Colorectal Cancer Patients and Their PartnersNCT06725043
Ultrasound Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
A study testing Therapeutic ultrasound and Traditional physical therapy program in people with Colorectal Cancer Patients and Their Partners and Oxaliplatin-induced Peripheral Neuropathy, run by Cairo University at 1 site in Egypt.
Trial summary
The current study was conducted to examine the effect of ultrasound acupuncture for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Colorectal Cancer Patients and Their Partners, Oxaliplatin-induced Peripheral Neuropathy
- What is being tested?
- Therapeutic ultrasound and Traditional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 3 Dec 2024
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- The subject selection was according to the following criteria:
- Adults their ages ranged from 20 to 70 years old.
- Receiving or have received chemotherapy treatment for colon or rectal cancer.
- Chemotherapy regimen included the agent oxaliplatin.
- Patients diagnosed with neuropathy by the oncologist.
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- Both sexes.
- No neuropathy prior to oxaliplatin treatment.
- No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis)
- Stage II, III and IV colon or rectal cancer.
- Hands and Feets were the most affected by CIPN.
- The first dose of oxaliplatin was from 4 months or more.
Who cannot join
- The potential participants were excluded in the following conditions:
- Another malignancy
- Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
- Participants who cannot remain on the same medications throughout the study period with minor dose adjustments allowed.
- Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet (representing severe CIPN), metal or plastic implantation
- Peripheral vascular disease in hands or feet.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Suez Canal University
Ismailia, Ismalia, 41616
About this study
The current study was conducted to examine the effect of ultrasound acupuncture for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.
Read the detailed description
Oxaliplatin is platinum-based chemotherapy most usually used for the treatment of metastatic colorectal cancer, this drug can produce a cumulative and dose-limiting distal sensory neuropathy affecting the majority of oxaliplatin-treated patients. Despite intense investigation at the preclinical and clinical levels, no treatment can be suggested for the prevention of OIPN. Since acupuncture has proven effective in alleviating the severity of peripheral nerve neuropathy, as has ultrasound.
This systematic review was conducted to test the ability of ultrasound acupuncture in decreasing neuropathy-related symptoms induced by oxaliplatin-based chemotherapies in colorectal cancer patients
- Being tested
- Therapeutic ultrasound, Placebo therapeutic ultrasound, Traditional physical therapy program
- Keywords
- oxaliplatin, peripheral neuropathy, ultrasound acupuncture
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ultrasoundDevice
Pulsed therapeutic ultrasound (1 MHz , 50% duty cycle and intensity gradually increased till the patient felt a deqi sensation).Each point was stimulated by ultrasound for 5 minutes at bilateral acupuncture points of PC6, PC7, BL60 and KI1(3 times / week for 4 weeks).
Placebo therapeutic ultrasoundDevice
patients were received placebo therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI.
Traditional physical therapy programOther
Strengthing exercise, balance training, stretching exercises and home exercise program and education
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Therapeutic ultrasound (1 MHz) Pulsed mode at bilateral acupuncture points of PC6, PC7, BL60 andKI1 Receives: Device: Therapeutic ultrasound; Other: Traditional physical therapy program |
| Experime | Placebo comparator | Placebo Therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI1 Receives: Device: Placebo therapeutic ultrasound; Other: Traditional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level assessment
In comfortable siting position we asked them to give each item from the 10-items score from 0 to 10 according to the intensity of the symptom, 0 means that the symptom is absent and 10 means maximum intensity. Sum of scores is 100, a higher score is associated with increased pain
Measured: 2.5 months
Assessment of pain pressure threshold
Pain pressure threshold at hand and foot was measured by using a digital pressure algometer with a probe of 1 cm2 .PPT at feets was measured on the plantar foot surface over the second metatarsal. PPT at hands was measured on thenar eminence of the hand
Measured: 2.5 months
Secondary outcomes (1)
National Cancer Institute Common Toxicity Criteria
NCI CTC are set of medical terms very useful for the classification of adverse events related to cytotoxic drugs. These terms are not international codes for reporting adverse events to the Health Authorities. They are very frequently used in handling adverse events from oncology trials
Measured: 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jul 2023
- Primary completion30 Aug 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Patients and Their PartnersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Ali Mahmoud Ibrahim Badr Al-din, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725043
- Sponsor's protocol ID
- Ultrasound Acupuncture for OIP
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT06725043
- Acronym / sponsor ID
- Ultrasound Acupuncture for OIP
- Keywords
- oxaliplatin, peripheral neuropathy, ultrasound acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 10 Dec 2024 (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.
