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Physically Active During Cancer Treatment (FAKT) (FAKT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885817
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Alesund Hospital
Levanger Hospital
Ullevaal University Hospital
Sorlandet Hospital HF
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
This randomized controlled trial aims to investigate whether an individually tailored exercise program and nutritional guide can affect the development of self-reported peripheral sensory neuropathy and fatigue in patients with colorectal cancer receiving adjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Neoplasms, Colorectal Behavioral: Exercise training and nutritional guide Other: Standard follow-up care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physically Active During Cancer Treatment
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise training and nutritional guide
Standard recommendations regarding physical activity and nutrition. An individually tailored exercise program and nutritional guide during adjuvant chemotherapy.
Behavioral: Exercise training and nutritional guide
30 minutes of a combination of sensorimotor- and strength training guided by a physical therapist twice a week. In addition 90 minutes a week of moderate intensity aerobic training or 45 minutes a week of high intensity aerobic training. Once a month the participants will fill out the form, PG-SGA SF, and he or she will be referred to a nutritionist if the score is 2 or higher. The intervention period lasts as long as the participants receives adjuvant chemotherapy, i.e. 3 - 6 months.

Other: Standard follow-up care
standard recommendations regarding physical activity and nutrition during the period with adjuvant chemotherapy.

Active Comparator: Standard follow-up care
Standard recommendations regarding physical activity and nutrition.
Other: Standard follow-up care
standard recommendations regarding physical activity and nutrition during the period with adjuvant chemotherapy.




Primary Outcome Measures :
  1. Patient reported peripheral sensory neuropathy [ Time Frame: Baseline to 3 months ]
    The 9-item European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Chemotherapy Induced Peripheral Neuropathy (CIPN20) sensory subscale will be used to measure sensory neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 9 to 36. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: Baseline to 3, 6, 9, 12, 24 and 36 months ]
    Fatigue Questionnaire (FQ) will be used to measure fatigue. FQ contains 13 questions, is generic, and has well-documented psychometric properties. Each question is rated on a scale from 0 ("not at all" or "less than usual") to 3 ("much worse than usual"). FQ measures physical fatigue (PF) (seven questions, scores between 0-21) and mental fatigue (MF) (four questions, scores between 0-12). All questions are combined and constitute total fatigue (TF) (scores between 0-33) Higher scores indicate more fatigue.

  2. Change in patient reported peripheral sensory neuropathy. [ Time Frame: Baseline to 3, 6, 9, 12, 24 and 36 months ]
    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Chemotherapy Induced Peripheral Neuropathy (CIPN20) is a twenty questions quality-of-life questionnaire that has been developed to elicit patients' experience of symptoms and functional limitations related to CIPN (chemotherapy-induced peripheral neuropathy). CIPN20 has 3 sub-scales; a sensory, a motor and an autonomous. The sensory subscale has 9 items where each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 9 to 36. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).

  3. Change in patient reported motor neuropathy [ Time Frame: Baseline to 3, 6, 9, 12, 24 and 36 months ]
    The 8-item European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Chemotherapy Induced Peripheral Neuropathy (CIPN20) motor subscale will be used to measure motor neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 8 to 32. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).

  4. Change in patient reported autonomic neuropathy [ Time Frame: Baseline to 3, 6, 9, 12, 24 and 36 months ]
    The 3-item European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Chemotherapy Induced Peripheral Neuropathy (CIPN20) autonomic subscale will be used to measure autonomic neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 3 to 12. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).

  5. Clinicians reported neuropathy [ Time Frame: Baseline to 3, 6 and 12 months. ]
    Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be used to grade neuropathy using the CTCAE terms Paresthesia (grade 1 -3), Peripheral sensory neuropathy (grade 1 - 4) and Peripheral motor neuropathy (grade 1 - 5). Grading will be performed at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  6. Change in body mass index (BMI) [ Time Frame: Baseline to 3, 6 and 12 months. ]
    Weight and height will be combined to report BMI in kg/m^2. These measures will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  7. Change in systolic blood pressure (sBP) [ Time Frame: Baseline to 3, 6 and 12 months. ]
    sBP is measured in mmHg (millimeter Mercury). This measure will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  8. Change in diastolic blood pressure (dBP) [ Time Frame: Baseline to 3, 6 and 12 months. ]
    dBP is measured in mmHg (millimeter Mercury). This measure will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  9. Change in waist circumference. [ Time Frame: Baseline to 3, 6 and 12 months. ]
    The waist circumference is measured when the patient is standing upright. Locate the midpoint between the lower rib and the top of the iliac crest and mark the point with a marker. Do not use the umbilicus as a measuring point. Place the tape measure on the mark. Ask the patient to hold the tape measure while walking around the patient. Check that the tape measure is horizontal in the middle of the back and that it lies against the body without tightening. Ask the patient to breathe out quietly. Read the circumference to the nearest 0.1 cm. Repeat the measurement and calculate the average.This measure will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  10. Change in HDL-cholesterol [ Time Frame: Baseline to 3, 6 and 12 months. ]
    serum HDL-cholesterol (mmol/L). Blood analysis will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  11. Change in Triglycerides [ Time Frame: Baseline to 3, 6 and 12 months. ]
    serum-triglycerides (mmol/L). Blood analysis will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  12. Change in Glycated hemoglobin (HbA1c) [ Time Frame: Baseline to 3, 6 and 12 months. ]
    Blood HbA1c (mmol/mol). Blood analysis will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  13. Change in Glucose [ Time Frame: Baseline to 3, 6 and 12 months. ]
    serum glucose (mmol/L). Fasting blood analysis will be taken at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  14. Change in Body Composition [ Time Frame: Baseline to 3 and 12 months ]
    A Dexa Scan will be performed to evaluate change in Body Composition

  15. Nutritional status [ Time Frame: Baseline, 1, 2, 3, 4, 5 and 6 months ]
    At baseline and thereafter once a month until completion of adjuvant therapy, nutritional status is evaluated with the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF). This is a validated questionnaire, filled in by the patients to determine malnutrition status. The short form consists of four boxes with different questions. Box 1 is about weight and weight loss, and the score ranges from 0 - 5, where higher score indicates more weight loss. Box 2 is about food intake, and the score range is from 0 - 4, where higher score indicates more difficulties with food intake. Box 3 is about symptoms that have kept one from eating enough past two weeks. The score range is from 0 - 24, where higher score indicates more symptoms. Box 4 is about activities and function, and the score range is from 0 - 3, where higher score indicates a lower functional level.

  16. Change in Quality Of Life: EORTC QLQ-C30 Version 3.0 [ Time Frame: Baseline to 3, 6, 9, 12, 24 and 36 months ]
    The cancer-specific questionnaire European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30 Version 3.0) measures health-related quality of life. Participants rate the degree that each item has applied to them during the past week on a four-point Likert scale (1, not at all; 4, very much). The average of the item scores gives a raw score, and the raw score will be transformed to a 0 to 100 scale. Higher scores indicate higher QOL.

  17. Completion of adjuvant treatment 1 [ Time Frame: 3 to 6 months ]
    At the end of adjuvant treatment, the percentage given by Oxaliplatin relative to the calculated full dose is calculated (%)

  18. Completion of adjuvant treatment 2 [ Time Frame: 3 to 6 months ]
    At the end of adjuvant treatment, the percentage given by Fluorouracil or Capecitabine relative to the calculated full dose is calculated (%)

  19. Completion of adjuvant treatment 3 [ Time Frame: 3 to 6 months ]
    At the end of adjuvant treatment,the total number of days the treatment courses have been delayed are calculated (days).

  20. Physical capacity [ Time Frame: Baseline to 3, 6 and 12 months. ]
    The submaximal exercise test, "Modified Shuttle Walk Test", is used to measure physical capacity. The test is performed three times in those who receives 3 months of adjuvant chemotherapy (baseline, 3 and 12 months), and four times in those who receives 6 months of adjuvant chemotherapy (baseline, 3, 6 and 12 months).

  21. Self-reported physical activity [ Time Frame: Baseline to 3, 6, 9, 12, 24 and 36 months ]
    Self-reported physical activity is measured using three questions from the Health Survey in Nord-Trøndelag (HUNT) which include frequency, duration and intensity of physical activity.

  22. Muscle strength [ Time Frame: Baseline to 3, 6 and 12 months. ]
    Strength of the lower limbs is indirectly measured by the test "Sit to Stand" which records how many times the patient is able to stand up and sit down from a chair within 30 seconds. This is measured three times for those who receives 3 months of adjuvant chemotherapy (baseline, 3 and 12 months). This is measured four times for those who receives 6 months of adjuvant chemotherapy (baseline, 3, 6 and 12 months).

  23. Balance 1 [ Time Frame: Baseline to 3, 6 and 12 months. ]
    Balance is measured with the test "Tandem standing". The test is performed with both closed and open eyes, and measures how many seconds (up to a maximum of 30 seconds), one can stand in the tandem position. The test is performed three times in those who receives 3 months of adjuvant chemotherapy (baseline, 3 and 12 months), and four times in those who receives 6 months of adjuvant chemotherapy (baseline, 3, 6 and 12 months).

  24. Balance 2 [ Time Frame: Baseline to 3, 6 and 12 months. ]
    Balance is measured with the test "Standing balance on one and one leg". The test is performed with both closed and open eyes, and measures how many seconds (up to a maximum of 30 seconds), one can stand on one leg. The test is performed three times in those who receives 3 months of adjuvant chemotherapy (baseline, 3 and 12 months), and four times in those who receives 6 months of adjuvant chemotherapy (baseline, 3, 6 and 12 months).

  25. Haematological toxicity [ Time Frame: Baseline to 6 months. ]
    Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, all grade 3 or more events for platelet- or neutrophil count will be registered. In addition, all admissions to hospital due to febrile neutropenia will be registered.

  26. Time before return to work [ Time Frame: Baseline to 3, 6, 9, 12, 24 and 36 months ]
    The rate of sick leave is recorded at baseline and every 3 months up to one year after inclusion using a questionnaire. This is also recorded after 2 and 3 years, using the same questionnaire.

  27. Overall- and disease free survival [ Time Frame: Baseline to 5 years ]
    Time of recurrence or death is recorded by annual journal review for up to 5 years after inclusion. This is defined as time from randomization to respectively recurrence or death.


Other Outcome Measures:
  1. Serious adverse events (SAE) [ Time Frame: Baseline to 6 months ]
    All serious events that may be related to the intervention will be recorded.

  2. Patient's expectations and experiences [ Time Frame: Baseline, 3 and 6 months ]
    Semi-structured interviews

  3. Medical treatment for hypertension. [ Time Frame: Baseline, 3, 6 and 12 months ]
    It will be registered whether the patient receives medical treatment for hypertension, and is answered with "yes" or "no". This will be recorded at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.

  4. Diagnosed with type 2 diabetes. [ Time Frame: Baseline, 3, 6 and 12 months ]
    It will be registered whether the patient is diagnosed With type 2 diabetes , and is answered with "yes" or "no". This will be recorded at baseline, after 3 and 12 months for those who receives 3 months of adjuvant chemotherapy, and at baseline, after 3, 6 and 12 months for those who receives 6 months of adjuvant chemotherapy.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radical resection for colon- or rectal cancer past 3 months, and scheduled for adjuvant, Oxaliplatin-based, combination chemotherapy.
  • Histologically confirmed adenocarcinoma.
  • Able to read and understand Norwegian.
  • Able to carry out the intervention.
  • Performance Status (PS) 0 - 2.

Exclusion Criteria:

  • Serious comorbidities that contraindicate physical exercise, based on the treating physician's assessment.
  • Unable to give informed consent.
  • Treated for other cancer last 5 years prior to inclusion (with the exceptions of basal cell carcinoma of the skin and carcinoma in situ in the cervix).
  • Prior treatment with Oxaliplatin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885817


Contacts
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Contact: Ingunn Hatlevoll, md +47 90866361 ingunn.hatlevoll@stolav.no
Contact: Eva Hofsli, md phd eva.hofsli@ntnu.no

Locations
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Norway
Sørlandet sykehus, Kristiansand Recruiting
Kristiansand, Norway
Levanger sykehus Recruiting
Levanger, Norway
Ullevål Recruiting
Oslo, Norway
Kreftklinikken, St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Ingun Hatlevoll, MD       ingunn.hatlevoll@stolav.no   
Ålesund sjukehus Not yet recruiting
Ålesund, Norway
Sponsors and Collaborators
St. Olavs Hospital
Alesund Hospital
Levanger Hospital
Ullevaal University Hospital
Sorlandet Hospital HF
Investigators
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Study Director: Arne Solberg, md phd St. Olavs Hospital
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03885817    
Other Study ID Numbers: 2015/1050
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Exercise therapy
Fatigue
Adjuvant chemotherapy
Peripheral neuropathy, chemotherapy induced
Nutritional guide
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases