The Effect of Physiotherapy Program in Patients Undergoing Chemotherapy in Patients With Colon Cancer

NCT ID: NCT06476522

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-05-01

Brief Summary

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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

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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

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Colon Cancer Chemotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention Group and Control Group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

The exercises were taught to the patients in the intervention group practically by the physiotherapist so that they could do their exercises at home.

Group Type EXPERIMENTAL

Physiotherapy Program

Intervention Type OTHER

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 Inform

Intervention Type OTHER

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.

Control

The control group patients continued with their routine chemotherapy treatment determined by their doctor. No intervention was made other than routine treatments.

Group Type ACTIVE_COMPARATOR

To Inform

Intervention Type OTHER

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.

Interventions

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Physiotherapy Program

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.

Intervention Type OTHER

To Inform

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \> 18 years of age,
* diagnosed with stage 2-3 colon cancer
* scheduled to receive adjuvant chemotherapy
* able to read, write and understand Turkish.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atılım University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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İlke KESER, Assoc. Prof.

Role: STUDY_DIRECTOR

Gazi University

Locations

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Gazi University

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AU-BENGUBOZ-001

Identifier Type: -

Identifier Source: org_study_id

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