Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 78 of 10364 for:    strength

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03100175
Recruitment Status : Unknown
Verified March 2017 by IULIANA VAXMAN, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
IULIANA VAXMAN, Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
Strength Aerobic Training Elderly Lymphoma Sarcopenia Aging Behavioral: physiotherapy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Strength and Aerobic Training in Elderly Lymphoma Patients During Chemotherapy and Its Impact on Treatment Outcomes, Patients Functioning and Biological Markers of Ageing
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: intervention

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

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



Primary Outcome Measures :
  1. treatment tolerance [ Time Frame: 6 month ]
    treatment dose density

  2. muscle strength and mass [ Time Frame: 6 month ]
    evaluated by physiotherapists

  3. elements activities of daily living [ Time Frame: 6 month ]
    evaluated by physiotherapists

  4. DNA methylation [ Time Frame: 6 month ]
    blood tests

  5. INK 4a expression [ Time Frame: 6 month ]
    blood test

  6. telomere length [ Time Frame: 6 month ]
    blood tests

  7. serum levels of inteleukin 6 [ Time Frame: 6 month ]
    blood tests

  8. CRP [ Time Frame: 6 month ]
    blood tests



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 70 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

Exclusion Criteria:

  • no

Layout table for additonal information
Responsible Party: IULIANA VAXMAN, principal investigator, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03100175     History of Changes
Other Study ID Numbers: 113-17
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no paln to share data, study will be done in our center only

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Sarcopenia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms