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Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether low muscle mass is linked to harmful effects from chemotherapy. It is for older adults with newly diagnosed colorectal cancer (cancer of the colon or rectum) that has spread, or cancer that has returned and spread.

This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have newly diagnosed colorectal cancer that has spread, or cancer that returned and spread at least 3 months (12 weeks) after treatment for cancer that had not spread.
  • Plan to start or recently started a first treatment with immunotherapy (treatment that uses the immune system), 5-FU-based chemotherapy, or both. 5-FU may be given alone or with oxaliplatin and/or irinotecan. Capecitabine is also allowed.
  • Be expected to live at least 6 months.
  • Be able to understand English or Spanish to fill out surveys.
  • Be able to understand the study and willing to sign a consent form.
  • People of any weight or body mass index (BMI) may join. A weight gain or loss of more than 10% in the past 12 months is allowed.

Who can't join

  • Are enrolled in hospice care.
  • Have had chemotherapy that treats the whole body for colorectal cancer that has spread. Chemotherapy given after treatment for earlier-stage cancer is allowed if it ended at least 3 months (12 weeks) before the cancer returned and treatment began.
  • Are receiving any other experimental drugs.
  • Have cancer that has spread to the brain and has not been treated. Treated brain cancer spread is allowed.
  • Are receiving radiation therapy or plan to receive it soon.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC. * Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable. * Estimated life expectancy \>= 6 months. * Patients must be able to comprehend English or Spanish (for questionnaire completion). * Ability to understand and the willingness to sign a written informed consent document. * Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- \> 10%) body weight change in the previous 12 months are eligible for this study. Exclusion Criteria: * Patients enrolled on hospice. * Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \>= 3 months (12 weeks) prior to this disease disease recurrence and treatment). * Patients may not be receiving any other investigational agents. * No untreated brain metastases. Patients with treated brain metastases are eligible. * Patients on or planned to undergo radiation therapy in near future.

Study sites (147)

DC

DE

GA

IA

IL

KY

LA

MI

MN

MO

NC

ND

OH

PA

SC

SD

WI