Strength and Aerobic Training in Elderly Lymphoma Patients During Chemotherapy and Its Impact on Treatment Outcomes, Patients Functioning and Biological Markers of Aging

NCT03100175 | Unknown

• 1 other identifier: 113-17
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Frailty, one of geriatric syndromes, is considered a major obstacle for recovery from physiological stress. Such stress is imposed on patients with cancer by virtue of the disease itself but even more so by the treatment. Moreover, malignancy and chemotherapy both cause accelerated loss of muscle mass, deconditioning, frailty and negative outcomes. Several studies showed that chemotherapy accelerates ageing. Muscle mass reserve was found to be a major predictor of outcomes in patients treated with chemotherapy. Recently, several studies suggest that active muscle strength training during chemotherapy may decrease side effects, improves the ability to deliver intended doses of treatment and may even affect oncological outcomes. In the proposed study we intend to assess the contribution of physical training to the well-being of chemotherapy treated older patients, assessed by molecular and physiological parameters. We intend to recruit lymphoma patients above age of 70 and prospectively and randomly assign them to the intervention group (strength, aerobic and balance training during the chemotherapy) and control group (standard care with no special emphasis on physical activity during the treatment). We will measure clinical outcomes such as treatment tolerance and effects as well as physiological outcomes (muscle strength and mass, elements activities of daily living) and laboratory markers of ageing such as DNA methylation, INK 4a expression, telomere length and serum levels of inteleukin 6, CRP among others. Our hypothesis is that physical training will improve patients' ability to complete the treatment with fewer side effects, will provide them with better daily functioning and better muscle strength/function. We also hypothesize that the ageing process, as shown by laboratory senescence markers, will be attenuated in the intervention group.

Conditions

Strength Aerobic Training Elderly Lymphoma Sarcopenia Aging

Outcome Measures

Primary Outcomes (8)

• treatment tolerance

  treatment dose density

  6 month

• muscle strength and mass

  evaluated by physiotherapists

  6 month

• elements activities of daily living

  evaluated by physiotherapists

  6 month

• DNA methylation

  blood tests

  6 month

• INK 4a expression

  blood test

  6 month

• telomere length

  blood tests

  6 month

• serum levels of inteleukin 6

  blood tests

  6 month

• CRP

  blood tests

  6 month

Study Arms (2)

intervention

EXPERIMENTAL

the patient will be scheduled for another appointment and taught a set of exercises including strength training for upper and lower limbs (with elastic bands and weights, rising up from chair and climbing stairs), fitness work out (brisk walking) and balance exercises, as recommended by senior sport programs. * Patients will be provided with printed instructions explaining the recommended exercises, and with a diary to fill in, with days and number of repetitions of specific training elements to be checked in according to their compliance. Patients will also be equipped with a pedometer and will be asked to record the counts regularly * Patients will be met again by a physiotherapist for follow up at the start of every chemotherapy course (once in 3-4 weeks) and will be contacted by phone twice weekly to assure they stick to the training recommendations

Behavioral: physiotherapy

control

NO INTERVENTION

The control group will receive standard treatment and follow-up with no special emphasis on physical activity

Interventions

physiotherapy BEHAVIORAL

strength training for upper and lower limbs fitness and balance work out

intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years old and older
• Newly diagnosed large B cell lymphoma, Hodgkin lymphoma or follicular lymphoma planned for at least 75% of full dose chemotherapy
• preserved cognition or mild dementia
• Ability to perform physical activity

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: April 4, 2017
• Study Start: May 1, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share