The current study was conducted to examine the effect of ultrasound acupuncture for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients.
Detailed description
Oxaliplatin is platinum-based chemotherapy most usually used for the treatment of metastatic colorectal cancer, this drug can produce a cumulative and dose-limiting distal sensory neuropathy affecting the majority of oxaliplatin-treated patients. Despite intense investigation at the preclinical and clinical levels, no treatment can be suggested for the prevention of OIPN. Since acupuncture has proven effective in alleviating the severity of peripheral nerve neuropathy, as has ultrasound.
This systematic review was conducted to test the ability of ultrasound acupuncture in decreasing neuropathy-related symptoms induced by oxaliplatin-based chemotherapies in colorectal cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Therapeutic ultrasound, Other: Traditional physical therapy programTherapeutic ultrasound (1 MHz) Pulsed mode at bilateral acupuncture points of PC6, PC7, BL60 andKI1 |
| Experime | Placebo comparator | Device: Placebo therapeutic ultrasound, Other: Traditional physical therapy programPlacebo Therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI1 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- Adults their ages ranged from 20 to 70 years old.
- Receiving or have received chemotherapy treatment for colon or rectal cancer.
- Chemotherapy regimen included the agent oxaliplatin.
- Patients diagnosed with neuropathy by the oncologist.
Key exclusion criteria (6 listed)
- The potential participants were excluded in the following conditions:
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 |
|---|---|---|
| Therapeutic ultrasoundPulsed therapeutic ultrasound (1 MHz , 50% duty cycle and intensity gradually increased till the patient felt a deqi sensation).Each point was stimulated by ultrasound for 5 minutes at bilateral acupuncture points of PC6, PC7, BL60 and KI1(3 times / week for 4 weeks). | Device | Active |
| Placebo therapeutic ultrasoundpatients were received placebo therapeutic ultrasound at bilateral acupuncture points of PC6, PC7, BL60, and KI. | Device | Experime |
| Traditional physical therapy programStrengthing exercise, balance training, stretching exercises and home exercise program and education | Other | Active, Experime |
Primary outcome
Pain level assessment
Time frame: 2.5 months
In comfortable siting position we asked them to give each item from the 10-items score from 0 to 10 according to the intensity of the symptom, 0 means that the symptom is absent and 10 means maximum intensity. Sum of scores is 100, a higher score is associated with increased pain
Assessment of pain pressure threshold
Time frame: 2.5 months
Pain pressure threshold at hand and foot was measured by using a digital pressure algometer with a probe of 1 cm2 .PPT at feets was measured on the plantar foot surface over the second metatarsal. PPT at hands was measured on thenar eminence of the hand
1 secondary outcome
National Cancer Institute Common Toxicity Criteria
Time frame: 2.5 months
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 10 Dec 2024.
- Individual participant dataSharing planned: Yes
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 study testing Therapeutic ultrasound and Traditional physical therapy program in people with Colorectal Cancer Patients and Their Partners and Oxaliplatin-induced Peripheral Neuropathy, run by Cairo University at 1 site in Egypt.
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 12 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 10 Dec 2024. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
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?
Pain level assessment (time frame: 2.5 months). The study lists 2 primary outcomes in all. 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 Dec 2024.