Colon CancerNCT06476522
The Effect of Physiotherapy Program in Patients Undergoing Chemotherapy in Patients With Colon Cancer
A study testing Physiotherapy Program and To Inform in people with Colon Cancer and Chemotherapy Effect, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Studies examining the effect of exercise on the side effects of chemotherapy in colon and rectal cancer have found strong evidence for short-term improvements. The aim of this study was to investigate the effect of 12weeks home based physiotherapy program on toxicity, muscle strength, balance, and endurance in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Chemotherapy Effect
- What is being tested?
- Physiotherapy Program and To Inform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2019to 1 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age,
- diagnosed with stage 2-3 colon cancer
- scheduled to receive adjuvant chemotherapy
- able to read, write and understand Turkish.
Who cannot join
- cardiopulmonary disease, nerve, muscle, or joint disease, affecting movement
- malignant tumors
- postoperative heart, cerebral vessel, or other mental
- illness or serious cognitive impairment and defects in language serious complications
- < 18 kg Body Mess Index
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physiotherapy Program on Toxicity, Muscle Strength, Balance, and Endurance in Patients Undergoing Chemotherapy in Patients With Colon Cancer
Aim: Studies examining the effect of exercise on the side effects of chemotherapy in colon and rectal cancer have found strong evidence for short-term improvements. The aim of this study was to investigate the effect of 12weeks home based physiotherapy program on toxicity, muscle strength, balance, and endurance in patients undergoing chemotherapy in patients with CC.
Method: Patients diagnosed with colon cancer (CC) were invited to participate in the study before the start of adjuvant chemotherapy. All patients participating in the study were given general information about the chemotherapy period, possible chemotherapy-related side effects, and coping strategies. The patients were categorized into two groups as control an intervention. Intervention Group were taught and shown the exercises, walking activity, balance and sensory training exercises practically by the physiotherapist. Exercises were performed as home exercises during the 12 weeks. Demographic information and clinical information were recorded. The side effects of toxicity like fatigue, nausea, vomiting, and oral wounds were evaluated with The National Cancer Institute-Common Terminology Criteria for Adverse Events. Iliopsoas, Quadriceps, Gastrosoleus, and Tibialis Anterior muscles strength were evaluated by Manual Muscle Testing. The standing balance was assessed with The one-leg-stance (OLS) timed test. The lower extremity muscle strength and endurance was tested with The 30-sec Chair Stand Test. Sensory evaluations were made with the Semmes Weinstein Monofilament Test and the two-point discrimination test.
Read the detailed description
Background:
Colon cancer (CC) is the third most diagnosed type of cancer worldwide. The age of onset varies between 50-75 years . Control of risk factors and early detection and its precursors through screening have an important role in reducing the incidence and mortality of CC. This means that the number of people living with and undergoing treatment for CC is growing.
One of the common treatment of CC is chemotherapy. It is known that chemotherapy can cause severe adverse effects that can be highly detrimental to a patient both physiologically and psychologically, thus having a large impact on an individual's quality of life (QoL). The most common and severe of these adverse effects are peripheral neuropathy, neutropenia, nausea, vomiting, diarrhea, and fatigue . In addition, liver and kidney dysfunctions are seen in patients undergoing chemotherapy. Depending on the chemotherapy-related toxicity, side effects such as neutropenia, thrombocytopenia, and anemia occur in patients. For this reason, regular blood tests of the patients during the chemotherapy process and their blood values were followed.
Studies examining the effect of exercise on the side effects of chemotherapy in colon and rectal cancer have found strong evidence for short-term improvements. There are various studies investigating the effects of exercises performed during chemotherapy on QoL, fatigue, and aerobic capacity in patients with CC. However, the duration and content of exercise programs in these studies are quite limited. No study was examined the effects of a home-based physiotherapy and recommendation program during 12-weeks chemotherapy treatment. The aim of this study was to investigate the effect of physiotherapy program on toxicity, muscle strength, balance, and endurance in patients undergoing chemotherapy in patients with CC.
- Conditions
- Colon Cancer, Chemotherapy Effect
- Being tested
- Physiotherapy Program, To Inform
- Keywords
- Exercise, Toxicity, Muscle Strength, Balance, Endurance
- Medical subject headings
- Colonic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy ProgramOther
In the first evaluation, 5 different exercises were shown and the patients were asked to do home exercises in accordance with the given program. The physiotherapist suggested starting with a 10-minute walk 5 times a week and then gradually increasing the walking time. The patients were given a program for balance and sensory training. They were asked to apply the physiotherapy program at least 3 days a week for 12 weeks. Weekly follow-up of the patients was carried out by the physiotherapist over the phone or face to face when they underwent routine treatment.
To InformOther
The patients were informed that they would be evaluated by the physiotherapist when they came to the routine doctor's control in the first week and at the end of the 12 weeks. At the end of 12 weeks, these patients were also given home-based exercise program advice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The exercises were taught to the patients in the intervention group practically by the physiotherapist so that they could do their exercises at home. Receives: Other: Physiotherapy Program; Other: To Inform |
| Control | Active comparator | The control group patients continued with their routine chemotherapy treatment determined by their doctor. No intervention was made other than routine treatments. Receives: Other: To Inform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Iliopsoas, Quadriceps, Gastrosoleus, and Tibialis Anterior muscles strength were evaluated by Manual Muscle Testing. For muscle tests; Dr. Robert W. Lovett explained the muscle strength test method, starting with a value of 3. The 3+, 4, 4+ and 5 values of the muscle that can perform the 3 value were checked. If it cannot reach the value of 3, the values of 2, 1, and 0 were checked.
Measured: change from baseline at 12 weeks
Secondary outcomes (5)
Chemotherapy Toxicity
The side effects of toxicity like fatigue, nausea, vomiting, and oral wounds were evaluated with The National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE v5.0, http://ctep.cancer.gov). A rating scale is given for each negative side effect term. Clinical severity ratings for side effects are rated from grades 1-5.
Measured: change from baseline at 12 weeks
Balance
The standing balance was assessed with The one-leg-stance (OLS) timed test. The participants were instructed to stand on their dominant leg with their eyes closed.
Measured: change from baseline at 12 weeks
Endurance
The lower extremity muscle strength and endurance was tested with The 30-sec Chair Stand Test.
Measured: change from baseline at 12 weeks
Sensory 1
It was evaluated with the Semmes Weinstein Monofilament Test (SWM). Evaluation was made in designated areas of the hands and feet.
Measured: change from baseline at 12 weeks
Sensory 2
Two-point discrimination sense was evaluated with an esthesiometer. Evaluation was made in designated areas of the hands and feet.
Measured: change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Oct 2019
- Primary completion1 Dec 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group and Control Group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İlke KESER, Assoc. Prof., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476522
- Sponsor's protocol ID
- AU-BENGUBOZ-001
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2024
- Last updated
- 26 Jun 2024
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiotherapy Program on Toxicity, Muscle Strength, Balance, and Endurance in Patients Undergoing Chemotherapy in Patients With Colon Cancer
- ClinicalTrials.gov ID
- NCT06476522
- Acronym / sponsor ID
- AU-BENGUBOZ-001
- Conditions
- Colon Cancer, Chemotherapy Effect
- Keywords
- Exercise, Toxicity, Muscle Strength, Balance, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 26 Jun 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.
Aim: Studies examining the effect of exercise on the side effects of chemotherapy in colon and rectal cancer have found strong evidence for short-term improvements. The aim of this study was to investigate the effect of 12weeks home based physiotherapy program on toxicity, muscle strength, balance, and endurance in patients undergoing chemotherapy in patients with CC.
Method: Patients diagnosed with colon cancer (CC) were invited to participate in the study before the start of adjuvant chemotherapy. All patients participating in the study were given general information about the chemotherapy period, possible chemotherapy-related side effects, and coping strategies. The patients were categorized into two groups as control an intervention. Intervention Group were taught and shown the exercises, walking activity, balance and sensory training exercises practically by the physiotherapist. Exercises were performed as home exercises during the 12 weeks. Demographic information and clinical information were recorded. The side effects of toxicity like fatigue, nausea, vomiting, and oral wounds were evaluated with The National Cancer Institute-Common Terminology Criteria for Adverse Events. Iliopsoas, Quadriceps, Gastrosoleus, and Tibialis Anterior muscles strength were evaluated by Manual Muscle Testing. The standing balance was assessed with The one-leg-stance (OLS) timed test. The lower extremity muscle strength and endurance was tested with The 30-sec Chair Stand Test. Sensory evaluations were made with the Semmes Weinstein Monofilament Test and the two-point discrimination test.
Detailed description
Background:
Colon cancer (CC) is the third most diagnosed type of cancer worldwide. The age of onset varies between 50-75 years . Control of risk factors and early detection and its precursors through screening have an important role in reducing the incidence and mortality of CC. This means that the number of people living with and undergoing treatment for CC is growing.
One of the common treatment of CC is chemotherapy. It is known that chemotherapy can cause severe adverse effects that can be highly detrimental to a patient both physiologically and psychologically, thus having a large impact on an individual's quality of life (QoL). The most common and severe of these adverse effects are peripheral neuropathy, neutropenia, nausea, vomiting, diarrhea, and fatigue . In addition, liver and kidney dysfunctions are seen in patients undergoing chemotherapy. Depending on the chemotherapy-related toxicity, side effects such as neutropenia, thrombocytopenia, and anemia occur in patients. For this reason, regular blood tests of the patients during the chemotherapy process and their blood values were followed.
Studies examining the effect of exercise on the side effects of chemotherapy in colon and rectal cancer have found strong evidence for short-term improvements. There are various studies investigating the effects of exercises performed during chemotherapy on QoL, fatigue, and aerobic capacity in patients with CC. However, the duration and content of exercise programs in these studies are quite limited. No study was examined the effects of a home-based physiotherapy and recommendation program during 12-weeks chemotherapy treatment. The aim of this study was to investigate the effect of physiotherapy program on toxicity, muscle strength, balance, and endurance in patients undergoing chemotherapy in patients with CC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Group and Control Group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physiotherapy Program, Other: To InformThe exercises were taught to the patients in the intervention group practically by the physiotherapist so that they could do their exercises at home. |
| Control | Active comparator | Other: To InformThe control group patients continued with their routine chemotherapy treatment determined by their doctor. No intervention was made other than routine treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years of age,
- diagnosed with stage 2-3 colon cancer
- scheduled to receive adjuvant chemotherapy
- able to read, write and understand Turkish.
Key exclusion criteria (5 listed)
- cardiopulmonary disease, nerve, muscle, or joint disease, affecting movement
- malignant tumors
- postoperative heart, cerebral vessel, or other mental
- illness or serious cognitive impairment and defects in language serious complications
- < 18 kg Body Mess Index
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 |
|---|---|---|
| Physiotherapy ProgramIn the first evaluation, 5 different exercises were shown and the patients were asked to do home exercises in accordance with the given program. The physiotherapist suggested starting with a 10-minute walk 5 times a week and then gradually increasing the walking time. The patients were given a program for balance and sensory training. They were asked to apply the physiotherapy program at least 3 days a week for 12 weeks. Weekly follow-up of the patients was carried out by the physiotherapist over the phone or face to face when they underwent routine treatment. | Other | Intervention |
| To InformThe patients were informed that they would be evaluated by the physiotherapist when they came to the routine doctor's control in the first week and at the end of the 12 weeks. At the end of 12 weeks, these patients were also given home-based exercise program advice. | Other | Control, Intervention |
Primary outcome
Muscle strength
Time frame: change from baseline at 12 weeks
Iliopsoas, Quadriceps, Gastrosoleus, and Tibialis Anterior muscles strength were evaluated by Manual Muscle Testing. For muscle tests; Dr. Robert W. Lovett explained the muscle strength test method, starting with a value of 3. The 3+, 4, 4+ and 5 values of the muscle that can perform the 3 value were checked. If it cannot reach the value of 3, the values of 2, 1, and 0 were checked.
5 secondary outcomes
Chemotherapy Toxicity
Time frame: change from baseline at 12 weeks
Balance
Time frame: change from baseline at 12 weeks
Endurance
Time frame: change from baseline at 12 weeks
Sensory 1
Time frame: change from baseline at 12 weeks
Sensory 2
Time frame: change from baseline at 12 weeks
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 26 Jun 2024.
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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.
İlke KESER, Assoc. Prof. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Program and To Inform in people with Colon Cancer and Chemotherapy Effect, run by Atılım University at 1 site in Turkey (Türkiye).
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 5 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 26 Jun 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 Turkey (Türkiye). 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?
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?
Muscle strength (time frame: change from baseline at 12 weeks). 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 26 Jun 2024.