Clinical trial NCT06476522: The Effect of Physiotherapy Program in Patients Undergoing Chemotherapy in Patients With Colon Cancer
Official title: The Effect of Physiotherapy Program on Toxicity, Muscle Strength, Balance, and Endurance in Patients Undergoing Chemotherapy in Patients With Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Chemotherapy Effect
Keywords: Exercise
Toxicity
Muscle Strength
Balance
Endurance
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group and Control Group
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength
timeFrame: change from baseline at 12 weeks
Secondary outcomes:
measure: Chemotherapy Toxicity
timeFrame: change from baseline at 12 weeks
measure: Balance
timeFrame: change from baseline at 12 weeks
measure: Endurance
timeFrame: change from baseline at 12 weeks
measure: Sensory 1
timeFrame: change from baseline at 12 weeks
measure: Sensory 2
timeFrame: change from baseline at 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
Study officials:
affiliation: Gazi University
name: İlke KESER, Assoc. Prof.
role: STUDY_DIRECTOR
References: