trained person, 1 time per week in total of 10 weeks on the same day time. Sterile, disposable, stainless steel acupuncture needles (40x0.25 mm diameter) were inserted to corporal acupoints, with initial gentle stimulation by quick rotation of 1080°, after then leaving needle in located place for twenty minutes. Needling deep - 0.5-1 cm. If the intent was to invigorate - the needle was inserted to the flow of energy; if harmonization needed - the needle was placed perpendicular to the point flow of energy; if sedation was needed, needles were placed against to the flow of energy on channel. The selection of acupoints was based according by traditional Chinese medicine, literature findings. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel function changes after the treatment using Low anterior resection syndrome questionnaire
Bowel function assessment using Low anterior resection syndrome questionnaire Bowel function following low anterior resection surgery for rectal cancer will be assessed using Low anterior resection syndrome score (LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Nov 2018
- Primary completion1 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Anterior Resection SyndromeStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of intervention - acupuncture for LARS patients
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916549
- Sponsor's protocol ID
- AcuLARS
- Acronym
- AcuLARS
- Status last verified
- Feb 2022
- First submitted
- 13 Apr 2019
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dulskas A, Aukstikalnis T, Kavaliauskas P, Samalavicius NE. The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment: A Pilot Study. Dis Colon Rectum. 2022 Jan 1;65(1):93-99. doi: 10.1097/DCR.0000000000002060.
PubMed 34882631
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment - Pilot Study
- ClinicalTrials.gov ID
- NCT03916549
- Acronym / sponsor ID
- AcuLARS / AcuLARS
- Conditions
- Low Anterior Resection Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosUniversity, hospital or other
- Collaborators
- Vilnius University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Apr 2019 (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.
Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome.
Detailed description
Colorectal cancer is common in Western countries. For thirty years rectal cancer treatment is standardized: patients are undergoing low anterior resection with mesorectal excision +/- (chemo)radiotherapy. Unfortunately around 80% of patients undergoing low anterior resection will experience complex bowel dysfunction including fecal incontinence, soiling, urgency, incomplete evacuation, fragmented defecation and impaired rectal sensation known as low anterior resection syndrome (LARS) causing a "toilet dependence" which severely affects quality of life.
Still there is no standardized treatment for LARS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of intervention - acupuncture for LARS patients
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: AcupunctureThe patients with bowel dysfunction following low anterior resection performed at least 1 year ago will undergo acupuncture. The acupuncture procedure is performed by one well trained person, 1 time per week in total of 10 weeks on the same day time. Sterile, disposable, stainless steel acupuncture needles (40x0.25 mm diameter) were inserted to corporal acupoints, with initial gentle stimulation by quick rotation of 1080°, after then leaving needle in located place for twenty minutes. Needling deep - 0.5-1 cm. If the intent was to invigorate - the needle was inserted to the flow of energy; if harmonization needed - the needle was placed perpendicular to the point flow of energy; if sedation was needed, needles were placed against to the flow of energy on channel. The selection of acupoints was based according by traditional Chinese medicine, literature findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over 18 year
- signed written consent
- patients experiencing major low anterior resection syndrome
- patients at least one year following the surgery
Key exclusion criteria (6 listed)
- allergy to stainless steal
- implanted pacemaker
- current skin infection
- needle phobia
- metastatic disease to the central nervous system (brain, spinal cord)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe acupuncture procedure is performed by one well trained person, 1 time per week in total of 10 weeks on the same day time. Sterile, disposable, stainless steel acupuncture needles (40x0.25 mm diameter) were inserted to corporal acupoints, with initial gentle stimulation by quick rotation of 1080°, after then leaving needle in located place for twenty minutes. Needling deep - 0.5-1 cm. If the intent was to invigorate - the needle was inserted to the flow of energy; if harmonization needed - the needle was placed perpendicular to the point flow of energy; if sedation was needed, needles were placed against to the flow of energy on channel. The selection of acupoints was based according by traditional Chinese medicine, literature findings. | Device | Group 1 |
Primary outcome
Bowel function changes after the treatment using Low anterior resection syndrome questionnaire
Time frame: 6 months
Bowel function assessment using Low anterior resection syndrome questionnaire Bowel function following low anterior resection surgery for rectal cancer will be assessed using Low anterior resection syndrome score (LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Results publication: PubMed 34882631Dulskas A, Aukstikalnis T, Kavaliauskas P, Samalavicius NE. The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment: A Pilot Study. Dis Colon Rectum. 2022 Jan 1;65(1):93-99. doi: 10.1097/DCR.0000000000002060.
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture in people with Low Anterior Resection Syndrome, run by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos at 1 site in Lithuania.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel function changes after the treatment using Low anterior resection syndrome questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916549, which also lists 1 linked publication.
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 22 Feb 2022.