Strength Training for Head and Neck Cancer Survivors

(LIFTING2 Trial)

Overseen By Stephanie Ntoukas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Recent strength training, Other trials

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

60 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Heavy Strength Training for head and neck cancer survivors?

Research shows that strength training, including progressive resistance training, can help rebuild muscle mass and improve muscle strength in head and neck cancer patients after treatment. This type of exercise has also been associated with better quality of life and reduced fatigue in these patients. ^{1 2 3 4 5}

Is strength training safe for head and neck cancer survivors?

Research shows that heavy lifting strength training is generally safe for head and neck cancer survivors, even after surgery, and can improve muscle strength and physical functioning. ^{1 3 6 7 8}

How does heavy strength training differ from other treatments for head and neck cancer survivors?

Heavy strength training is unique because it involves lifting heavier weights than typically used in light-to-moderate strength training, which may lead to greater improvements in muscle strength and physical functioning for head and neck cancer survivors. This approach has not been previously studied in this specific group, making it a novel treatment option. ^{1 3 4 8 9}

What is the purpose of this trial?

Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS.

Research Team

Kerry Courneya

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for head and neck cancer survivors who have finished their treatment. It's designed to see if heavy lifting strength training can help with muscle strength, physical function, fatigue, and swallowing issues that affect life quality.

Inclusion Criteria

Approved for exercise by oncologist and a certified exercise physiologist or kinesiologist

I have any type or stage of head and neck cancer.

No unmanaged medical conditions, alcohol, or drug abuse

Exclusion Criteria

Has met the Canadian Physical Activity strength training guidelines within the past one month: at least two days per week of muscle and bone strength training activities using major muscle groups

Currently involved in a different exercise trial or clinical drug trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the exercise group undergo 12 weeks of heavy lifting strength training, while the usual care group continues their typical routine without new exercise programs.

12 weeks

24 supervised exercise sessions for the exercise group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of muscular strength, physical function, and quality of life.

4 weeks

Optional Extension

Participants in the usual care group are offered a 4-week introduction to heavy lifting strength training program and/or referred to a community-based exercise program.

4 weeks

Treatment Details

Interventions

• Heavy Strength Training

Trial Overview The LIFTING 2 trial is testing the benefits of a heavy lifting strength training program compared to no exercise at all in people who've survived head and neck cancer. The goal is to improve their muscular strength and overall well-being.

Participant Groups

Group I: Exercise Group Experimental Treatment 1 Intervention

The exercise intervention will consist of 24 supervised, heavy lifting strength training exercise sessions over a 12 week period. The exercise frequency will be two times per week. Main exercises will consist of barbell back squat, bench press, and dead lift.

Group II: Usual Care Group Active Control 1 Intervention

Participants randomized to the usual care group will be asked to continue will their typical daily routine during the 12 week study period, and not begin any new exercise program to increase their exercise levels from baseline. They will not receive any information or education regarding exercise. After the postintervention assessments, participants in the usual care group will be offered a 4-week introduction to heavy lifting strength training program and/or referred to a community-based exercise program

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

A 12-week strength training program, including novel strength training (NST) with eccentric overload and neuromuscular electrical stimulation (NMES), was feasible for head and neck cancer patients, showing high completion (100% NST, 82% CST) and adherence rates (92% NST, 81% CST).

Both NST and conventional strength training significantly improved muscle strength, muscle size, and health-related quality of life, suggesting that these interventions can effectively aid recovery after head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of eccentric overloading and neuromuscular electrical stimulation to improve muscle strength and muscle mass after treatment for head and neck cancer. Lavigne, C., Twomey, R., Lau, H., et al.[2021]

Only a small percentage of head and neck cancer survivors engage in regular exercise, with 44% reporting light exercise and only 8.5% meeting public health guidelines, indicating a significant need for increased physical activity in this group.

Total exercise minutes were positively associated with functional well-being and quality of life, while also being negatively associated with fatigue, suggesting that even light exercise could improve health outcomes for these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and quality of life in head and neck cancer survivors. Rogers, LQ., Courneya, KS., Robbins, KT., et al.[2022]

Progressive resistance training (PRT) significantly increased lean body mass and muscle strength in head and neck squamous cell carcinoma (HNSCC) patients after radiotherapy, regardless of whether the training started early or was delayed.

Patients who began PRT earlier showed greater improvements in quality of life compared to those who started later, highlighting the benefits of early intervention in enhancing recovery post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive resistance training rebuilds lean body mass in head and neck cancer patients after radiotherapy--results from the randomized DAHANCA 25B trial. Lønbro, S., Dalgas, U., Primdahl, H., et al.[2019]

A 12-week progressive resistance training (PRT) program during concomitant chemoradiotherapy (CCRT) for head and neck cancer was feasible, with 75% of participants completing the majority of sessions and reporting high satisfaction.

The PRT helped maintain functional performance and regain muscle strength, with lean body mass starting to increase immediately after treatment, indicating potential benefits for patients undergoing CCRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive resistance training in head and neck cancer patients undergoing concomitant chemoradiotherapy. Lonkvist, CK., Vinther, A., Zerahn, B., et al.[2020]

Exercise-based rehabilitation can improve functionality and reduce fatigue in head and neck cancer survivors who have undergone chemoradiotherapy, as shown in a meta-analysis of 18 studies involving 1322 participants.

Despite the benefits in functionality, the study found no significant improvements in the overall quality of life for these survivors, indicating that while exercise may help with physical aspects, it does not necessarily enhance overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based rehabilitation on functionality and quality of life in head and neck cancer survivors. A systematic review and meta-analysis. Pérez, IMM., Pérez, SEM., García, RP., et al.[2023]

In a study of 48 head and neck cancer patients undergoing treatment, significant loss of lean body mass (LBM) was observed as early as two weeks into radiation therapy, with further declines noted through week six.

Patients receiving cisplatin-based chemoradiation (CCRT) experienced a greater loss of LBM (3.1 kg) compared to those receiving radiation alone, highlighting the impact of CCRT on muscle health during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated loss of lean body mass in head and neck cancer patients during cisplatin-based chemoradiation. Lønbro, S., Gam, S., Hermann, AP., et al.[2023]

The exercise program for head and neck cancer patients undergoing chemoradiotherapy showed low overall adherence (54%) and retention (65%), indicating that while the program is feasible for some, it needs improvements to engage more patients effectively.

Despite the intention to counteract negative effects of treatment, significant declines in grip strength, fat-free mass, and quality of life were observed, suggesting that the current exercise intervention may not sufficiently mitigate the adverse impacts of chemoradiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy. Kok, A., Passchier, E., May, AM., et al.[2022]

The LIFTING trial demonstrated that heavy lifting strength training (HLST) is feasible and safe for head and neck cancer survivors, with 100% of participants successfully completing the program and no adverse events reported.

Participants showed significant improvements in muscular strength, with median increases of 34 kg in squat/leg press, 6 kg in bench press, and 12 kg in deadlift over the 12-week program, indicating HLST may enhance physical functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and safety of Heavy Lifting Strength Training in Head and Neck Cancer survivors post-surgical neck dissection (the LIFTING trial). Ntoukas, SM., McNeely, ML., Seikaly, H., et al.[2023]

Progressive resistance training (PRT) is feasible and well-tolerated in patients with head and neck squamous cell carcinoma (HNSCC), with a high adherence rate of 97% over 12 weeks.

Both the PRT group with protein and creatine supplementation and the placebo group showed significant increases in lean body mass, muscle strength, and functional performance, indicating that PRT can effectively enhance physical health in HNSCC patients, regardless of dietary supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of progressive resistance training and dietary supplements in radiotherapy treated head and neck cancer patients--the DAHANCA 25A study. Lønbro, S., Dalgas, U., Primdahl, H., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of eccentric overloading and neuromuscular electrical stimulation to improve muscle strength and muscle mass after treatment for head and neck cancer. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Physical activity and quality of life in head and neck cancer survivors. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Progressive resistance training rebuilds lean body mass in head and neck cancer patients after radiotherapy--results from the randomized DAHANCA 25B trial. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Progressive resistance training in head and neck cancer patients undergoing concomitant chemoradiotherapy. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Exercise-based rehabilitation on functionality and quality of life in head and neck cancer survivors. A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Accelerated loss of lean body mass in head and neck cancer patients during cisplatin-based chemoradiation. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility of a supervised and home-based tailored exercise intervention in head and neck cancer patients during chemoradiotherapy. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and safety of Heavy Lifting Strength Training in Head and Neck Cancer survivors post-surgical neck dissection (the LIFTING trial). [2023]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of progressive resistance training and dietary supplements in radiotherapy treated head and neck cancer patients--the DAHANCA 25A study. [2019]